CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00987792
First received: September 30, 2009
Last updated: October 30, 2012
Last verified: October 2012
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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: | 2504 |
| Study Start Date: | September 2009 |
| Study Completion Date: | June 2011 |
| 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
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:
No publications provided
| Responsible Party: | Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00987792 History of Changes |
| Other Study ID Numbers: | 14522, AX0801 |
| Study First Received: | September 30, 2009 |
| Last Updated: | October 30, 2012 |
| Health Authority: | Kazakhstan: Ethical Commission Macedonia: Ministry of Health Moldavia: 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-Infective Agents Therapeutic Uses |
Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013