check_circleStudy Completed

Pneumonia

Bayer Identifier:

14522

ClinicalTrials.gov Identifier:

NCT00987792

EudraCT Number:

Not Available

EU CT Number:

Not Available
CAPRIVI: Community Acquired Pneumonia: Treatment with Avelox® in Hospitalized Patients

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A


  • - 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.


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

Trial summary

Enrollment Goal
2595
Trial Dates
September 2009 - October 2012
Phase
N/A
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Macedonia
Completed
Many Locations, Croatia
Completed
Many Locations, Moldova
Completed
Many Locations, Kazakhstan
Completed
Many Locations, Hungary
Completed
Many Locations, Russia
Completed
Many Locations, Ukraine
Completed
Many Locations, Romania
Completed
Many Locations, Jordan
Completed
Many Locations, Lebanon
Completed
Many Locations, France

Primary Outcome

  • 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
    date_rangeTime Frame:
    At baseline only
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Assessment of use of different diagnostic measures in daily routine practice, especially chest radiography and microbiology
    date_rangeTime Frame:
    7-14 days
    enhanced_encryption
    Safety Issue:
    No
  • Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapy
    date_rangeTime Frame:
    7-14 days
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of clinical signs and symptoms before and after therapy with moxifloxacin
    date_rangeTime Frame:
    7-14 days
    enhanced_encryption
    Safety Issue:
    No
  • Measurement of moxifloxacin treatment success in terms of effectiveness and outcome
    date_rangeTime Frame:
    7-14 days
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients
    date_rangeTime Frame:
    7-14 days
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

CAPRIVI: Community Acquired Pneumonia: Treatment with Avelox® in Hospitalized Patients
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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