Yaws Clinical Trial
Official title:
Effect of WHO-yaws Elimination Strategy in Lihir Island, Papua New Guinea
The trial that the investigators are proposing is a pilot study to determine the effect of the new WHO-yaws eradication strategy in Lihir Island (population 18,000), Papua New Guinea. New treatment policies were developed by WHO in 2012 to replace those of the 1950s. The recommended practice is to offer an initial MDA with azithromycin to the entire population, followed by resurveys every 6 months to detect and treat remaining cases.We will use serology surveys, clinical surveys and ulcer aetiology studies to measure the effect of mass azithromycin treatment on the community burden of yaws infection.
Yaws is a re-emerging endemic treponemal infection caused by Treponema pallidum subp
pertenue. This bacterium causes a chronic relapsing disease, characterized by highly
contagious primary and secondary cutaneous lesions and non-contagious tertiary late
destructive lesions. The Pacific Islands are believed to be a major focus of yaws worldwide,
though population-based data on prevalence are lacking for many countries.
Azithromycin (30mg/kg) has recently been shown to be effective in the treatment of yaws and
is now central to WHO's yaws eradication strategy. Substituting a single dose of an oral
antibiotic for a painful penicillin injection is a significant advantage because infection
control measures required for injection of penicillin will no longer be required and
treatment will be more acceptable to communities who need it.
Previous attempts to eradicate yaws by mass treatment of active cases with injectable drugs
yielded unsuccessful results. A major campaign to eradicate yaws in the 1950s and 1960s with
longacting, injectable penicillin greatly reduced the number of cases of the disease
worldwide but incubating and latent cases that were not treated developed relapses with
infectious yaws lesions, thereby becoming a source of reinfection.
While the earlier strategy in the 1950s, targeted just those people who were visibly
infected, the new WHO-plan calls for blanket coverage of at least 90% of the population. The
ratio of clinically apparent to latent cases with no symptoms is estimated as high as 1:6 and
mass drug administration (MDA) of the entire population is the best approach to ensure that
incubating and latent infections are adequately dealt with.
The currently recommended treatment for eradication is one dose of oral azithromycin (30
mg/Kg; maximum 2g) to be given to entire populations in areas known to harbor yaws. For the
MDA to be effective, it is required to have substantial coverage in the first round. The
initial mass treatment should be followed by resurveys every 6 months to detect and treat
remaining cases.
Because of the potential bacterial resistance appearance treatment failure needs to be
monitored. Macrolide resistance is associated with point mutations at positions A2058 and
A2059 of the 23S ribosomal RNA gene and molecular analysis need to be done in clinical
specimens from patients who do not respond to treatment.
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