Trial Condition(s):
Chronic Bronchitis
Moxifloxacin versus amoxicillin clavulanic acid in treatment of acute exacerbation of chronic bronchitis
Bayer Identifier:
11980
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.
Inclusion Criteria
- Outpatients with chronic bronchitis - Male or female subjects, >=60 years old - Post bronchodilator forced expiratory volume in one second (FEV1) less than or equal to 60% predicted and FEV1 / forced vital capacity (FVC) less than 70% at enrollment - Documented history of 2 or more AECB episodes, within 12 months of study enrollment, requiring a course of systemic antibiotics and/or systemic corticosteroids - All symptoms/signs must be present and confirmed by the Investigator: -- increase in dyspnea -- purulent sputum -- increase in sputum volume - Current or past cigarette smoker with equal to or greater than 20 pack year smoking history - Subjects must be exacerbation free for at least 30 days prior to enrollment - Subjects must be willing and able to complete the questionnaires and subject booklet without assistance
Exclusion Criteria
- Known hypersensitivity to quinolones, ß lactams, or to any of the excipients of the study drugs - Known to have congenital or acquired QT prolongation - Known to have clinically relevant bradycardia - Known to have clinically relevant heart failure with reduced left ventricular ejection fraction - Known to have previous history of symptomatic arrhythmias - Taking QT prolonging drugs, for example Class Ia or III antiarrhythmic agents or other QT prolonging drugs - Known electrolyte disturbances that are not controlled, particularly uncorrected hypokalemia - Known history of hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose galactose malabsorption - History of a tendon disease/disorder - Known history of liver dysfunction (Child-Pugh C), including known elevated transaminase levels (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >5 times the upper limit of normal [5 x ULN]) - Known severe renal impairment with glomerular filtration rate of <30 mL/min - Known neutropenia (neutrophil count <1000/mm3) caused by immunosuppressive therapy or malignancy - Known to have Acquired Immunodeficiency Syndrome (AIDS) (CD4 count of <200/mm3), or be human immunodeficiency virus (HIV) positive and receiving highly active anti retroviral therapy (HAART) (testing for HIV is not mandatory) - Known chronic asthma (>15% reversibility or at least 200 mL), bronchial carcinoma, active pulmonary tuberculosis, known diffuse bronchiectasis, cystic fibrosis, or pneumonia (a chest x ray is not mandatory) - Known history of chronic colonization of pathogenic organisms resistant to moxifloxacin and/or amoxicillin clavulanic acid (eg, P. aeruginosa, methicillin resistant Staphylococcus aureus) - Receiving long term (>4 consecutive weeks) systemic corticosteroid treatment (>10 mg/day of prednisolone or equivalent) - Received short course of systemic corticosteroid treatment within 30 days prior to enrollment - Life expectancy of less than 6 months - Receiving systemic antibacterial therapy within 30 days prior to study enrollment - Requiring concomitant systemic antibacterial agents - Requiring home ventilatory support (subjects requiring home/portable oxygen therapy or continuous positive airway pressure (CPAP) for sleep apnea are not excluded) and/or those who have a tracheotomy in situ - History of liver function disorders following previous treatment with amoxicillin-clavulanic acid - Receiving disulfiram therapy
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Praxis Hr. Dr. A. Colberg Bad Segeberg, Germany, 23795 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. R. Gebhardt Berlin, Germany, 12043 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulantes Zentrum für Lungenkrankheiten Cottbus, Germany, 03050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. Th. Schultz Berlin, Germany, 12203 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. G. Hoheisel Leipzig, Germany, 04275 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. Laumen/Wiederhold Fulda, Germany, 36039 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. M. Huntemann Lüdenscheid, Germany, 58515 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gemeinschaftspraxis Innere Medizin Augsburg, Germany, 86150 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. K. Todoroff Bad Dürrheim, Germany, 78073 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. J. C. Becker Lübeck, Germany, 23552 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gemeinschaftspraxis & Zentrum Frankfurt, Germany, 60318 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. K. Böhm Neubrandenburg, Germany, 17033 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. C. Geßner Leipzig, Germany, 04357 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs.Deckelmann/Eckhardt Leipzig, Germany, 04207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. J. Hampf Meißen, Germany, 01662 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis fü Lungen- und Bronchialheilkunde, Berlin, Germany, 10717 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IFG Institut für Gesundheitsförderung GmbH Rüdersdorf, Germany, 15562 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. M. Raffenberg Zossen, Germany, 15806 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. Westerhausen/Pettenkofer/Klüppelberg Berlin, Germany, 10969 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gemeinschaftspraxis Drs. Hartjen, Sostmann, Timmermann Hamburg, Germany, 20354 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinisches AllergoPneumologisches Versorgungszentrum Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A. de Roux Berlin, Germany, 14059 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. J. Groth Neuwied, Germany, 56564 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinsches Versorgungszentrum Delitzsch Delitzsch, Germany, 04509 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. J. Eller Berlin, Germany, 13597 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gemeinschaftspraxis Dr. Grützmacher / Dr. tenHoff Hamburg, Germany, 22305 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. H.