Evaluation of Efficacy and Safety of Fixed Dose Combination of Ceftazidime-Tobramycin in Comparison with Ceftazidime in Lower Respiratory Tract Infections
Manu Chaudhary, Sanjay Mohan Shrivastava and Rajesh Sehgal
Affiliation: Venus Medicine Research Centre, Venus Remedies limited, Hill Top, Industrial Estate, Jharmajri EPIP, Phase I(extn) Bhatoli Kalan, Baddi (H.P.) 173205, India.
Keywords: Ceftazidime, tobramycin, P. aeruginosa, LRTI
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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