Clinical trial NCT00987792: CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients
Official title: CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: Community Acquired Pneumonia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-10-01
Enrollment: 2595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: At baseline only
Secondary outcomes:
measure: Assessment of use of different diagnostic measures in daily routine practice, especially chest radiography and microbiology
timeFrame: 7-14 days
measure: Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapy
timeFrame: 7-14 days
measure: Assessment of clinical signs and symptoms before and after therapy with moxifloxacin
timeFrame: 7-14 days
measure: Measurement of moxifloxacin treatment success in terms of effectiveness and outcome
timeFrame: 7-14 days
measure: Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients
timeFrame: 7-14 days
Other outcomes:
Locations:
city: Many Locations
country: Croatia
city: Many Locations
country: France
city: Many Locations
country: Hungary
city: Many Locations
country: Jordan
city: Many Locations
country: Kazakhstan
city: Many Locations
country: Lebanon
city: Many Locations
country: Macedonia, The Former Yugoslav Republic of
city: Many Locations
country: Moldova, Republic of
city: Many Locations
country: Romania
city: Many Locations
country: Russian Federation
city: Many Locations
country: Ukraine
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Kuzman I, Bezlepko A, Kondova Topuzovska I, Rokusz L, Iudina L, Marschall HP, Petri T. Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI). BMC Pulm Med. 2014 Jun 30;14:105. doi: 10.1186/1471-2466-14-105.