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Treatment of acute bacterial diarrhea: a multicenter international trial comparing placebo with fleroxacin given as a single dose or once daily for 3 days.
Am J Med. 1993 Mar 22; 94(3A):187S-194S.AJ

Abstract

This study was designed to test the efficacy of 400 mg fleroxacin given orally as a single dose or once daily for 3 days against acute bacterial diarrhea. A group of 508 adults with acute diarrhea were entered into a randomized, double-blind, placebo-controlled, multicenter trial. Patients were examined and asked about numbers of liquid stools daily for 3 days and at 5 days after start of treatment. Repeat stool samples were obtained for culture on days 3 and 5 after start of treatment. A total of 332 patients showed stool cultures positive for bacterial pathogens sensitive to fleroxacin and completed their treatments. Patients treated with fleroxacin, both single-dose and 3-day regimens, showed faster clinical improvement than did placebo-treated patients, as shown by earlier cessation of diarrhea (p < 0.001) and reduction in mean number of loose stools per day on days 2, 3, and 5 after start of therapy (p < 0.05). Bacteriologic efficacy was demonstrated by negative stool cultures for initial pathogens on days 3 and 5 after start of therapy in 94% of patients treated with single doses of fleroxacin and in 93% of patients treated with three doses of fleroxacin as compared with 57% of patients treated with placebo (p < 0.001). Patients with cholera, shigellosis, and infections due to Vibrio parahaemolyticus showed both clinical and bacteriologic responses to fleroxacin treatment, whereas patients with salmonellosis showed only bacteriologic responses. The good overall clinical and bacteriologic responses of most patients with acute bacterial diarrhea of fleroxacin indicate that this convenient single-dose therapy should be advantageous for empiric treatment of certain diarrheal illnesses.

Authors+Show Affiliations

Bamrasnardura Hospital, Nonthaburi, Thailand.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

8452179

Citation

Butler, T, et al. "Treatment of Acute Bacterial Diarrhea: a Multicenter International Trial Comparing Placebo With Fleroxacin Given as a Single Dose or once Daily for 3 Days." The American Journal of Medicine, vol. 94, no. 3A, 1993, 187S-194S.
Butler T, Lolekha S, Rasidi C, et al. Treatment of acute bacterial diarrhea: a multicenter international trial comparing placebo with fleroxacin given as a single dose or once daily for 3 days. Am J Med. 1993;94(3A):187S-194S.
Butler, T., Lolekha, S., Rasidi, C., Kadio, A., del Rosal, P. L., Iskandar, H., Rubinstein, E., & Pastore, G. (1993). Treatment of acute bacterial diarrhea: a multicenter international trial comparing placebo with fleroxacin given as a single dose or once daily for 3 days. The American Journal of Medicine, 94(3A), 187S-194S.
Butler T, et al. Treatment of Acute Bacterial Diarrhea: a Multicenter International Trial Comparing Placebo With Fleroxacin Given as a Single Dose or once Daily for 3 Days. Am J Med. 1993 Mar 22;94(3A):187S-194S. PubMed PMID: 8452179.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment of acute bacterial diarrhea: a multicenter international trial comparing placebo with fleroxacin given as a single dose or once daily for 3 days. AU - Butler,T, AU - Lolekha,S, AU - Rasidi,C, AU - Kadio,A, AU - del Rosal,P L, AU - Iskandar,H, AU - Rubinstein,E, AU - Pastore,G, PY - 1993/3/22/pubmed PY - 1993/3/22/medline PY - 1993/3/22/entrez SP - 187S EP - 194S JF - The American journal of medicine JO - Am J Med VL - 94 IS - 3A N2 - This study was designed to test the efficacy of 400 mg fleroxacin given orally as a single dose or once daily for 3 days against acute bacterial diarrhea. A group of 508 adults with acute diarrhea were entered into a randomized, double-blind, placebo-controlled, multicenter trial. Patients were examined and asked about numbers of liquid stools daily for 3 days and at 5 days after start of treatment. Repeat stool samples were obtained for culture on days 3 and 5 after start of treatment. A total of 332 patients showed stool cultures positive for bacterial pathogens sensitive to fleroxacin and completed their treatments. Patients treated with fleroxacin, both single-dose and 3-day regimens, showed faster clinical improvement than did placebo-treated patients, as shown by earlier cessation of diarrhea (p < 0.001) and reduction in mean number of loose stools per day on days 2, 3, and 5 after start of therapy (p < 0.05). Bacteriologic efficacy was demonstrated by negative stool cultures for initial pathogens on days 3 and 5 after start of therapy in 94% of patients treated with single doses of fleroxacin and in 93% of patients treated with three doses of fleroxacin as compared with 57% of patients treated with placebo (p < 0.001). Patients with cholera, shigellosis, and infections due to Vibrio parahaemolyticus showed both clinical and bacteriologic responses to fleroxacin treatment, whereas patients with salmonellosis showed only bacteriologic responses. The good overall clinical and bacteriologic responses of most patients with acute bacterial diarrhea of fleroxacin indicate that this convenient single-dose therapy should be advantageous for empiric treatment of certain diarrheal illnesses. SN - 0002-9343 UR - https://www.unboundmedicine.com/medline/citation/8452179/Treatment_of_acute_bacterial_diarrhea:_a_multicenter_international_trial_comparing_placebo_with_fleroxacin_given_as_a_single_dose_or_once_daily_for_3_days_ L2 - http://www.diseaseinfosearch.org/result/2258 DB - PRIME DP - Unbound Medicine ER -