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

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.