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

Condition(s) targeted: Community-Acquired Pneumonia

Intervention: Avelox (Moxifloxacin, BAY12-8039) (Drug); Comparator (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Clinical response

Secondary outcome:

Clinical and bacteriological response

Clinical and bacteriological response on treatment

Clinical and bacteriological response

Bacteriological response

Mortality attributable to pneumonia

Clinical and bacteriological response

Symptoms course of community-acquired pneumonia

Safety

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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) AND/OR

- 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 AND

- 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 consolidation AND

- 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

Bruxelles 1070, Belgium

NAMUR 5000, Belgium

LEUVEN 3000, Belgium

Santiago de Chile, Chile

Santiago, Chile

Bogotá, Colombia

Santafe de Bogota, Colombia

Bucaramanga, Colombia

SAINT-GAUDENS 31806, France

BORDEAUX 33000, France

BELFORT 90016, France

TOULON 83056, France

ARGENTEUIL 95107, France

AVIGNON 84000, France

Athens 11527, Greece

Thessaloniki 546 36, Greece

Tel Aviv 64239, Israel

Afula 18101, Israel

Ashkelon 78306, Israel

Tel Hashomer 52621, Israel

Vilnius LT-2001, Lithuania

Vilnius LT-2006, Lithuania

Kaunas 47144, Lithuania

Kaunas 45130, Lithuania

México, D.F. 07760, Mexico

México, D.F. 14080, Mexico

EDE 6716 RP, Netherlands

DEN BOSCH 5211 RB, Netherlands

HEERLEN 6419 PC, Netherlands

Lima Cercado LIMA 1, Peru

Callao 02, Peru

Lima 01, Peru

Warszawa 00-909, Poland

Warszawa 01-138, Poland

Krakow 30-501, Poland

Wroclaw 50-417, Poland

Gdansk 80-803, Poland

Barcelona 08036, Spain

Barcelona 08003, Spain

Guadalajara 19002, Spain

Madrid 28008, Spain

Valencia 46014, Spain

Jönköping 551 85, Sweden

Karlstad 651 85, Sweden

Huesca, Aragón 22004, Spain

L'Hospitalet de Llobregat, Barcelona 08907, Spain

Berlin, Berlin / 285 13353, Germany

Vicente López, Buenos Aires B1602DOH, Argentina

Buenos Aires, Capital Federal C1120AAF, Argentina

Buenos Aires, Capital Federal C1431FWO, Argentina

Buenos Aires, Capital Federal C1180AAX, Argentina

Middlesborough, Cleveland TS4 3BW, United Kingdom

Dumfries, Dumfries and Galloway DG1 4EP, United Kingdom

Toluca, Edo. de México 50130, Mexico

Bloemfontein, Free State, South Africa

Pretoria, Gauteng 0083, South Africa

Johannesburg, Gauteng 2132, South Africa

Brits, Gauteng 0250, South Africa

Guadalajara, Jalisco 44280, Mexico

Alcalá de Henares, Madrid 28805, Spain

EINDHOVEN, Noord Brabant 5623 EJ, Netherlands

Paderborn, Nordrhein-Westfalen / 347 33098, Germany

Monterrey, Nuevo León 64460, Mexico

Rio, Patras 265 00, Greece

Halle, Sachsen-Anhalt / 311 06112, Germany

Newcastle Upon Tyne, Tyne and Wear NE7 7DN, United Kingdom

Viña del Mar, V Region, Chile

Somerset West, Western Cape 7130, South Africa

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Starting date: January 2004
Ending date: July 2005
Last updated: April 29, 2008