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NCT00987792 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00987792
Other study ID # 14522
Secondary ID AX0801
Status Completed
Phase N/A
First received September 30, 2009
Last updated August 6, 2015
Start date September 2009
Est. completion date October 2012

Study information
Verified date August 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Kazakhstan: Ethical CommissionMacedonia: Ministry of HealthMoldova: Ministry of HealthCroatia: Ethics CommitteeRomania: National Medicines AgencyRussia: Ethics CommitteeFrance: National Council of Physicians (CNOM)
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2595
Est. completion date October 2012
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Moxifloxacin (Avelox, BAY12-8039)
Hospitalized patients receiving Avelox according to local drug information

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Croatia,  France,  Hungary,  Jordan,  Kazakhstan,  Lebanon,  Macedonia, The Former Yugoslav Republic of,  Moldova, Republic of,  Romania,  Russian Federation,  Ukraine, 

References & Publications (1)

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: 1 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 At baseline only No
Secondary Assessment of use of different diagnostic measures in daily routine practice, especially chest radiography and microbiology 7-14 days No
Secondary Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapy 7-14 days No
Secondary Assessment of clinical signs and symptoms before and after therapy with moxifloxacin 7-14 days No
Secondary Measurement of moxifloxacin treatment success in terms of effectiveness and outcome 7-14 days No
Secondary Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients 7-14 days Yes
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