Trial Condition(s):
Pneumonia
Efficacy and safety of sequential IV/PO moxifloxacin in comparison to IV levofloxacin plus IV ceftriaxone followed by PO levofloxacin, in the treatment of patients with community-acquired pneumonia
Bayer Identifier:
11215
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Sequential therapy with intravenous to oral moxifloxacin, was tested at 69 study centres in 17 countries to determine if this treatment regimen is safe and effective in treating hospitalized adult patients with community-acquired pneumonia. 748 patients were participated in the study over an 18 months period. Individual patient involvement in the study was approximately 4-6 weeks. Moxifloxacin was compared to a combination treatment regimen of high dose intravenous ceftriaxone plus high dose intravenous levofloxacin followed by high dose oral levofloxacin.
Inclusion Criteria
- Patients aged 18 years or above - All of the following signs and symptoms of pneumonia: -- Fever (core/ rectal/ tympanic temperature >/= 38.5°C or axillary/ oral/ cutaneous temperature >/= 38.0°C) or hypothermia (core/ rectal/ tympanic temperature </= 35.5°C or axillary/ oral/ cutaneous temperature </= 35.0°C) -- White blood cell (WBC) count > 10,000/µL, or >/= 15% immature neutrophils (bands), regardless of the peripheral WBC count, or total WBC count < 4,500/µL -- The presence of at least 2 of the following symptoms: - Cough- Purulent sputum production - Dyspnoea or tachypnoea (respiratory rate > 20 breaths/minute) - Rigors and/or chills- Chest pain - Auscultatory findings on pulmonary examination of rales/crackles and/or evidence of pulmonary consolidationAND - Radiological evidence of (an) infiltrate(s) consistent with bacterial pneumonia at baseline or within 24 hours following enrolment - Fine score >/= 71 (i.e. Pneumonia PSI risk Class III, IV or V, requiring hospitalisation for the treatment of CAP) - Written informed consent obtained from the patient or a next-of-kin
Exclusion Criteria
- Known hypersensitivity to fluoroquinolones, or other quinolones, and/or to beta-lactams, or any of the excipients - Female patients who are pregnant or lactating - History of tendon disease/disorder related to quinolone treatment - Known congenital or documented-acquired QT prolongation; concomitant use of drugs, reported to increase the QT interval; uncorrected hypokalaemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left - ventricular ejection fraction; previous history of symptomatic arrhythmias - History of epilepsy- Known glucose-6-phosphate dehydrogenase deficiency - Known severe impaired liver function (i.e. Child Pugh C), (refer to Section 10.4 for definition) or transaminases increase > 5 fold ULN- Hospitalisation for > 48 hours before developing pneumonia, or discharge from hospital < 30 days prior- Systemic antibacterial therapy for more than 24 hours within 14 days of enrolment - Patients requiring concomitant systemic antibacterial agents - Known structural lung disease (e.g. cystic fibrosis, bronchiectasis, or lung cancer), or other known conditions (e.g. malnutrition) predisposing to infection with nosocomial-like organisms such as Pseudomonas aeruginosa - Lung abscess, pleural empyema, risk factors for aspiration pneumonia (e.g. recent stroke, head injury, dementia) - Known rapidly fatal underlying disease (death expected within 6 months) - Known or suspected active tuberculosis or endemic fungal infection- Neutropenia (neutrophil count < 1,000/µL) caused by immunosuppressive therapy or malignancy - Patients known to have AIDS (CD4 count < 200/µL) or HIV-seropositive patients receiving HAART - Previous enrolment in this study - Participation in any clinical investigational drug study within the previous 4 weeks - Patient with pre-terminal renal failure (creatinine clearance < 10 mL/min) and patients undergoing haemodialysis
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Brüderkrankenhaus St. Josef Paderborn, Germany, 33098 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University General Hospital of Patras Rio, Greece, 265 04 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tel Aviv Sourasky Medical Center Tel Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vilnius Center University Hospital Vilnius, Lithuania, LT-2001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Catharina Ziekenhuis EINDHOVEN, Netherlands, 5623 EJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nacional Arzobispo Loayza Lima Cercado, Peru, LIMA 1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 00-909 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Pulido Valente Lisboa, Portugal, 1769-001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Ryhov Jönköping, Sweden, 551 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Groote (new) Schuur Hospital Cape Town, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno" Buenos Aires, Argentina, C1431FWO | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Santa Clara Santafé de Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Otto-von Guericke - Magdeburg Magdeburg, Germany, 39112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Clínicas "José de San Martín" Buenos Aires, Argentina, C1120AAF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Carabineros Santiago de Chile, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Militar Central Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier - Brive La Gaillarde BRIVE-LA-GAILLARDE, France, 19100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Hallamshire Hospital Sheffield, United Kingdom, S10 2JF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" Guadalajara, Mexico, 44280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Sainte-Elisabeth NAMUR, Belgium, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Dr. Sotero del Río Santiago de Chile, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier - Saint Gaudens SAINT-GAUDENS, France, 31806 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Daniel A. Carrión Callao, Peru, 02 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instytut Gruzlicy i Chorob Pluc Warszawa, Poland, 01-138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meulmed Hospital Pretoria Pretoria, South Africa, 0083 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Universitario de Guadalajara Guadalajara, Spain, 19002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Pellegrin Tripode - Bordeaux BORDEAUX, France, 33000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dumfries & Galloway Royal Infirmary Dumfries, United Kingdom, DG1 4EP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AHEPA University General Hospital of Thessaloniki Thessaloniki, Greece, 546 36 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Haemek Medical Center Afula, Israel, 18101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vilnius Mykolo Marcinkeviciaus Hospital Vilnius, Lithuania, LT-2006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Médico Nacional "La Raza" México, D.F., Mexico, 02290 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ziekenhuis Gelderse Vallei