OBJECTIVE: The antibacterial efficacy of fleroxacin was compared with that of ciprofloxacin in 72 adult Nigerian patients with typhoid fever. PATIENTS AND METHODS: On inclusion into the study, patients were randomised to treatment with either fleroxacin 400mg once daily for 7 days or ciprofloxacin 500mg twice daily for 14 days. Clinical evaluations were performed on days 0, 1, 2, 3, 5 and 7 or 14, and 2 weeks after treatment. Bacteriology was performed on days 0, 3, 7 or 14, and 21 or 28. Laboratory tolerability parameters were monitored for all patients as well as incidence of adverse events. RESULTS:Bacteriological response on day 3 was 93.5 and 64.0% for fleroxacin and ciprofloxacin, respectively. At term and follow-up there was bacteriological cure in 97.0% of patients with fleroxacin and 100% with ciprofloxacin. The clinical cure was 100% for both groups at term. The incidence of adverse events was 5.4% with fleroxacin and 2.8% with ciprofloxacin. CONCLUSION: The results demonstrated that while the clinical response rate with both drugs was comparable, fleroxacin exhibited a faster bacteriological clearance rate. We therefore concluded that 7 days' therapy with fleroxacin 400mg once daily was as effective as 14 days' therapy with ciprofloxacin 500mg given twice daily in the management of typhoid fever in Nigerian patients. It was also observed that the quinolones possessed greater potential and benefits as first-line therapy for the management of typhoid fever in this environment. The tolerability profile was good for both treatment regimens.
RCT Entities:
OBJECTIVE: The antibacterial efficacy of fleroxacin was compared with that of ciprofloxacin in 72 adult Nigerian patients with typhoid fever. PATIENTS AND METHODS: On inclusion into the study, patients were randomised to treatment with either fleroxacin 400mg once daily for 7 days or ciprofloxacin 500mg twice daily for 14 days. Clinical evaluations were performed on days 0, 1, 2, 3, 5 and 7 or 14, and 2 weeks after treatment. Bacteriology was performed on days 0, 3, 7 or 14, and 21 or 28. Laboratory tolerability parameters were monitored for all patients as well as incidence of adverse events. RESULTS: Bacteriological response on day 3 was 93.5 and 64.0% for fleroxacin and ciprofloxacin, respectively. At term and follow-up there was bacteriological cure in 97.0% of patients with fleroxacin and 100% with ciprofloxacin. The clinical cure was 100% for both groups at term. The incidence of adverse events was 5.4% with fleroxacin and 2.8% with ciprofloxacin. CONCLUSION: The results demonstrated that while the clinical response rate with both drugs was comparable, fleroxacin exhibited a faster bacteriological clearance rate. We therefore concluded that 7 days' therapy with fleroxacin 400mg once daily was as effective as 14 days' therapy with ciprofloxacin 500mg given twice daily in the management of typhoid fever in Nigerian patients. It was also observed that the quinolones possessed greater potential and benefits as first-line therapy for the management of typhoid fever in this environment. The tolerability profile was good for both treatment regimens.
Authors: J Wain; N T Hoa; N T Chinh; H Vinh; M J Everett; T S Diep; N P Day; T Solomon; N J White; L J Piddock; C M Parry Journal: Clin Infect Dis Date: 1997-12 Impact factor: 9.079