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


Tracking Information

Start Date  ICMJESeptember 2009
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: September 30, 2009)		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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00987792 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: September 30, 2009)
  • Assessment of use of different diagnostic measures in daily routine practice, especially chest radiography and microbiology [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapy [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Assessment of clinical signs and symptoms before and after therapy with moxifloxacin [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Measurement of moxifloxacin treatment success in terms of effectiveness and outcome [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients [ Time Frame: 7-14 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJECAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients
Official Title  ICMJECAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients
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 
Study Phase 
Study Type  ICMJEObservational
Study Design  ICMJECohort, Prospective
Condition  ICMJE
  • Bronchitis, Chronic
  • Bronchial Diseases
Intervention  ICMJEDrug: Avelox (Moxifloxacin, BAY12-8039)
Hospitalized patients receiving Avelox according to local drug information
Study Arms / Comparison GroupsGroup 1
Intervention: Drug: Avelox (Moxifloxacin, BAY12-8039)

Recruitment Information

Estimated Enrollment  ICMJE2655
Estimated Completion DateAugust 2010
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Bayer Clinical Trials Contactclinical-trials-contact@bayerhealthcare.com
Location Countries  ICMJECroatia,   Kazakhstan,   Macedonia, The Former Yugoslav Republic of,   Moldova, Republic of,   Romania,   Russian Federation,   Ukraine

Administrative Information

NCT ID  ICMJENCT00987792
Responsible PartyGlobal Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
Study ID Numbers  ICMJE14522, AX0801
Study Sponsor  ICMJEBayer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bayer Study DirectorBayer
Information Provided ByBayer