Abstract | BACKGROUND: METHODS: We did an open-label, non-inferiority, randomised trial at Lihir Medical Centre, Papua New Guinea, between Sept 1, 2010, and Feb 1, 2011. Children aged 6 months to 15 years with a serologically confirmed diagnosis of yaws were randomly allocated, by a computer-generated randomisation sequence, to receive either one 30 mg/kg oral dose of azithromycin or an intramuscular injection of 50,000 units per kg benzathine benzylpenicillin. Investigators were masked to group assignment. The primary endpoint was treatment efficacy, with cure rate defined serologically as a decrease in rapid plasma reagin titre of at least two dilutions by 6 months after treatment, and, in participants with primary ulcers, also by epithelialisation of lesions within 2 weeks. Non-inferiority was shown if the upper limit of the two-sided 95% CI for the difference in rates was lower than 10%. The primary analysis was per protocol. This trial is registered with ClinicalTrials.gov, number NCT01382004. FINDINGS: INTERPRETATION: FUNDING: International SOS and Newcrest Mining.
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Authors | Oriol Mitjà, Russell Hays, Anthony Ipai, Moses Penias, Raymond Paru, David Fagaho, Elisa de Lazzari, Quique Bassat |
Journal | Lancet (London, England)
(Lancet)
Vol. 379
Issue 9813
Pg. 342-7
(Jan 28 2012)
ISSN: 1474-547X [Electronic] England |
PMID | 22240407
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2012 Elsevier Ltd. All rights reserved. |
Chemical References |
- Anti-Bacterial Agents
- Azithromycin
- Penicillin G Benzathine
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Topics |
- Administration, Oral
- Adolescent
- Anti-Bacterial Agents
(administration & dosage)
- Azithromycin
(administration & dosage)
- Child
- Child, Preschool
- Female
- Humans
- Infant
- Injections, Intramuscular
- Male
- Papua New Guinea
- Penicillin G Benzathine
(administration & dosage)
- Yaws
(drug therapy)
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