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

Information source: Bayer
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchitis, Chronic; Bronchial Diseases

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

Phase: N/A

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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

Secondary outcome:

Assessment of use of different diagnostic measures in daily routine practice, especially chest radiography and microbiology

Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapy

Assessment of clinical signs and symptoms before and after therapy with moxifloxacin

Measurement of moxifloxacin treatment success in terms of effectiveness and outcome

Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Many Locations, Croatia; Recruiting

Many Locations, Hungary; Recruiting

Many Locations, Jordan; Recruiting

Many Locations, Kazakhstan; Recruiting

Many Locations, Macedonia, The Former Yugoslav Republic of; Recruiting

Many Locations, Moldova, Republic of; Not yet recruiting

Many locations, Romania; Not yet recruiting

Many locations, Russian Federation; Recruiting

Many locations, Ukraine; Recruiting

Additional Information

Click here and search for drug information provided by the FDA.

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

Click here to find results for studies related to marketed products.

Starting date: September 2009
Last updated: September 10, 2010

Page last updated: October 04, 2010

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