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OpenTrials
Completed

NCT Number: NCT00987792

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.

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Key information

Conditions

Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Croatia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moxifloxacin (Avelox, BAY12-8039)

Drug

Hospitalized patients receiving Avelox according to local drug information

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 7-14 days

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

    Time frame: 7-14 days

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

    Time frame: 7-14 days

  4. Measurement of moxifloxacin treatment success in terms of effectiveness and outcome

    Time frame: 7-14 days

  5. Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients

    Time frame: 7-14 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 1, 2009
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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