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| |  Investigational Prulifloxacin Defeats Traveller's Diarrhoea Faster Than Placebo: Presented at ICAAC/IDSA By Ed Susman WASHINGTON, DC -- October 30, 2008 -- Traveller's diarrhoea, usually caused by bacterial infections, can be cured within 24 hours with doses of the investigational fluoroquinolone antibiotic prulifloxacin, researchers stated here at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and Infectious Diseases Society of America (IDSA) 46th Annual Meeting. American students travelling abroad in Peru and in Mexico were treated at hospital clinics where the placebo-controlled trial was conducted, explained Herbert DuPont, MD, Center for Infectious Diseases and University of Texas-Houston School of Public Health, Houston, Texas. Doctors recruited 187 patients who were randomised to receive 3 daily 600-mg doses of prulifloxacin and 95 other patients who were assigned to placebo. Among the patients on active treatment, the average time to resolution of symptoms was 24.2 hours if the patients took all 3 doses and had an identified known bacterial pathogen; symptoms resolved in about 20.6 hours among those students who took at least 1 dose of medicine in the intent-to-treat group. For placebo patients it was a different story, said Dr. DuPont. "About 52% of the placebo group failed to return to wellness within 120 hours," he said at his poster presentation October 28. "The median time of the last unformed stool -- the primary endpoint of the study -- could not be calculated for the placebo group because the majority of those subjects were declared clinical failures," Dr. DuPont noted. The outcome difference between the groups was significant (P < .0001). Patients taking prulifloxacin returned to wellness with a median time to last unformed stool of about 2 days. "Prulifloxacin and placebo-treated patients had similar safety profiles," said Dr. DuPont. "Prulifloxacin was generally well-tolerated. It is a safe and effective therapy for traveller's diarrhoea." Dr. DuPont added that the drug could be used prophylactically, but he was unaware of any studies examining that at present. The study was funded by Optimer Pharmaceuticals, Inc. [Presentation title: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Prulifloxacin as Therapy for Traveler's Diarrhea. Abstract L-4134]
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