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 Amakacin with that of Cefepime alone in treatment of patients suffering from nosocomial pneumonia. Patients 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 Amakacin FDC 2.5g b.i.d and other group (n=100) were treated with intravenous injection of Cefepime alone 2.0g 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 Amakacin FDC than Cefepime alone treated patients. Analysis of patients infected with Pseudomonas aeruginosa amongst the two treatment arms indicated that clinical and bacteriological success is significantly higher in Cefepime and Amakacin FDC treated patients than Cefepime alone treated group. No major adverse events with observed in both the treatment arms. In conclusion, fixed dose combination of Cefepime and Amakacin was more effective in the treatment of nosocomial pneumonia than Cefepime alone.

RCT Entities:   Population Interventions Outcomes