A Randomized Study of Sequential Intravenous/Oral Moxifloxacin in Comparison to Sequential Intravenous Ceftriaxone/Oral Cefuroxime Axetil in Patients with Hospital-Acquired Pneumonia |
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Authors: | G Höffken J Barth E Rubinstein H Beckmann for the HAP study group |
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Institution: | (1) Pulmonology, Medical Clinic 1, University Clinic Carl Gustav Carus, Fetscherstr. 74, D-01309 Dresden, Germany;(2) Dept. of Internal Medicine, BG Clinic Bergmannstrost, Halle/Saale, Germany;(3) Infectious Diseases Service, University of Manitoba, Winnipeg, MB, Canada;(4) Bayer Vital GmbH, Leverkusen, Germany |
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Abstract: | Abstract
Background: Empiric treatment of hospital-acquired pneumonia (HAP) should be focused on the suspected pathogens. We evaluated the efficacy
and safety of moxifloxacin vs ceftriaxone in patients with HAP without risk of infections with Pseudomonas aeruginosa and other non-fermentative Gram-negative bacteria.
Patients and Methods: We performed a prospective, randomized, non-blind, multicentric and multinational study to compare the efficacy and safety
of moxifloxacin 400 mg IV once daily followed by oral moxifloxacin 400 mg once daily to ceftriaxone 2 g IV once daily followed
by oral cefuroxime axetil 500 mg twice daily to treat mild-to-moderate HAP in adult patients requiring initial parenteral
therapy. The primary efficacy variable was clinical response 7–10 days after the end of a 7–14-day treatment period, secondary
endpoints included clinical and bacteriologic response at different intervals for up to 31 days after treatment. The trial
was terminated prematurely due to slow patient recruitment.
Results: A total of 161 subjects (87 men, 74 women) between 18 and 95 years of age were enrolled, 120 of whom were eligible for per
protocol efficacy analyses (60 each in the moxifloxacin and the comparator groups). Clinical success rates were 87% for moxifloxacin
and 83% for the comparator 95% CI (–9.77 to 15.96%)]. The results for secondary endpoints were comparable between groups.
Both treatments were safe and well tolerated.
Conclusion: Moxifloxacin IV/oral can be considered as a possible alternative for the antibiotic treatment of patients with mild-to-moderate
nosocomial pneumonia without risk factors for highly resistant microorganisms. |
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