Cefixime with enhanced solubility, a better alternative in management of Typhoid fever: A randomized controlled clinical study

摘要

ABSTRACT Cefixime has bioavailability of 40-50%, which could be attributed to its low solubility in GI tract. The objective of this pilot study was to compare the efficacy and safety of improved formulation of cefixime 200 mg tablet (CEFOLAC) versus conventional marketed cefixime 200 mg tablet in patients with typhoid fever (TF). Patients with clinical diagnosis of TF were randomized to receive either treatment twice daily for 10 days. Primary efficacy end point was reduction of clinical symptoms score on day 5 and number of patients with absence of clinical symptoms. Secondary endpoints include microbiological cure and clinical relapse on day 10 and 21. Total 22 patients completed study successfully and were subjected to analysis. Percentage improvement in total clinical symptoms score from baseline to day 5 was greater in improved formulation of cefixime (70 %) than conventional cefixime 200 mg tablet (58 %). On day 5, numbers of patients with complete cure of clinical symptoms were greater in group A as compared to group B. All patients in both the groups were cured based on clinical symptoms and microbiological evaluation on day 10 and day 21. No case of clinical relapse was observed. Both the formulations of cefixime were well tolerated by patients. Improved formulation of cefixime offers faster and greater improvement in clinical symptoms than conventional cefixime tablet in patients with TF. Improved formulation of cefixime is a better option for the treatment of patients with TF than conventional cefixime tablet. Keyword: Typhoid fever, Cefixime, Bioavailability, Solubility