Efficacy and Safety of Fixed Dose Combination of Cefpodoxime Proxetil and Potassium Clavulanate (Cefchamp) in Comparison with Cefuroxime Axetil in Patients with Lower Respiratory Tract Infections.

ABSTRACT

Objectives: To evaluate the efficacy and safety of Fixed Dose Combination of Cefpodoxime Proxetil and Potassium Clavulanate (Cefchamp) in comparison with Cefuroxime Axetil in patients with Lower Respiratory Tract Infections.Methods:In this open, randomized, and controlled, parallel-group study of 7 days, 57 patients of both gender above 18 years of age with diagnosis of lower respiratory tract infection were randomized to receive Fixed Dose Combination (FDC) of Cefpodoxime Proxetil plus Potassium Clavulanate (Cefchamp), or Cefuroxime Axetil (CA) for a period of 7 days. Efficacy was assessed by symptoms of cough, dyspnoea, wheezing, Rhonchi, and chest pain based on 4-point scale as 0=none,1=mild, 2=moderate, 3=severe. Fever was recorded as the patient’s actual temperature. Safety assessment included adverse events and adverse drug reactions during the study period.Results: Three patients lost to follow up with CA.The improvement in all symptoms except cough was greater with CC as compared to CA group(p, >0.05). Fever improved from 37.18°C at baseline to 37.01 on day 3 with CC, whereas with CA the fever improved from 37.l5 at baseline to 37.05 on day 3 with CA. Fever subsided in all the patients in both treatments by day 5 of study therapy. Clinical cure was seen in 57.14% (16/28) patients on CC, whereas 42.3% patients (11/26) on CA had clinical cure.Conclusions:The fixed dose combination of Cefpodoxime Proxetil 200 mg and Potassium Clavulanate 125mg (Cefchamp) in comparison with Cefuroxime Axetil 500 mg showed improvement in the cure of respiratory tract infections in terms of decreasing the patient’s LRTI symptoms, improving the patient’s general health and with few adverse events and adverse drug reactions. However, further studies of greater sample size and blinded nature are needed to further substantiate this effect.