Single-dose Azithromycin for the Treatment of Yaws
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
Yaws, an endemic treponematosis and as such a neglected tropical disease (NTD), is currently
making a comeback in children in rural areas. Injectable long acting penicillin remains the
drug of choice for the treatment of yaws. However, on the basis of successful experience with
venereal syphilis in large-scale studies, oral azithromycin has emerged as a potential
alternative that overcomes the major medical and logistic disadvantages of the current
regimen.
In this non-inferiority randomized clinical trial the investigators propose a comparable
scheme for the treatment of yaws, to test the efficacy of a single, oral dose of azithromycin
versus a single, i.m. dose of benzathine penicillin G.Sample size has been calculated to
detect a non-inferiority margin of 10%. Children < 15 years of age with a confirmed diagnosis
of yaws will be randomly assigned to receive 30mg/Kg (maximum 2g) of azithromycin orally or
50.000units/Kg (maximum 2.4MU) of penicillin-G-benzathine intramuscularly. The primary
outcome is treatment efficacy, with cure defined serologically (a decline in the VDRL titer
of at least two dilutions by six months after treatment) and, in primary yaws, also by
epithelialization of ulcers within two weeks.
Phase:
Phase 3
Details
Lead Sponsor:
Lihir Medical Centre
Collaborator:
Centre For International Health
Treatments:
Azithromycin Penicillin G Penicillin G Benzathine Penicillin G Procaine Penicillins