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.
Problem statement:To develop a sensitive method to determine simultaneously ceftizidime and sulbactam in spiked plasma and combined formulation. Approach: In this study an isocratic High performance liquid chromatographic method with UV detection at 230 nm was described for simultaneous determination of Ceftazidime and sulbactam sodium in plasma and combined dosage form. Chromatographic separation of two drugs was achieved on a Hypersil ODS C-18 column using a mobile phase consisting of a binary mixture of acetonitrile and tetrabutyl ammonium hydroxide adjusted to pH 5.0 with orthophosphoric acid in ratio 25:75. Results: The developed performance liquid chromatographic method offers symmetric peak shape, good resolution and reasonable retention time for both drugs. Linearity, accuracy and precision were found to be acceptable over the concentration range of 125-625 ppm for Ceftazidime and 62.5-312.5 ppm for sulbactam sodium. Conclusion: The results showed that this method could be well used for the simultaneous estimation of Ceftazidime and Sulbactam in plasma and combined formulation.
Lower respiratory tract infections are major cause of morbidity and mortality. Objectives were to evaluate efficacy and safety of fixed dose combination (FDC) of Ceftazidime and Tobramycin in comparison with Ceftazidime alone in patients with lower respiratory tract infections. Patients (n=240) were randomly distributed in two arms: one arm was treated with Ceftazidime(1g)-Tobramycin(120mg) and other arm was treated with Ceftazidime (1g) alone. Patients were clinically, radiologically and bacteriologically evaluated. Clinically successful outcome was seen in 88.4% of the patients in Ceftazidime-Tobramycin treated group as compared to 61.2% in Ceftazidime alone treated group. In Ceftazidime-Tobramycin treated group, majority of pathogen isolated were H.inflenzae (35%), P. aeruginosa (24.16%), K. pneumoniae (16.66%) and M. catarrhalis (24.16%), whereas in Ceftazidime alone treated group majority of pathogen isolated were H.inflenzae (33.33%), P. aeruginosa (20%), K. pneumoniae (18.33%) and M. catarrhalis (28.33%). In Ceftazidime-Tobramycin treated group (98%), a significantly higher bacterial eradication was observed than Ceftazidime alone treated group (79%). Radiological improvement was also superior in Ceftazidime-Tobramycin treated group. No major adverse events were observed. Results showed that fixed dose combination of Ceftazidime Tobramycin is superior than Ceftazidime alone in the treatment of lower respiratory tract infections.
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