Abstract
BackgroundCommunity 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.MethodsCAPRIVI (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.Results2733 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.ConclusionsThe 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 registrationClinicalTrials.gov identifier: NCT00987792
Highlights
Community acquired pneumonia (CAP) is a major cause of morbidity, hospitalization, and mortality worldwide
Patients and investigators Male or female patients aged 18 years and above who were hospitalized with a diagnosis of CAP were included in the study after the decision to prescribe moxifloxacin was made by treating physicians
The suspicion of fraud could not be rejected from the answers given during the telephone interview, e.g., because the patient files were not available to provide answers to prespecified questions
Summary
Community acquired pneumonia (CAP) is a major cause of morbidity, hospitalization, and mortality worldwide. 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. Community acquired pneumonia (CAP) is one of the most common infectious diseases worldwide [1]. Reported incidences of CAP in different countries range from 1.6 to 11 per 1000 adults, precise estimates are difficult to establish, in part because no universal definition exists for diagnosing CAP [2]. CAP is a major cause of morbidity, hospitalization, mortality, and impaired quality of life, and associated with substantial societal health care burden. Incidences of CAP and CAP-related mortality increase sharply with age, and are appreciably higher in men than women [9,11]
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