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

Status and phase

Completed

Phase 3

Conditions

Pneumonia

Treatments

Drug: Avelox (Moxifloxacin, BAY12-8039)

Drug: Levofloxacin + Ceftriaxone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00431678

11215 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

738 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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