check_circleStudy Completed
Pneumonia
Bayer Identifier:
14522
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
CAPRIVI: Community Acquired Pneumonia: Treatment with Avelox® in Hospitalized Patients
Trial 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.
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
2595Trial Dates
September 2009 - October 2012Phase
N/ACould I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Macedonia | |
Completed | Many Locations, Croatia | |
Completed | Many Locations, Moldova | |
Completed | Many Locations, Kazakhstan | |
Completed | Many Locations, Hungary | |
Completed | Many Locations, Russia | |
Completed | Many Locations, Ukraine | |
Completed | Many Locations, Romania | |
Completed | Many Locations, Jordan | |
Completed | Many Locations, Lebanon | |
Completed | Many Locations, France |
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 Easterndate_rangeTime Frame:At baseline onlyenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Assessment of use of different diagnostic measures in daily routine practice, especially chest radiography and microbiologydate_rangeTime Frame:7-14 daysenhanced_encryptionNoSafety Issue:
- Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapydate_rangeTime Frame:7-14 daysenhanced_encryptionNoSafety Issue:
- Assessment of clinical signs and symptoms before and after therapy with moxifloxacindate_rangeTime Frame:7-14 daysenhanced_encryptionNoSafety Issue:
- Measurement of moxifloxacin treatment success in terms of effectiveness and outcomedate_rangeTime Frame:7-14 daysenhanced_encryptionNoSafety Issue:
- Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patientsdate_rangeTime Frame:7-14 daysenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A