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Azithromycin/Loperamide Comparable With Levofloxacin/Loperamide for Treatment of Traveler's Diarrhea: Presented at IDSA

By Rabiya Tuma

SAN FRANCISCO, CA -- October 11, 2005 -- Azithromycin and loperamide works as well as, but is slower to take effect than levofloxacin and loperamide for the treatment of traveler's diarrhea, according to results of a randomized controlled trial.

Previous trials compared levofloxacin with azithromycin, but the antibiotics have not been compared previously when paired with loperamide. John W. Sanders, MD, on the US Incirlik Air Base in Turkey and colleagues compared the efficacy of loperamide in combination with either azithromycin or levofloxacin.

Between June 2003 and August 2004, 222 military personnel with noninflammatory diarrhea were randomly assigned to receive either a single 1000-mg dose of azithromycin or a single 500-mg dose of levofloxacin. Both groups were given 4-mg loperamide initially, which was repeated as needed.

Of the 105 patients evaluable in the azithromycin arm, the median time between therapy and passing of last diarrheal stool was 13 hours compared with a median time of 3 hours for the 100 evaluable patients treated with levofloxacin. Approximately one third of patients in each study arm required an additional dose of loperamide.

"More than a quarter of individuals had rapid resolution of diarrhea as measured by no more additional diarrheal stools after regimen dosing," Dr. Sanders said at the 43^rd Annual Meeting of the Infectious Diseases Society of America (IDSA).

There was no overall significant difference in the rate of microbiological cure between the 2 arms, with approximately one quarter in each arm achieving a cure.

The most common cause of the diarrhea was enterotoxigenic Escherichia coli accounting for just over 40% in each arm. Campylobacter was the second most common agent, accounting for 6% of cases in the azithromycin arm and 9% in the levofloxacin arm.

Although the 2 combinations worked equally well on E. coli, levofloxacin did not result in any microbiological cures in Campylobacter infected patients.

Azithromycin was associated with significantly more postdosing nausea than levofloxacin, (8% vs 1%), but was not considered to be a major problem, Dr. Sanders reported.

Because of resistance problems, Dr. Sanders concluded that "azithromycin-based regimens appear to be the best for world-wide use."

"Although we were looking at military personnel, these are the exact same bugs that tourists and business travelers get," Dr. Sanders said. "The data is definitely translatable to a civilian population."


[Presentation title: Azithromycin and Loperamide is Comparable to Levofloxacin and Loperamide for the Treatment of Traveler's Diarrhea in U.S. Military Personnel in Turkey. Abstract 301]

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