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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Avelox (Moxifloxacin, BAY12-8039)
  • Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039)
• Drug: Comparator
  • 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).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • N/A
• Active Comparator: Arm 2
  • N/A

Primary Measures

• Clinical response
  • Time Frame: 5 to 7 days after last dose of study medication
    

Secondary Measures

• Clinical and bacteriological response
  • Time Frame: At the day of switch from intravenous to oral therapy
    
• Clinical and bacteriological response on treatment
  • Time Frame: At day 3 to 5
    
• Clinical and bacteriological response
  • Time Frame: At the end of treatment
    
• Bacteriological response
  • Time Frame: 5-7 days after end of treatment
    
• Mortality attributable to pneumonia
  • Time Frame: 5-7 days after end of treatment
    
• Clinical and bacteriological response
  • Time Frame: At days 21 to 28 after end of treatment
    
• Symptoms course of community-acquired pneumonia
  • Time Frame: at defined visits
    
• Safety
  • Time Frame: all visits
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00431678

Study ID Number: 11215

ClinicalTrials.gov Identifier: NCT00431678

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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