BACKGROUND: Single-dose azithromycin is effective in the treatment of severe cholera in children, but its effectiveness in adults has not been evaluated. METHODS: We conducted a double-blind, randomized trial comparin...BACKGROUND: Single-dose azithromycin is effective in the treatment of severe cholera in children, but its effectiveness in adults has not been evaluated. METHODS: We conducted a double-blind, randomized trial comparing the equivalence of azithromycin and ciprof loxacin (each given in a single 1-g dose of two 500-mg tablets) among 195 men with severe cholera caused by Vibrio cholerae O1 or O139. Patients were hospitalized for five days. A stool culture was performed daily. Primary outcome measures were clinical success (the cessation of watery stools within 48 hours after drug administration) and bacteriologic success (the inability to isolate V. cholerae after 48 hours). RESULTS: Therapy was clinically successful in 71 of 97 patients receiving azithromycin (73 percent) and in 26 of 98 patients receiving ciprofloxacin (27 percent) (P < 0.001) and bacteriologically successful in 76 of 97 patients receiving azithromycin (78 percent) and in 10 of 98 patients receiving ciprofloxacin (10 percent) (P< 0.001). Patients who were treated with azithromycin had a shorter duration of diarrhea than did patients treated with ciprofloxacin (median, 30 vs. 78 hours); a lower frequency of vomiting (43 percent vs. 67 percent); fewer stools (median, 36 vs. 52); and a lower stool volume (median, 114 vs. 322 ml per kilogram of body weight). The median minimal inhibitory concentration of ciprofloxacin for the 177 isolates of V. cholerae O1 was 0.25 μg per milliliter, which was 11 to 83 times as high as that in previous studies at this site. CONCLUSIONS: Single-dose azithromycin was effective in the treatment of severe cholera in adults. The lack of efficacy of ciprofloxacin may result from its diminished activity against V. cholerae O1 strains currently circulating in Bangladesh.展开更多
Background: Single- dose ciprofloxacin is effective for the treatment of severe cholera in adults. We assessed whether single- dose ciprofloxacin would be as effective as 3- day, 12- dose erythromycin in achieving cli...Background: Single- dose ciprofloxacin is effective for the treatment of severe cholera in adults. We assessed whether single- dose ciprofloxacin would be as effective as 3- day, 12- dose erythromycin in achieving clinical cure in children with severe cholera. Methods: We did a randomised, open label, controlled trial in children age 2- 15 years with V cholerae O1 or O139 present in stool on dark- field microscopy. Children received either a single 20 mg/kg dose of ciprofloxacin (n = 90) or 12.5 mg/kg of erythromycin (n = 90) every 6 h for 3 days, and remained in hospital for 5 days. The primary outcome was clinical success of treatment, defined as cessation of watery stools within 48 h of start of drug treatment. Analysis was per protocol. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN00142272. Findings: Of 10 children randomised 162 completed the study. Treatment was clinically successful in 60% (47/78) of children treated with ciprofloxacin and in 55% (46/84) of those treated with erythromycin (difference 5% 95% CI - 10 to 21). Children receiving ciprofloxacin vomited less often (58% vs 74% ; difference 16% 2 to 30), had fewer stools (15 vs 21; 6 0 to 9), and less stool volume (152 vs 196 mL/kg; 43 mL/kg 13 to 87) than those receiving erythromycin. Bacteriological failure was more common in ciprofloxacin- treated patients (58% vs 30% ; 28% 13 to 43) than erythromycin- treated patients. Interpretation: Single- dose ciprofloxacin achieves clinical outcomes similar to, or better than, those achieved with 12- dose erythromycin treatment in childhood cholera, but is less effective in eradicating V cholerae from stool.展开更多
文摘BACKGROUND: Single-dose azithromycin is effective in the treatment of severe cholera in children, but its effectiveness in adults has not been evaluated. METHODS: We conducted a double-blind, randomized trial comparing the equivalence of azithromycin and ciprof loxacin (each given in a single 1-g dose of two 500-mg tablets) among 195 men with severe cholera caused by Vibrio cholerae O1 or O139. Patients were hospitalized for five days. A stool culture was performed daily. Primary outcome measures were clinical success (the cessation of watery stools within 48 hours after drug administration) and bacteriologic success (the inability to isolate V. cholerae after 48 hours). RESULTS: Therapy was clinically successful in 71 of 97 patients receiving azithromycin (73 percent) and in 26 of 98 patients receiving ciprofloxacin (27 percent) (P < 0.001) and bacteriologically successful in 76 of 97 patients receiving azithromycin (78 percent) and in 10 of 98 patients receiving ciprofloxacin (10 percent) (P< 0.001). Patients who were treated with azithromycin had a shorter duration of diarrhea than did patients treated with ciprofloxacin (median, 30 vs. 78 hours); a lower frequency of vomiting (43 percent vs. 67 percent); fewer stools (median, 36 vs. 52); and a lower stool volume (median, 114 vs. 322 ml per kilogram of body weight). The median minimal inhibitory concentration of ciprofloxacin for the 177 isolates of V. cholerae O1 was 0.25 μg per milliliter, which was 11 to 83 times as high as that in previous studies at this site. CONCLUSIONS: Single-dose azithromycin was effective in the treatment of severe cholera in adults. The lack of efficacy of ciprofloxacin may result from its diminished activity against V. cholerae O1 strains currently circulating in Bangladesh.
文摘Background: Single- dose ciprofloxacin is effective for the treatment of severe cholera in adults. We assessed whether single- dose ciprofloxacin would be as effective as 3- day, 12- dose erythromycin in achieving clinical cure in children with severe cholera. Methods: We did a randomised, open label, controlled trial in children age 2- 15 years with V cholerae O1 or O139 present in stool on dark- field microscopy. Children received either a single 20 mg/kg dose of ciprofloxacin (n = 90) or 12.5 mg/kg of erythromycin (n = 90) every 6 h for 3 days, and remained in hospital for 5 days. The primary outcome was clinical success of treatment, defined as cessation of watery stools within 48 h of start of drug treatment. Analysis was per protocol. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN00142272. Findings: Of 10 children randomised 162 completed the study. Treatment was clinically successful in 60% (47/78) of children treated with ciprofloxacin and in 55% (46/84) of those treated with erythromycin (difference 5% 95% CI - 10 to 21). Children receiving ciprofloxacin vomited less often (58% vs 74% ; difference 16% 2 to 30), had fewer stools (15 vs 21; 6 0 to 9), and less stool volume (152 vs 196 mL/kg; 43 mL/kg 13 to 87) than those receiving erythromycin. Bacteriological failure was more common in ciprofloxacin- treated patients (58% vs 30% ; 28% 13 to 43) than erythromycin- treated patients. Interpretation: Single- dose ciprofloxacin achieves clinical outcomes similar to, or better than, those achieved with 12- dose erythromycin treatment in childhood cholera, but is less effective in eradicating V cholerae from stool.
