NORFLOXACIN FOR . THE PROPHYLAXIS OF TRAVELtRS ' DIARRHEA IN U . S . MILITARY PERSONNEL

Abstract

Norfloxacin. an oral fluoroquinolone (dose 400 mg daily). was compared to a placebo in a double blinded randomized tral for the prophylaxis of travelers' diarrhea. The study was of U.S. Navy and Marine Corps personnel on shore leave in Alexandria, Egypt. A total of 222 subjects were available (105 norfloxacin. 117 placebo). In the placebo group, 26% (30/117) developed acute diarrhea vs. 2% (2/105) in the norfloxacin group. There were no significant side effects in either group. Acute diarrhea is a concern for travelers tandrna. Egypt. alter completing a I week port call developing countries. Although a diarrheal illto Naples. Italy. volunteers were recruited from ness rarely produces mortality in healthy poputhe crew of >5,000. Since departing the United lations. it can ir.,pair an individual's ability to States, the earner had visited no other ports befunction. Attack ;-ates vary, but reports of up to fore traveling to Naples and Alexandria. 40% are not unct-mmon.' Numerous strategies A brief history was taken from potential stud,. involving dietary discretion, bismuth subsalisubjects to determine eligibility. Volunteers were cylate prophylaxis and 'ntihiotic prophylaxis disqualified if they gave a history of sensitivit" have been tried to prevent acute diarrhea.' ' to quinolone antibiotics. renal disease ofany type. Norfloxacin, the first fluoroquinolone to be apor diarrhea in the prior month. Informed consent proved in the United States, has excellent in vitro was obtained from each volunteer, and a preactivity against most known bacterial enteric treatment stool specimen was collected. Subjects pathogens. including Campylobacter. Vibros, and were blindly randomized to receivt either norYersmnha.6 It is well tolerated, and resistance apfloxacin (400 mg once a day) or an identical apparently does not develop as rapidly as with nalpearing placebo. idixic acid.' Bacterial enteropathogens resistant Study subjects were instructed to take I capto other antibiotics are common in Egypt, and sule daily beginning the day prior to arrival in may decrease the effectiveness of prophylactic Alexandria and to continue until the morning of antibiotics.' I The drug was found to be effective the ship's departure (7 days). Participants were at a dose of 200 mg twice daily in Swedish tourinstructed to report to the medical department ists traveling in Africa, Asia. and Latin Ameriimmediately if diarrhea developed. ca.'" Among students traveling to Mexico, it was Diarrhea was defined as 4 unformed stools in 88% effective, and resistant bacteria were not a 24 hr period, or 3 unformed stools plus any of observed." the following: abdominal pain, cramps. fever, Although the general use of prophylactic annausea, or vomiting. Diarrhea developing after tibiotics by travelers has been discouraged, it may arrival in port and within 96 hr of leaving Albe appropriate in selected populations. This study exandria was attributed to the port call. Ifa subwas undertaken to evaluate the efficacy of norject developed diarrhea. study prophylaxis was floxacin in preventing travelers' diarrhea among discontinued and the subject was treated as clinU.S. Navy and Marine Corps personnel visiting ically indicated. Alexandria. Egypt. Each subject was asked to complete a questionnaire designed to assess compliance, potenMATERL41S AND METHODS tial side effects, locations visited, and dietary habits while ashore. Questionnaires were comThe study was conducted during August and pleted either when the subject developed diarSeptemiier 1988 on board the USS John F. Kenrhea or 4-5 days after leaving Alexandria. nedv. During the week prior to amval in AlexPre-treatment stool specimens were stored in 160

Cite this paper

@inproceedings{NORFLOXACINF, title={NORFLOXACIN FOR . THE PROPHYLAXIS OF TRAVELtRS ' DIARRHEA IN U . S . MILITARY PERSONNEL}, author={DANIEL A . and RICHARD L . and Scott and Kenneth Craig Hyams} }