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

Study Overview
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Brief Summary
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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.

Official Title
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A National, Prospective, Randomized, Open Label Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin vs IV Ceftriaxone + IV Azithromycin Followed by PO Amoxicilline/Clavulanate and PO Clarithromycin in Subjects With Community-acquired Pneumonia

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: Avelox (Moxifloxacin, BAY12-8039)
* Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Avelox (Moxifloxacin, BAY12-8039)<br>* IV therapy: every 24 hours, patients will be administered a 400 mg moxifloxacin infusion over 60 minutes. Oral therapy: patients will be administered a single moxifloxacin 400 mg tablet, every 24 hours<br>|
| Active Comparator: Arm 2<br> | Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin<br>* IV therapy: every 24 hours patients will be administered a 2 g ceftriaxone infusion over 30 minutes. Following the infusion with ceftriaxone, patients will be administered a 500 mg azithromycin infusion over 180 minutes.Oral therapy: every 8 hours patients will be administered a 1000 mg amoxicillin/clavulanic acid tablet. Every 12 hours patients will be administered a 500 mg clarithromycin tablet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and bacteriological response on the day of switch from IV to oral therapy |  | Day of switch from IV to oral therapy | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAP, Community-acquired pneumonia