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
NCT ID: NCT00431678
Last Updated: 2014-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
738 participants
INTERVENTIONAL
2004-01-31
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Avelox (Moxifloxacin, BAY12-8039)
Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039)
Arm 2
Levofloxacin + Ceftriaxone
Intravenous combination therapy of levofloxacin 500 mg twice daily and ceftriaxone (2 g once a day) followed by oral levofloxacin (500 mg twice a day for 7 to 14 days).
Interventions
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Avelox (Moxifloxacin, BAY12-8039)
Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039)
Levofloxacin + Ceftriaxone
Intravenous combination therapy of levofloxacin 500 mg twice daily and ceftriaxone (2 g once a day) followed by oral levofloxacin (500 mg twice a day for 7 to 14 days).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Vicente López, Buenos Aires, Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Leuven, , Belgium
Liège, , Belgium
Namur, , Belgium
Temuco, Región de la Araucanía, Chile
Viña del Mar, Región de Valparaíso, Chile
Santiago, , Chile
Bogotá, , Colombia
Bucaramanga, , Colombia
Agen, , France
Aix-en-Provence, , France
Argenteuil, , France
Avignon, , France
Belfort, , France
Bordeaux, , France
Brive-la-Gaillarde, , France
Paris, , France
Saint-Gaudens, , France
Toulon, , France
Vesoul, , France
Bochum, North Rhine-Westphalia, Germany
Bochum, North Rhine-Westphalia, Germany
Lüdenscheid, North Rhine-Westphalia, Germany
Paderborn, North Rhine-Westphalia, Germany
Halle, Saxony-Anhalt, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Rio, Patras, Greece
Thessaloniki, Thessaloniki, Greece
Athens, , Greece
Afula, Israel, Israel
Ashkelon, Israel, Israel
Holon, Israel, Israel
Tel Aviv, Israel, Israel
Tel Litwinsky, , Israel
Kaunas, , Lithuania
Kaunas, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Toluca, Edo. de México, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
México, D.F., , Mexico
México, D.F., , Mexico
México, D.F., , Mexico
México, D.F., , Mexico
Eindhoven, North Brabant, Netherlands
's-Hertogenbosch, , Netherlands
Ede, , Netherlands
Harderwijk, , Netherlands
Heerlen, , Netherlands
Callao, , Peru
Lima, , Peru
Lima Cercado, , Peru
Bydgoszcz, , Poland
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Lisbon, , Portugal
Bloemfontein, Free State, South Africa
Bloemfontein, Freestate, South Africa
Brits, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Huesca, Aragon, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Guadalajara, Guadalajara, Spain
Alcalá de Henares, Madrid, Spain
Madrid, Madrid, Spain
Valencia, Valencia, Spain
Jönköping, , Sweden
Kalmar, , Sweden
Karlstad, , Sweden
Skövde, , Sweden
Middlesbrough, Cleveland, United Kingdom
Dumfries, Dumfries and Galloway, United Kingdom
Hull, Humberside, United Kingdom
Edinburgh, Lothian, United Kingdom
Rotherham, South Yorkshire, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Countries
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References
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Torres A, Garau J, Arvis P, Carlet J, Choudhri S, Kureishi A, Le Berre MA, Lode H, Winter J, Read RC; MOTIV (MOxifloxacin Treatment IV) Study Group. Moxifloxacin monotherapy is effective in hospitalized patients with community-acquired pneumonia: the MOTIV study--a randomized clinical trial. Clin Infect Dis. 2008 May 15;46(10):1499-509. doi: 10.1086/587519.
Other Identifiers
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11215
Identifier Type: -
Identifier Source: org_study_id