-H. Ponitz / Hr. Dr. G. Hoppe Berlin, Germany, 10365 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A. Schwittay Böhlen, Germany, 04564 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Baillieston Health Centre Glasgow, United Kingdom, G69 7AD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre d'allergologie et de pneumologie respiratoire PERPIGNAN, France, 66025 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale San Giuseppe FbF Polo Universitario Milano, Italy, 20123 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Sacco Polo Universitario Milano, Italy, 20157 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Perugia Perugia, Italy, 06156 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL Salerno - Campania Pregiato di Cava dei Tirreni, Italy, 84013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AULSS 22 Bussolengo - Veneto Bussolengo, Italy, 37012 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General de Requena Requena, Spain, 46340 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scimed Research, Inc. Kelowna, Canada, V1Y 8E7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Antigonish Clinical Trials Antigonish, Canada, B2G 2C2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHUM - Hopital Notre-Dame Montreal, Canada, H2L 4M1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Q & T Research, Inc. Sherbrooke, Canada, JIH 4J6 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Calgary Calgary, Canada, T2N 4Z6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St.Joseph's Health Care-London London, Canada, N6A 4V2 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Anderston Medical Centre Glasgow, United Kingdom, G3 8YJ | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Park Leys Medical Practice Coventry, United Kingdom, CV7 8LA | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Surgery Glasgow, United Kingdom | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thornliebank Health Centre Glasgow, United Kingdom, G46 8NY | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Castlemilk Health Centre Glasgow, United Kingdom, G45 9AW | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet médical - Cronstadt - Nice NICE, France, 06000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Morgiou - Marseille MARSEILLE, France, 13009 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Martinon - Mont de Marsan MONT-DE-MARSAN, France, 40000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 2 Lanciano-Vasto-Chieti - Abruzzo Chieti, Italy, 66100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASUR Marche ZT13 Ascoli Piceno Ascoli Piceno, Italy, 63100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Ospedale Circolo Busto Arsizio Busto Arsizio , Italy, 21052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ARNAS Garibaldi Catania, Italy, 95122 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Status Completed | Contact Us: E-mail: [email protected]erhealthcare.com Phone: Not Available |
Locations Hospital Universitari Son Espases Palma de Mallorca, Spain, 07010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Universitario de Guadalajara Guadalajara, Spain, 19002 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Joseph's Healthcare - Hamilton Hamilton, Canada, L8N 4A6 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Clinic Sydney Mines, Canada, B1V 2Y5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Grey Nun's Community Hospital Edmonton, Canada, T6L 5X8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Health Science Centre Winnipeg, Canada, R3A 1R8 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Primary Care Lung Clinic Toronto, Canada, M6H 3M2 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr.Robert Luton, MD London, Canada, N6A 5G6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Invascor Inc. Longueuil, Canada, J4N 1E1 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations JBN Medical Diagnostic Services, Inc. Burlington, Canada, L7R 3X4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU de Mont-Godinne YVOIR, Belgium, 5530 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Vereecken HALEN, Belgium, 3545 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Catharina EINDHOVEN, Netherlands, 5623 EJ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Diaconessenhuis Meppel MEPPEL, Netherlands, 7943 KA | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Diakonessenhuis UTRECHT, Netherlands, 3582 KE | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Central Universitario Chihuahua, Mexico, 31350 | Status Completed | Contact Us: E-mail: [email protected]om Phone: Not Available |
Locations Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" Guadalajara, Mexico, 44280 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Médico de las Américas Mérida, Mexico, 97001 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General del Parc Sanitari de Sant Joan de Déu Sant Boi de Llobregat, Spain, 08830 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CAP Sarrià Barcelona, Spain, 08034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consorci d’Atenció Primària de Salut de l’Eixample Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Tharwat Fera, MD Vancouver, Canada, V5Z 4E1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Winnipeg Clinic Winnipeg, Canada, R3C 0N2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Alberta Edmonton, Canada, T6G 2B7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Graham W. Bishop, MD Saint John, Canada, E2M 3W5 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Brian Craig, MD Saint John, Canada, E2K 2T8 