EDE, Netherlands, 6716 RP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kärnsjukhuset Skövde, Sweden, 541 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Alemán Buenos Aires, Argentina, C1118AAT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asistencia Pública Dr. Alejandro del Río Santiago, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Neumológico de Oriente Bucaramanga, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rotherham District General Hospital Rotherham, United Kingdom, S60 2UD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sotiria General State Hospital of Chest Diseases Athens, Greece, 11527 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Barzilai Medical Center Ashkelon Ashkelon, Israel, 78306 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaunas 2nd Clinical Hospital Kaunas, Lithuania, 47144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersytet Medyczny Lodz, Poland, 91-425 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centralsjukhuset Karlstad, Sweden, 651 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Witwatersrand Johannesburg, South Africa, 2132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sanatorio Güemes Buenos Aires, Argentina, C1180AAX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Berufsgenossenschaftl. Kliniken Bergmannstrost Halle, Germany, 06112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Général - Belfort BELFORT, France, 90016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaunas District Hospital Kaunas, Lithuania, 45130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Uniwersytecki CMUJ Krakow, Poland, 30-501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Zonal de Agudos Dr. Antonio Cetrángolo Vicente López, Argentina, B1602DOH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional De Temuco Temuco, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations C.H.G. Paul Morel - Vesoul VESOUL, France, 70014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations James Cook University Hospital Middlesborough, United Kingdom, TS4 3BW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nicolás San Juan Toluca, Mexico, 50130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bfg Kliniken Bergmannsheil, Universitätsklinik Bochum, Germany, 44789 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General "Manuel Gea González" México, D.F., Mexico, 14000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jeroen Bosch Ziekenhuis, lokatie Groot Ziekengasthuis DEN BOSCH, Netherlands, 5211 RB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Dos de Mayo Lima, Peru, 01 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU de Liège LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Gustavo Fricke Viña del Mar, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Freeman Hospital Newcastle Upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chaim Sheba Medical Center Tel Hashomer, Israel, 52621 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario "José Eleuterio González" Monterrey, Mexico, 64460 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Atrium Medisch Centrum HEERLEN, Netherlands, 6419 PC | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Kalmar, Sweden, 391 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Private Practice Armansis Medical Centre Brits, South Africa, 0250 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Lüdenscheid- Untern.verb. Märkische Kliniken GmbH Lüdenscheid, Germany, 58515 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General San Jorge Huesca, Spain, 22004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edith Wolfson Medical Center Holon, Israel, 58100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ziekenhuis St. Jansdal HARDERWIJK, Netherlands, 3844 DG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Saint Joseph - Paris PARIS, France, 75014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Juárez de México SS México, D.F., Mexico, 07760 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hydromed Hospital Bloemfontein Bloemfontein, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital del Mar Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hull Royal Infirmary Hull, United Kingdom, HU3 2JZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Nacional de Enfermedades Respiratorias SS México, D.F., Mexico, 14080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny im. M. Kopernika Gdansk, Poland, 80-803 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Augusta-Kranken-Anstalt GmbH Bochum, Germany, 44791 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Moncloa Madrid, Spain, 28008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Charite zu Berlin Berlin, Germany, 10117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Général - Aix en Provence AIX-EN-PROVENCE, France, 13616 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier de la Durance - Avignon AVIGNON, France, 84000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kujawsko-Pomorskie Centrum Pulmunologii Bydgoszcz, Poland, 85-326 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vergelegen Medi-Clinic Somerset West, South Africa, 7130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Principe de Asturias Alcalá de Henares, Spain, 28805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Western General Hospital Edinburgh, United Kingdom, EH4 2XU | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SP Szpital Kliniczny nr 5 Wroclaw, Poland, 50-417 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Font Pré - Toulon TOULON, France, 83056 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of the Free State Bloemfontein, South Africa, 9300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Victor Dupuy - Argenteuil ARGENTEUIL, France, 95107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Général - Agen AGEN, France, 47923 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multinational, prospective, randomized, double-blind study to investigate the efficacy and safety of sequential intravenous/oral moxifloxacin in comparison to intravenous levofloxacin plus intravenous ceftriaxone followed by oral levofloxacin, in the treatment of patients with severe community-acquired pneumonia
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Clinical responseTimeframe: 5 to 7 days after last dose of study medication
Secondary Outcome
- Clinical and bacteriological responseTimeframe: At the day of switch from intravenous to oral therapy
- Clinical and bacteriological response on treatmentTimeframe: At day 3 to 5
- Clinical and bacteriological responseTimeframe: At the end of treatment
- Bacteriological responseTimeframe: 5-7 days after end of treatment
- Mortality attributable to pneumoniaTimeframe: 5-7 days after end of treatment
- Clinical and bacteriological responseTimeframe: At days 21 to 28 after end of treatment
- Symptoms course of community-acquired pneumoniaTimeframe: at defined visits
- Adverse Event CollectionTimeframe: all visits
Additional Information
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