Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI)

BMC Pulmonary Medicine

Thomas Petri³  Hans-Peter Marschall¹  Liudmyla Iudina⁴  László Rókusz⁶  Irena Kondova Topuzovska⁵  Alexandr Bezlepko²  Ilija Kuzman⁷ 

[1] Bayer Vital GmbH, Leverkusen, Germany;Military Clinical Hospital N. Burdenko, Moscow, Russia;Bayer Pharma AG, Berlin, Germany;Pulmonology Department, National Medical Academy of Postgraduate Education, City Clinic #17, Kiev, Ukraine;University Clinic for Infectious Diseases, Medical Faculty, Skopje, Macedonia;1st Department of Medicine, Military Hospital, Hungarian Defence Forces (Previously 1st Department of Medicine, National Healthcare Centre), Budapest, Hungary;University of Zagreb School of Medicine, University Hospital for Infectious Diseases “Dr. Fran Mihaljević”, Mirogojska cesta 8, 10000 Zagreb, Croatia

关键词: Moxifloxacin;    CAP;    Community acquired;    Pneumonia;    Antibiotics;   

Others  :  862756
DOI  :  10.1186/1471-2466-14-105

 received in 2014-02-19, accepted in 2014-06-18,  发布年份 2014

【 摘 要 】

Background

Community acquired pneumonia (CAP) is a major cause of morbidity, hospitalization, and mortality worldwide. Management of CAP for many patients requires rapid initiation of empirical antibiotic treatment, based on the spectrum of activity of available antimicrobial agents and evidence on local antibiotic resistance. Few data exist on the severity profile and treatment of hospitalized CAP patients in Eastern and Central Europe and the Middle East, in particular on use of moxifloxacin (Avelox®), which is approved in these regions.

Methods

CAPRIVI (Community Acquired Pneumonia: tReatment wIth AVelox® in hospItalized patients) was a prospective observational study in 12 countries: Croatia, France, Hungary, Kazakhstan, Jordan, Kyrgyzstan, Lebanon, Republic of Moldova, Romania, Russia, Ukraine, and Macedonia. Patients aged >18 years were treated with moxifloxacin 400 mg daily following hospitalization with a CAP diagnosis. In addition to efficacy and safety outcomes, data were collected on patient history and disease severity measured by CRB-65 score.

Results

2733 patients were enrolled. A low severity index (i.e., CRB-65 score <2) was reported in 87.5% of CAP patients assessed (n = 1847), an unexpectedly high proportion for hospitalized patients. Moxifloxacin administered for a mean of 10.0 days (range: 2.0 to 39.0 days) was highly effective: 96.7% of patients in the efficacy population (n = 2152) improved and 93.2% were cured of infection during the study. Severity of infection changed from “moderate” or “severe” in 91.8% of patients at baseline to “no infection” or “mild” in 95.5% at last visit. In the safety population (n = 2595), 127 (4.9%) patients had treatment-emergent adverse events (TEAEs) and 40 (1.54%) patients had serious TEAEs; none of these 40 patients died. The safety results were consistent with the known profile of moxifloxacin.

Conclusions

The efficacy and safety profiles of moxifloxacin at the recommended dose of 400 mg daily are characterized in this large observational study of hospitalized CAP patients from Eastern and Central Europe and the Middle East. The high response rate in this study, which included patients with a range of disease severities, suggests that treatment with broader-spectrum drugs such as moxifloxacin is appropriate for patients with CAP who are managed in hospital.

Trial registration

ClinicalTrials.gov identifier: NCT00987792

【 授权许可】

   
2014 Kuzman et al.; licensee BioMed Central Ltd.

【 图 表 】

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