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Algemeen Stedelijk Ziekenhuis Campus Aalst AALST, Belgium, 9300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sint-Vincentiusziekenhuis Campus Sint-Vincentiusziekenhuis ANTWERPEN, Belgium, 2018 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. MARTINOT Jean-Benoît NAMUR, Belgium, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU Brugmann/UVC Brugmann BRUXELLES - BRUSSEL, Belgium, 1020 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Hutsebaut MOERKERKE, Belgium, 8340 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Huysmans LOMMEL, Belgium, 3920 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Atrium Medisch Centrum Parkstad HEERLEN, Netherlands, 6419 PC | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Spaarne Ziekenhuis HOOFDDORP, Netherlands, 2134 TM | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Ángeles Lomas Huixquilucan, Mexico, CP 52763 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital San Agustín Zacatecas Zacatecas, Mexico, 98608 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Worthwhile Clinical Trials Benoni, South Africa, 1500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Paarl Research Centre Paarl, South Africa, 7647 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinresco Kempton Park Kempton Park, South Africa, 1610 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations I. Engelbrecht Reseach (Pty) Ltd Centurion, South Africa, 0140 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Stellenbosch Cape Town, South Africa, 7505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vergelegen Medi-Clinic Somerset West, South Africa, 7130 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Emmed Research Pretoria, South Africa, 0084 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Intercare Medical & Dental Centre Glenfair Pretoria, South Africa | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations sunnyside Mediclinic Pretoria, South Africa, 0002 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Newkwa Medical Centre Durban, South Africa, 4037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinic of pulmonary diseases Neratovice, Czech Republic, 227 11 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Kyjov Kyjov, Czech Republic, 697 01 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SPIiN Praha - Troja, Czech Republic, 182 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Metropolitano "Dr. Bernardo Sepúlveda" Monterrey, Mexico, 66480 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General O'Horán SS Mérida, Mexico, 97001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Unidad de Investigación Clínica en Medicina Monterrey, Mexico, 64718 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Josha Research Bloemfontein, South Africa, 9324 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Randles Road Medical Centre Durban, South Africa, 4091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Park Medical Centre Witbank, South Africa, 1035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tambotie Medical Centre Thabazimbi, South Africa, 0380 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mercantile Hospital Centre Port Elizabeth, South Africa, 6014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinic of pulmonary diseases Praha - Malesice, Czech Republic, 108 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinic of pulmonary diseases and internal medicine Lovosice, Czech Republic, 410 02 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Charles Gairdner Hospital Nedlands, Australia, 6009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Repatriation General Hospital Adelaide, Australia, 5041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Concord Repatriation General Hospital Concord, Australia, 2139 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Hospitalar de Lisboa Ocidental-Hospital Santa Marta Lisboa, Portugal, 1169-024 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Hospitalar Vila Nova de Gaia Vila Nova de Gaia, Portugal, 4434-502 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinic of pulmonary diseases Pardubice - Trnova, Czech Republic, 530 09 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth Hospital Woodville, Australia, 5011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brisbane Mater Misericordiae Hospital Brisbane, Australia, 4101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Hospitalar Torres Vedras.H.Dr José Maria Antunes Jr Torres Vedras, Portugal, 2560-324 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Santarém Santarém, Portugal, 2005-177 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Pedro Hispano Matosinhos, Portugal, 4454-509 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Médico de Asistencia e Investigación Buenos Aires, Argentina, C1425AWC | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Militar Central "CIR. MY. C. Argerich" Buenos Aires, Argentina, 1426 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Respiratorio Quilmes Quilmes, Argentina | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigaciones en Patologías Respiratorias San Miguel de Tucumán, Argentina | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inst. de Dermatología y Neumonología "Dr. Carlos Luna" Buenos Aires, Argentina | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Médico Dra. De Salvo - Clinical Research Center Buenos Aires, Argentina, 1426 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Carlos van Buren Valparaíso, Chile | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nacional del Tórax Santiago , Chile | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Ciudad del Mar Viña del Mar, Chile | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Hospitalar Coimbra S. Martinho do Bispo, Portugal, 3041-856 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Hospitalar de Lisboa Norte - Hospital Santa Maria Lisboa, Portugal, 