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:

NCT00431678

EudraCT Number:

Not Available

Study Completed

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
738
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Brüderkrankenhaus St. Josef

Paderborn, Germany, 33098

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

University General Hospital of Patras

Rio, Greece, 265 04

Status
Completed
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Vilnius Center University Hospital

Vilnius, Lithuania, LT-2001

Status
Completed
 
Locations

Catharina Ziekenhuis

EINDHOVEN, Netherlands, 5623 EJ

Status
Completed
 
Locations

Hospital Nacional Arzobispo Loayza

Lima Cercado, Peru, LIMA 1

Status
Completed
 
Locations

Wojskowy Instytut Medyczny

Warszawa, Poland, 00-909

Status
Completed
 
Locations

Hospital Pulido Valente

Lisboa, Portugal, 1769-001

Status
Terminated
 
Locations

Länssjukhuset Ryhov

Jönköping, Sweden, 551 85

Status
Completed
 
Locations

Groote (new) Schuur Hospital

Cape Town, South Africa

Status
Terminated
 
Locations

Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno"

Buenos Aires, Argentina, C1431FWO

Status
Completed
 
Locations

Hospital Santa Clara

Santafé de Bogotá, Colombia

Status
Completed
 
Locations

Universitätsklinikum Otto-von Guericke - Magdeburg

Magdeburg, Germany, 39112

Status
Terminated
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Hospital de Clínicas "José de San Martín"

Buenos Aires, Argentina, C1120AAF

Status
Completed
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Hospital de Carabineros

Santiago de Chile, Chile

Status
Completed
 
Locations

Hospital Militar Central

Bogotá, Colombia

Status
Completed
 
Locations

Centre Hospitalier - Brive La Gaillarde

BRIVE-LA-GAILLARDE, France, 19100

Status
Terminated
 
Locations

Royal Hallamshire Hospital

Sheffield, United Kingdom, S10 2JF

Status
Terminated
 
Locations

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Mexico, 44280

Status
Completed
 
Locations

Clinique Sainte-Elisabeth

NAMUR, Belgium, 5000

Status
Completed
 
Locations

Hospital Dr. Sotero del Río

Santiago de Chile, Chile

Status
Completed
 
Locations

Centre Hospitalier - Saint Gaudens

SAINT-GAUDENS, France, 31806

Status
Completed
 
Locations

Hospital Daniel A. Carrión

Callao, Peru, 02

Status
Completed
 
Locations

Instytut Gruzlicy i Chorob Pluc

Warszawa, Poland, 01-138

Status
Completed
 
Locations

Meulmed Hospital Pretoria

Pretoria, South Africa, 0083

Status
Completed
 
Locations

Hospital General Universitario de Guadalajara

Guadalajara, Spain, 19002

Status
Completed
 
Locations

Hôpital Pellegrin Tripode - Bordeaux

BORDEAUX, France, 33000

Status
Completed
 
Locations

Dumfries & Galloway Royal Infirmary

Dumfries, United Kingdom, DG1 4EP

Status
Completed
 
Locations

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece, 546 36

Status
Completed
 
Locations

Haemek Medical Center

Afula, Israel, 18101

Status
Completed
 
Locations

Vilnius Mykolo Marcinkeviciaus Hospital

Vilnius, Lithuania, LT-2006

Status
Completed
 
Locations

Centro Médico Nacional "La Raza"

México, D.F., Mexico, 02290

Status
Terminated
 
Locations

Ziekenhuis Gelderse Vallei

EDE, Netherlands, 6716 RP

Status
Completed
 
Locations

Kärnsjukhuset

Skövde, Sweden, 541 85

Status
Terminated
 
Locations

Hospital Alemán

Buenos Aires, Argentina, C1118AAT

Status
Terminated
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Asistencia Pública Dr. Alejandro del Río

