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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00987792
Recruitment Status : Completed
First Posted : October 1, 2009
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date September 30, 2009
First Posted Date October 1, 2009
Last Update Posted Date August 7, 2015
Study Start Date September 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00987792 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (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 ]
  • Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapy [ Time Frame: 7-14 days ]
  • Assessment of clinical signs and symptoms before and after therapy with moxifloxacin [ Time Frame: 7-14 days ]
  • Measurement of moxifloxacin treatment success in terms of effectiveness and outcome [ Time Frame: 7-14 days ]
  • Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients [ Time Frame: 7-14 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients
Official Title CAPRIVI: 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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Female and male hospitalized adult patients scheduled to be treated with moxifloxacin for their CAP and starting treatment with intravenous administration will be documented after the attending physician made the therapeutic decision at his/her discretion.
Condition Pneumonia
Intervention Drug: Moxifloxacin (Avelox, BAY12-8039)
Hospitalized patients receiving Avelox according to local drug information
Study Groups/Cohorts Group 1
Intervention: Drug: Moxifloxacin (Avelox, BAY12-8039)
Publications * Kuzman I, Bezlepko A, Kondova Topuzovska I, Rókusz L, Iudina L, Marschall HP, Petri T. Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI). BMC Pulm Med. 2014 Jun 30;14:105. doi: 10.1186/1471-2466-14-105.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 2, 2013)
2595
Original Estimated Enrollment
 (submitted: September 30, 2009)
2655
Actual Study Completion Date October 2012
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kazakhstan,   Croatia,   France,   Hungary,   Jordan,   Lebanon,   Macedonia, The Former Yugoslav Republic of,   Moldova, Republic of,   Romania,   Russian Federation,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number NCT00987792
Other Study ID Numbers 14522
AX0801 ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date August 2015