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Fluids & Electrolytes
WEDNESDAY, Jan. 11 (HealthDay News) -- A single oral-dose of azithromycin is non-inferior compared with the standard recommended therapy of benzathine benzylpenicillin for the treatment of yaws, an endemic treponematosis, according to a study published online Jan. 11 in The Lancet.
Oriol Mitjà, M.D., of the Lihir Medical Centre-International SOS in Papua New Guinea, and colleagues conducted an open-label, randomized trial, including 250 children (aged 6 months to 15 years) with a serologically confirmed diagnosis of yaws. Patients were randomized to receive either one 30 mg/kg oral dose of azithromycin (124 patients allocated) or an intramuscular injection of 50,000 units per kg of benzathine benzylpenicillin (126 patients allocated). Treatment efficacy was the primary end point, with cure rate defined serologically as a reduction in rapid plasma reagin titer of at least two dilutions by six months after treatment, and by epithelialization of lesions within two weeks for participants with primary ulcers. Non-inferiority was achieved if the upper limit of the two-sided 95 percent confidence interval (CI) was lower than 10 percent for the difference in rates.
The researchers found that, after six months of follow-up, 96 percent of patients in the azithromycin group were cured (106 of 110 patients), compared with 93 percent (105 of 113) in the benzathine benzylpenicillin group (treatment difference −3.4 percent; 95 percent CI, −9.3 to 2.4). In both treatment groups there was a similar number of drug-related adverse events, all of which were considered mild or moderate.
"A single oral dose of azithromycin is non-inferior to benzathine benzylpenicillin and avoids the need for injection equipment and medically trained personnel. A change to the simpler azithromycin treatment regimen could enable yaws elimination through mass drug administration programs," the authors write.
The study was funded by International SOS and Newcrest Mining; several authors disclosed financial ties to both companies.
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