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Clinical Trials/NCT00987792
NCT00987792
Completed
Not Applicable

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

Bayer0 sites2,595 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Moxifloxacin (Avelox, BAY12-8039)
Conditions
Pneumonia
Sponsor
Bayer
Enrollment
2595
Primary Endpoint
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
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
October 2012
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bayer
Responsible Party
Sponsor

Eligibility Criteria

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.

Exclusion Criteria

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

Arms & Interventions

Group 1

Intervention: Moxifloxacin (Avelox, BAY12-8039)

Outcomes

Primary Outcomes

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

Time Frame: At baseline only

Secondary Outcomes

  • 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)

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