1649-035 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospitais da Universidade de Coimbra Coimbra, Portugal, 3000-075 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de São João Porto, Portugal, 4200 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Zonal de Agudos Dr. Antonio Cetrángolo Vicente López, Argentina, 1638 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fund. Asistencia e Inv. Clínica en Enferm. Prevalentes Buenos Aires, Argentina | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Centro de Salud Zenon Santillan San Miguel de Tucumán, Argentina, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Investigaciones Médicas Florencio Varela, Argentina | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica del Sol Buenos Aires, Argentina | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Enfermedades Respiratorias Buenos Aires, Argentina, C1424BSF | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Gustavo Fricke Viña del Mar, Chile | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Militar Central Santafe de Bogotá, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Médico Imbanaco Cali, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Neumológico de Oriente Bucaramanga, Colombia | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Soma Medellín, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinica Avansalud Santiago, Chile | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NeumoInvestigaciones Bogotá, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Neumológica Colombiana Bogotá, Colombia | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital San Vicente de Paul Medellín, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Clínica Valle del Lili Cali, Colombia | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Medellín Medellín, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University General Hospital of Patras Rio , Greece, 265 04 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University General Hospital of Larissa Mezourlo, Greece, 41110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Evangelismos General Hospital of Athens Athens, Greece, 106 76 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pontificia Universidade Católica do RS - Centro Clínico Porto Alegre, Brazil, 90610-000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universidade Federal de Juiz de Fora- Hospital Universitario Juiz de Fora, Brazil, 36036-110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital das Clínicas da Faculdade de Medicina da USP São Paulo, Brazil, 05403-900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations first affiliated hospital of guangzhou medical college Guangzhou, China, 510120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West China Hospital, Sichuan University Chengdu, China, 610041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Investigación Clínica FOQUS Bogotá, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sotiria General State Hospital of Chest Diseases Athens, Greece, 11527 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations General University Hospital of Ioannina Ioannina, Greece, 45500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UNIFESP/EPM São Paulo, Brazil, 04032-060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shanghai Changzheng Hospital Shanghai, China, 200003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Respiratory Diseases Institute, Beijing Chaoyang Hospital Beijing, China, 100020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shengjing Hosp. of China Medical Univ. Shengyang, China, 110004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliated Hosp., Guangzhou Univ. TCM Guangzhou, China, 510405 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Soetomo Hospital Surabaya, Indonesia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vilnius region outpatient department Vilnius, Lithuania, LT-06122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saules family medicine center Kaunas, Lithuania, LT-50425 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Silainiu family health center Kaunas, Lithuania | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. U. Honegger Zürich, Switzerland, 8048 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. T. Toth Thun, Switzerland, 3600 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The 6th People's Hospital of Shanghai Jiao Tong University Shanghai, China, 200233 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shanghai Huadong Hospital Shanghai, China, 200040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations General Hospital, Tianjin Medical University Tianjin, China, 300052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Beijing Friendship Hosp. Beijing, China, 100050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The First hospital of China Medical University Shenyang, China, 110001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Third Xiangya Hospital of Central South University Changsha, China, 410013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Persahabatan Hospital Jakarta , Indonesia, 13230 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Immanuel Hospital Bandung, Indonesia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seskines outpatient clinic Vilnius, Lithuania, LT-07156 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UAB "Mano seimos gydytojas" Klaipeda, Lithuania, LT-94231 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Siauliai County Hospital Siauliai, Lithuania, 76231 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. R. Siebenschein Wettingen, Switzerland, 5430 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. med. P. Ruff Oberwil, Switzerland, 4104 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. med. Martin Anton Tschan Laufen, Switzerland, 4242 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Spital Netz Bern Spital Tiefenau Bern, Switzerland, 