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Norfloxacin, a new quinolone carboxylic acid derivative, was compared with an identical-appearing placebo preparation in a prospective, randomized, double-blind trial for prevention of traveler's diarrhea among 120 U.S. students arriving in Mexico. Prophylaxis was continued for 2 weeks. Diarrhea was defined as four unformed stools in 24 h plus an additional symptom of enteric disease. In the norfloxacin prophylaxis group, 4 of 56 subjects (7%) experienced diarrhea, compared with 36 of 59 subjects (61%) in the placebo group. The difference was significant (P less than 0.0001). In contrast to our previous experience with use of trimethoprim-sulfamethoxazole to prevent traveler's diarrhea, quantitative stool cultures in the norfloxacin-treated group revealed a significant decline of normal aerobic fecal flora during prophylaxis (P less than 0.0005). Among stool samples from norfloxacin-treated subjects, 32 of 38 (84%) cultured on day 7 and 34 of 37 (92%) cultured on day 14 had no gram-negative bacilli. After norfloxacin was discontinued, fecal flora returned to pretreatment levels. No gram-negative aerobic flora resistant to norfloxacin were found during weekly quantitative cultures before, during, or after therapy.

Lack of emergence of resistant fecal flora during successful prophylaxis of traveler's diarrhea with norfloxacin