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

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00987792

First received: September 30, 2009

Last updated: October 30, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 30, 2009

Last Updated Date

October 30, 2012

Start Date ^ICMJE

September 2009

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00987792 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Pneumonia

Intervention ^ICMJE

Drug: Moxifloxacin (Avelox, BAY12-8039)

Hospitalized patients receiving Avelox according to local drug information

Study Group/Cohort (s)

Group 1

Intervention: Drug: Moxifloxacin (Avelox, BAY12-8039)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2504

Completion Date

June 2011

Primary Completion Date

Not Provided

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00987792

Other Study ID Numbers ^ICMJE

14522, AX0801

Has Data Monitoring Committee

Responsible Party

Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

October 2012

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

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