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Previous Volume 354:2452-2462 June 8, 2006 Number 23 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Guerrant, R. L. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

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 ciprofloxacin (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. (ClinicalTrials.gov number, NCT00229944 [ClinicalTrials.gov] .)

Source Information

From the International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh (D.S., M.M.K., W.A.K., S.A., M.A.S.); the School of Family Medicine and Public Health, University of KwaZulu-Natal, Durban, South Africa (M.L.B.); and the Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom (M.L.B.).

Address reprint requests to Dr. Saha at the Clinical Sciences Division, ICDDR, B–Centre for Health and Population Research, G.P.O. Box 128, Dhaka 1000, Bangladesh, or at dsaha{at}icddrb.org.

Full Text of this Article

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