CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients

Completed

• Conditions: Pneumonia
• Interventions: Drug: Moxifloxacin (Avelox, BAY12-8039)

• Registration Number: NCT00987792
• Lead Sponsor: Bayer

Brief Summary

The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability.

As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Primary Completion: 2011-06
• Study Completion: 2012-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-06
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2595

Inclusion Criteria

• Adult hospitalized patients with a diagnosis of CAP (based on local medical practice) and decision taken by the investigator to treat with moxifloxacin and to start treatment with intravenous administration. The local moxifloxacin product information must be considered.

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Exclusion Criteria

• Contraindications stated in the local moxifloxacin product information; warnings and precautions must be considered.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Moxifloxacin (Avelox, BAY12-8039)	-

Primary Outcome Measures

Name	Time	Method
The primary objective is to evaluate the distribution of the CRB-65 severity index at baseline in hospitalized patients suffering from CAP and to whom moxifloxacin (starting with intravenous administration) was prescribed, in countries from South Eastern	At baseline only

Secondary Outcome Measures

Name	Time	Method
Assessment of use of different diagnostic measures in daily routine practice, especially chest radiography and microbiology	7-14 days
Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapy	7-14 days
Assessment of clinical signs and symptoms before and after therapy with moxifloxacin	7-14 days
Measurement of moxifloxacin treatment success in terms of effectiveness and outcome	7-14 days
Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients	7-14 days