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Treatment of Shigellosis: III. Comparison of One- or Two-Dose Ciprofloxacin with Standard 5-Day Therapy: A Randomized, Blinded Trial

Michael L. Bennish, MD; Mohammed Abdus Salam, MB, BS; Wasif Ali Khan, MB, BS; and Ali Miraj Khan, MB, BS
[+] Article, Author, and Disclosure Information

Grant Support: By a grant from Bayer, Leverkusen, Germany, and by the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B). The ICDDR,B is funded by countries and agencies that share its concern for the health problems of developing countries. Current donors include the aid agencies of the governments of Australia, Bangladesh, Belgium, Canada, Denmark, France, Japan, The Netherlands, Norway, Sweden, Switzerland, the United Kingdom, and the United States; the United Nations Development Program and UNICEF; and the Ford and Sasakawa Foundations. Dr. Bennish is supported by a grant from the Applied Diarrheal Disease Research Project of the United States Agency for International Development.

Requests for Reprints: Michael Bennish, MD, New England Medical Center, 750 Washington Street, Box 041, Boston, MA 02111.

Current Author Addresses: Dr. Bennish, New England Medical Center, 750 Washington Street, Box 041, Boston, MA 02111.

Drs. Salam, W. Khan, and A. Khan: International Centre for Diarrhoeal Disease Research, Bangladesh, GPO Box 128, Dhaka 1000, Bangladesh.

© 1992 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1992;117(9):727-734. doi:10.7326/0003-4819-117-9-727
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Objective: To determine whether a single dose, or 2 doses, of ciprofloxacin are as effective as 5-day, 10-dose therapy for the treatment of shigellosis in adult men who are moderately to severely ill.

Design: Randomized, double-blind clinical trial.

Setting: A diarrhea treatment center in the capital city of a developing country, Bangladesh.

Patients: A total of 128 adult men with dysentery of less than 96 hours duration. All had Shigella organisms isolated from a culture of stool.

Interventions: Patients were randomly assigned to receive either a single 1-gram dose of ciprofloxacin at admission to the study (single-dose group; n = 40), a 1-gram dose of ciprofloxacin at admission and 24 hours later (2-dose group; n = 43), or 500 mg of ciprofloxacin every 12 hours for 5 days (10 dose group; n = 35). All patients were hospitalized for 6 days.

Measurements: Stools were collected individually; their character and consistency were recorded and cultured daily. A physical examination and recording of symptoms were done daily, and the temperature was measured every 4 hours. Therapy was considered to have failed in patients who did not have improvement in the signs and symptoms of dysentery after 72 hours of therapy or in patients who on study day 5 had more than nine stools, or more than two watery stools, or were febrile.

Results: There were no treatment failures in the 78 patients infected with species of Shigella other than Shigella dysenteriae type 1. Among the 40 patients infected with S. dysenteriae type 1, treatment failed in 4 of the 10 patients who received single-dose therapy, 2 of the 15 patients who received 2-dose therapy, and none of the 15 patients who received 10-dose therapy (P = 0.017, single-dose therapy group compared with 10-dose group; P= 0.15 for the single-dose group compared with the 2-dose group; P > 0.2 for the 2-dose group compared with the 10-dose group).

Conclusions: A single 1-gram dose of ciprofloxacin is effective therapy for patients infected with species of Shigella other than S. dysenteriae type 1. Single-dose therapy is inferior to 10-dose therapy for treating patients infected with S. dysenteriae type 1.





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