3004 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lungenpraxis Aarau Aarau, Switzerland, 5000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. med. Alexander Haegeli Binningen, Switzerland, 4102 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Zürich Zürich, Switzerland, 8091 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica San Pablo Lima, Peru, 33 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Alberto Sabogal Sologuren Callao, Peru, CALLAO 2 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Central de la Fuerza Aerea del Perú Lima, Peru, LIMA 18 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Internacional Lima, Peru | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nacional Cayetano Heredia Lima, Peru, 31 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tuen Mun Hospital HongKong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Manila Doctors Hospital Manila, Philippines | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lung Center of the Philippines Quezon City, Philippines | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Latvian Postdiploma Education Institute Ambulatory part Riga, Latvia, 1011 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr E Tirans Private Practice Riga, Latvia, 1009 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Harasimjukas private practice Valmiera, Latvia, 4201 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ltd "BINI" (SIA "BINI") Ventspils, Latvia, LV-3601 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinika za plucne bolesti Jordanovac Zagreb, Croatia, 10000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica El Golf Lima, Peru, LIMA 27 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princess Margaret Hospital Kowloon, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chest Disease Institute Nonthaburi , Thailand, 11000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maharaj Nakorn Chiang Mai Hospital Chiang Mai , Thailand, 50200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations King Chulalongkorn Memorial Hospital Bangkok, Thailand, 10330 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Ntra. Sra. de Meritxell Escaldes - Engordany, Andorra | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gimenes Arstu prakse Riga, Latvia, 1050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SIA Talsi veselibas centrer Talsu, Latvia, 3201 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kraslavas hospital Kraslava, Latvia, 5601 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations KBC Rijeka Rijeka, Croatia, 510 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations OB dr. Ivo Pedisic Petrinja, Croatia, 44 250 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gorey Medical Centre Gorey, Ireland | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Farranfore Medical Centre Killarney, Ireland | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Palms Gorey, Ireland | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Longford Centre Longford, Ireland | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinika za plucne bolesti Jordanovac Zagreb, Croatia, 10000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations KB Osijek Osijek, Croatia, 310 00 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinicka bolnica Dubrava Zagreb, Croatia, 10000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Townhall Clinic Bray, Ireland | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jinnah Postgraduate Medical Centre Karachi, Pakistan, 75500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Liaquat National Hospital Karachi, Pakistan, 74800 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shifa International Hospitals Limited Islamabad, Pakistan | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. C. Keller Frankfurt, Germany, 60389 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Slaney Medical Centre Enniscorthy, Ireland | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
MAESTRAL - A prospective, multinational, multicenter, randomized, double blind, double dummy, controlled study comparing the efficacy and safety of moxifloxacin to that of amoxicillin clavulanic acid for the treatment of subjects with acute exacerbations of chronic bronchitis.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Clinical failure at 8 weeks post therapyTimeframe: At day 63
Secondary Outcome
- Clinical failure ratesTimeframe: Through to day 35
- Bacteriological eradication ratesTimeframe: Through to day 63
- Clinical failure rates for subjects with positive sputum culture at enrollmentTimeframe: Through to day 63
- Weekly mean symptom scores measured by the AECB SSTimeframe: Through to day 63
- Rates and speed of symptom relief measured by the AECB SSTimeframe: Through to day 63
- Clinical failure rates for subjects with co-administration of systemic corticosteroids (stratum 1)Timeframe: Through to day 63
- Clinical failure rates for subjects without co-administration of systemic corticosteroids (stratum 2)Timeframe: Through to day 63
- Need for any change in dosage or additional respiratory medication such as bronchodilators and inhaled steroids, excluding short acting bronchodilatorsTimeframe: Through to day 63
- Improvement in symptoms burden measured by the AECB SSTimeframe: Through to day 63
- Improvement in health related QoL measured by the SGRQTimeframe: Through to day 63
- spirometry tests will be compared between treatment groupsTimeframe: Through to day 63
- HCRU relat. to chronic bronchitis management incl. rescue med., concomitant med., therap. adjuncts, diagn. procedures, other medical care/medical staff requirement, hospitalizations (incl. ward and duration), and work productivity and activity impairmentTimeframe: Through to day 63
- Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrheaTimeframe: Through to day 63
Additional Information
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