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Efficacy and Safety Evaluation of Fixed Dose Combination of Cefepime and Amikacin in Comparison with Cefepime Alone in Treatment of Nosocomial Pneumonia Patients

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Nosocomial pneumonia is the most frequent and leading cause of morbidity and mortality. Pseudomonas aeruginosa the most frequent causative agent is intrinsically resistant to most antibiotics. The study was aimed at comparing the efficacy and safety of fixed dose combination (FDC) of Cefepime and Amikacin with that of Cefepime alone in treatment of patients suffering from nosocomial pneumonia.

Patients (n=200) suffering from nosocomial pneumonia participated in an open labeled, two arm, randomized, comparative, multicentric trial. One group (n=100) of patients were treated with intravenous injection of Cefepime and Amikacin FDC 2.5 g b.i.d and other group (n=100) of patients were treated with intra-venous injection of Cefepime alone 2.0 g b.i.d, for 7-10 days. Outcome of therapy was evaluated on the basis of clinical and bacteriological evaluation.

Clinical and bacteriological successful outcomes were significantly higher in the patients treated with Cefepime and Amikacin FDC than Cefepime alone treated patients. Analysis of patients infected with Pseudomonas aeruoginosa amongst the two treatment arms indicated that clinical and bacteriological success rate is significantly higher in Cefepime and Amikacin FDC treated patients than Cefepime alone treated group. No major adverse events were observed in both the treatment arms.

In conclusion, fixed dose combination of Cefepime and Amikacin was more effective in the treatment of nosocomial pneumonia than Cefepime alone.
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Keywords: Amikacin; Cefepime; Nosocomial pneumonia; P. aeruginosa; synergistic

Document Type: Research Article

Publication date: May 1, 2008

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  • Current Clinical Pharmacology publishes frontier reviews on all the latest advances in clinical pharmacology. The journal's aim is to publish the highest quality review articles in the field. Topics covered include: pharmacokinetics; therapeutic trials; adverse drug reactions; drug interactions; drug metabolism; pharmacoepidemiology; and drug development. The journal is essential reading for all researchers in clinical pharmacology.
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