Santiago, Chile

Status
Completed
 
Locations

Instituto Neumológico de Oriente

Bucaramanga, Colombia

Status
Completed
 
Locations

Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Status
Completed
 
Locations

Rotherham District General Hospital

Rotherham, United Kingdom, S60 2UD

Status
Terminated
 
Locations

Sotiria General State Hospital of Chest Diseases

Athens, Greece, 11527

Status
Completed
 
Locations

The Barzilai Medical Center Ashkelon

Ashkelon, Israel, 78306

Status
Completed
 
Locations

Kaunas 2nd Clinical Hospital

Kaunas, Lithuania, 47144

Status
Completed
 
Locations

Uniwersytet Medyczny

Lodz, Poland, 91-425

Status
Terminated
 
Locations

Centralsjukhuset

Karlstad, Sweden, 651 85

Status
Completed
 
Locations

University of Witwatersrand

Johannesburg, South Africa, 2132

Status
Completed
 
Locations

Sanatorio Güemes

Buenos Aires, Argentina, C1180AAX

Status
Completed
 
Locations

Berufsgenossenschaftl. Kliniken Bergmannstrost

Halle, Germany, 06112

Status
Completed
 
Locations

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Status
Completed
 
Locations

Centre Hospitalier Général - Belfort

BELFORT, France, 90016

Status
Completed
 
Locations

Kaunas District Hospital

Kaunas, Lithuania, 45130

Status
Completed
 
Locations

Szpital Uniwersytecki CMUJ

Krakow, Poland, 30-501

Status
Completed
 
Locations

Hospital Zonal de Agudos Dr. Antonio Cetrángolo

Vicente López, Argentina, B1602DOH

Status
Completed
 
Locations

Hospital Regional De Temuco

Temuco, Chile

Status
Terminated
 
Locations

C.H.G. Paul Morel - Vesoul

VESOUL, France, 70014

Status
Terminated
 
Locations

James Cook University Hospital

Middlesborough, United Kingdom, TS4 3BW

Status
Completed
 
Locations

Hospital Nicolás San Juan

Toluca, Mexico, 50130

Status
Completed
 
Locations

Bfg Kliniken Bergmannsheil, Universitätsklinik

Bochum, Germany, 44789

Status
Terminated
 
Locations

Hospital General "Manuel Gea González"

México, D.F., Mexico, 14000

Status
Terminated
 
Locations

Jeroen Bosch Ziekenhuis, lokatie Groot Ziekengasthuis

DEN BOSCH, Netherlands, 5211 RB

Status
Completed
 
Locations

Hospital Dos de Mayo

Lima, Peru, 01

Status
Completed
 
Locations

CHU de Liège

LIEGE, Belgium, 4000

Status
Terminated
 
Locations

Hospital Gustavo Fricke

Viña del Mar, Chile

Status
Completed
 
Locations

Freeman Hospital

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 52621

Status
Completed
 
Locations

Hospital Universitario "José Eleuterio González"

Monterrey, Mexico, 64460

Status
Completed
 
Locations

Atrium Medisch Centrum

HEERLEN, Netherlands, 6419 PC

Status
Completed
 
Locations

Länssjukhuset

Kalmar, Sweden, 391 85

Status
Terminated
 
Locations

Private Practice Armansis Medical Centre

Brits, South Africa, 0250

Status
Completed
 
Locations

Klinikum Lüdenscheid- Untern.verb. Märkische Kliniken GmbH

Lüdenscheid, Germany, 58515

Status
Terminated
 
Locations

Hospital General San Jorge

Huesca, Spain, 22004

Status
Completed
 
Locations

Edith Wolfson Medical Center

Holon, Israel, 58100

Status
Terminated
 
Locations

Ziekenhuis St. Jansdal

HARDERWIJK, Netherlands, 3844 DG

Status
Terminated
 
Locations

Hôpital Saint Joseph - Paris

PARIS, France, 75014

Status
Terminated
 
Locations

Hospital Juárez de México SS

México, D.F., Mexico, 07760

Status
Completed
 
Locations

Hydromed Hospital Bloemfontein

Bloemfontein, South Africa

Status
Completed
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Completed
 
Locations

Hull Royal Infirmary

Hull, United Kingdom, HU3 2JZ

Status
Terminated
 
Locations

Instituto Nacional de Enfermedades Respiratorias SS

México, D.F., Mexico, 14080

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny im. M. Kopernika

Gdansk, Poland, 80-803

Status
Completed
 
Locations

Augusta-Kranken-Anstalt GmbH

Bochum, Germany, 44791

Status
Terminated
 
Locations

Clínica Moncloa

Madrid, Spain, 28008

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Terminated
 
Locations

Universitätsklinikum Charite zu Berlin

Berlin, Germany, 10117

Status
Terminated
 
Locations

Centre Hospitalier Général - Aix en Provence

AIX-EN-PROVENCE, France, 13616

Status
Terminated
 
Locations

Centre Hospitalier de la Durance - Avignon

AVIGNON, France, 84000

Status
Completed
 
Locations

Kujawsko-Pomorskie Centrum Pulmunologii

Bydgoszcz, Poland, 85-326

Status
Terminated
 
Locations

Vergelegen Medi-Clinic

Somerset West, South Africa, 7130

Status
Completed
 
Locations

Hospital Principe de Asturias

Alcalá de Henares, Spain, 28805

Status
Completed
 
Locations

Western General Hospital

Edinburgh, United Kingdom, EH4 2XU

Status
Terminated
 
Locations

SP Szpital Kliniczny nr 5

Wroclaw, Poland, 50-417

Status
Completed
 
Locations

Hôpital Font Pré - Toulon

TOULON, France, 83056

Status
Completed
 
Locations

University of the Free State

Bloemfontein, South Africa, 9300

Status
Terminated
 
Locations

Centre Hospitalier Victor Dupuy - Argenteuil

ARGENTEUIL, France, 95107

Status
Completed
 
Locations

Hopital Général - Agen

AGEN, France, 47923

Status
Terminated
 

Trial Design