OBJECTIVE: To investigate the clinical and bacteriological efficacy of 5- and 7-day pefloxacin therapy in patients with acute infectious diarrhoea. PATIENTS AND STUDY DESIGN:Eighty-two adult patients with acute infectious diarrhoea were randomly divided into three groups: group 1 (n = 20) received 5 days of treatment with pefloxacin, group 2 (n = 27) was assigned to a 7-day pefloxacin protocol, and group 3 (n = 35) was treated symptomatically. The daily dose of pefloxacin was 400mg orally. Clinical and bacteriological response was analysed on the third, fifth and seventh days of treatment as well as 1 and 4 weeks after the end of treatment. The study was an open-labelled, prospective clinical trial. RESULTS: In the 47 patients (100%) of both pefloxacin groups a clinical improvement was noted on the third day compared with the control group, where this occurred on day 7. Bacteriological eradication was verified on the fifth day in 18 patients (90%) from group 1 and in 25 patients (93%) from group 2; they all had negative stool cultures 1 and 4 weeks after therapy was completed. Only 22 patients (63%) in the control group had negative stool cultures on the seventh day of treatment, but 4 weeks later all of them were negative. CONCLUSION: There was no difference in clinical (p = 0.232) and bacteriological (p = 0.972) efficacy between the 5- and 7-day pefloxacin treatment protocols. However, both protocols differed significantly in clinical improvement (p < 0.001) and bacteriological eradication (p = 0.017) from the control group.
RCT Entities:
OBJECTIVE: To investigate the clinical and bacteriological efficacy of 5- and 7-day pefloxacin therapy in patients with acute infectious diarrhoea. PATIENTS AND STUDY DESIGN: Eighty-two adult patients with acute infectious diarrhoea were randomly divided into three groups: group 1 (n = 20) received 5 days of treatment with pefloxacin, group 2 (n = 27) was assigned to a 7-day pefloxacin protocol, and group 3 (n = 35) was treated symptomatically. The daily dose of pefloxacin was 400mg orally. Clinical and bacteriological response was analysed on the third, fifth and seventh days of treatment as well as 1 and 4 weeks after the end of treatment. The study was an open-labelled, prospective clinical trial. RESULTS: In the 47 patients (100%) of both pefloxacin groups a clinical improvement was noted on the third day compared with the control group, where this occurred on day 7. Bacteriological eradication was verified on the fifth day in 18 patients (90%) from group 1 and in 25 patients (93%) from group 2; they all had negative stool cultures 1 and 4 weeks after therapy was completed. Only 22 patients (63%) in the control group had negative stool cultures on the seventh day of treatment, but 4 weeks later all of them were negative. CONCLUSION: There was no difference in clinical (p = 0.232) and bacteriological (p = 0.972) efficacy between the 5- and 7-day pefloxacin treatment protocols. However, both protocols differed significantly in clinical improvement (p < 0.001) and bacteriological eradication (p = 0.017) from the control group.
Authors: D Killalea; L R Ward; D Roberts; J de Louvois; F Sufi; J M Stuart; P G Wall; M Susman; M Schwieger; P J Sanderson; I S Fisher; P S Mead; O N Gill; C L Bartlett; B Rowe Journal: BMJ Date: 1996-11-02