A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired pneumonia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Ceftriaxone; Clarithromycin; Clavulanic Acid; Clavulanic Acids; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Hospitalized non-ICU patients (age, >= 18 years)

• Clinical signs and symptoms of CAP, with PSI score IV or V

• Radiologically confirmed evidence of a new and/or progressive infiltrate(s)

• Requirement for initial parenteral therapy

• At least 2 of the following conditions:

• Productive or non productive cough with or without purulent or mucosus or mucopurulent sputum

• Dyspnea and/or tachypnea (respiratory rate of > 20 breaths/min)

• Rigors and/or chills

• Pleuritic chest pain

• Auscultatory findings of rales and/or crackles on pulmonary examination and/or evidence of pulmonary consolidation

• Fever (an oral temperature of >= 38 °C, a rectal temperature of >= 39 °C, or a tympanic temperature of >= 38.5 °C) or hypothermia (rectal or core temperature of < 35 °C), and a WBC count of >= 10,000 cells/mm3 or >= 15% immature neutrophils bands; regardless of peripheral WBC count) or leukopenia (total WBC count of < 4500 cells/mm3)

• Written informed consent

Exclusion Criteria:

• PSI Class I-III and V with need for ICU admission

• Hospitalization for > 48 hours before developing pneumonia, or discharge from hospital < 30 days prior. Note: patients currently residing in residential long-term facilities can be enrolled in the study