Open study on efficacy and tolerability of ciprofloxacin XR compared with ciprofloxacin BID in the treatment of typhoid fever.

ABSTRACT

AIM: To compare the efficacy and tolerability of ciproflaxin extended-release and ciproflaxin intermediate release in the treatment of typhoid fever. METHODS: A prospective, open labelled, clinical trial, comparing the safety and efficacy of extended-release ciprofloxacin 1000 mg once daily (Ciprofloxacin XR) and ciprofloxacin intermediate release 500 mg two times daily (Ciprofloxacin bid) was performed in adult with typhoid fever. Diagnosis for typhoid fever was based on Widal serology test, blood culture and Polymerase Chain Reaction (PCR) for Salmonella typhi. A two-sided student t-test and chi-square or Fisher's exact test were used for the analysis of clinical responses. RESULTS: Good clinical responses were obtained in 32 subjects (14 with Intermediate release ciprofloxacin and 18 with Extended-release ciprofloxacin) and there were no failure case (0%). Day to reach defervescence in Ciprofloxacin BID (mean 3.28 days) was similar to Ciprofloxacin XR group (mean 3.72 days) with p=0.43. Mild side effects were noted in 7.1% of subjects who received Ciprofloxacin BID compared by 22.2% in subjects who received Ciprofloxacin XR, with p=0.29. There were no moderate or severe side effects on both drugs. CONCLUSION: Clinical outcomes were similar for the two treatments and both treatments were well tolerated. Once daily ciprofloxacin XR was safe, effective, and non-inferior to twice-daily ciprofloxacin IR in the treatment of typhoid fever.