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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00987792
First received: September 30, 2009
Last updated: August 5, 2014
Last verified: August 2014

September 30, 2009
August 5, 2014
September 2009
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00987792 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients
CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Pneumonia
Drug: Moxifloxacin (Avelox, BAY12-8039)
Hospitalized patients receiving Avelox according to local drug information
Group 1
Intervention: Drug: Moxifloxacin (Avelox, BAY12-8039)
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(1):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.
 
Completed
2595
October 2012
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Croatia,   France,   Hungary,   Jordan,   Kazakhstan,   Lebanon,   Macedonia, The Former Yugoslav Republic of,   Moldova, Republic of,   Romania,   Russian Federation,   Ukraine
 
NCT00987792
14522, AX0801
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP