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

Phase 3

Completed

• Conditions: Pneumonia
• Interventions: Drug: Avelox (Moxifloxacin, BAY12-8039); Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin

• Registration Number: NCT00717561
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-17
• Primary Completion: 2009-05
• Study Completion: 2009-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-11-02
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Avelox (Moxifloxacin, BAY12-8039)	-
Arm 2	Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin	-

Primary Outcome Measures

Name	Time	Method
Clinical response 20 days after completion of study treatment (Test-of-Cure visit)	20 days after last dose of study drug (TOC Visit)

Secondary Outcome Measures

Name	Time	Method
Clinical and bacteriological response on treatment Day 3-5 (if the day of switch is different from Day 3, 4 or 5)	Day 3-5
Bacteriological response at TOC	20 days after last dose of study drug
Clinical and bacteriological response at the end of treatment	Day 7-14 after first dose of study drug
Mortality attributable to pneumonia at the Test-of-Cure visit	20 days after last dose of study drug
Clinical and bacteriological response on the day of switch from IV to oral therapy	Day of switch from IV to oral therapy