Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00987792

Purpose

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.

Condition	Intervention	Phase
Bronchitis, Chronic Bronchial Diseases	Drug: Avelox (Moxifloxacin, BAY12-8039)	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients

Resource links provided by NLM:

MedlinePlus related topics: Bronchitis Pneumonia

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

n.a

Estimated Enrollment:	2655
Study Start Date:	September 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: Avelox (Moxifloxacin, BAY12-8039) Hospitalized patients receiving Avelox according to local drug information

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987792

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Croatia
	Recruiting
Many Locations, Croatia
Kazakhstan
	Not yet recruiting
Many Locations, Kazakhstan
Macedonia, The Former Yugoslav Republic of
	Not yet recruiting
Many Locations, Macedonia, The Former Yugoslav Republic of
Moldova, Republic of
	Not yet recruiting
Many Locations, Moldova, Republic of
Romania
	Not yet recruiting
Many Locations, Romania
Russian Federation
	Not yet recruiting
Many Locations, Russian Federation
Ukraine
	Not yet recruiting
Many Locations, Ukraine

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer HealthCare AG ( Global Medical Affairs Therapeutic Area Head )
Study ID Numbers:	14522, AX0801, CAPRIVI
Study First Received:	September 30, 2009
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00987792 History of Changes
Health Authority:	Kazakhstan: Ethical Commission; Macedonia: Ministry of Health; Moldova: Ministry of Health; Croatia: Central Ethics Committee

Keywords provided by Bayer:

Acute Exacerbation of Chronic Bronchitis

Additional relevant MeSH terms:

Anti-Infective Agents
Bronchial Diseases
Pharmacologic Actions
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections

Moxifloxacin
Lung Diseases
Therapeutic Uses
Bronchitis
Pneumonia
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 09, 2010