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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00987792
First received: September 30, 2009
Last updated: August 5, 2014
Last verified: August 2014
  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
Pneumonia
Drug: Moxifloxacin (Avelox, BAY12-8039)

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

Resource links provided by NLM:


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 ]

Enrollment: 2595
Study Start Date: September 2009
Study Completion Date: October 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Moxifloxacin (Avelox, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Croatia
Many Locations, Croatia
France
Many Locations, France
Hungary
Many Locations, Hungary
Jordan
Many Locations, Jordan
Kazakhstan
Many Locations, Kazakhstan
Lebanon
Many Locations, Lebanon
Macedonia, The Former Yugoslav Republic of
Many Locations, Macedonia, The Former Yugoslav Republic of
Moldova, Republic of
Many Locations, Moldova, Republic of
Romania
Many Locations, Romania
Russian Federation
Many Locations, Russian Federation
Ukraine
Many Locations, Ukraine
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00987792     History of Changes
Other Study ID Numbers: 14522, AX0801
Study First Received: September 30, 2009
Last Updated: August 5, 2014
Health Authority: Kazakhstan: Ethical Commission
Macedonia: Ministry of Health
Moldova: Ministry of Health
Croatia: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
France: National Council of Physicians (CNOM)

Keywords provided by Bayer:
Community Acquired Pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014