Effect of WHO-yaws Elimination Strategy in Lihir Island, Papua New Guinea
Information source: Lihir Medical Centre
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Yaws
Intervention: Azithromycin (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Lihir Medical Centre Official(s) and/or principal investigator(s): Oriol Mitja, MD, PhD, Principal Investigator, Affiliation: Barcelona Institute for Global Health
Summary
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.
Clinical Details
Official title: Effect of WHO-yaws Elimination Strategy in Lihir Island, Papua New Guinea
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Prevalence of yaws latent infection
Secondary outcome: Prevalence of active yaws diseaseMacrolide resistance Ulcer aetiology surveys
Detailed description:
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.
Eligibility
Minimum age: 2 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Whole resident population for MDA and clinical surveys, and children 5-15 years in
sentinel sites for cross-sectional serological surveys.
Exclusion Criteria:
- Children younger than 2 months and pregnant women;
- Known allergy to macrolide antibiotics;
- Refusal of individual or guardian (for individual inclusion).
Locations and Contacts
Lihir Medical Centre, Londolovit, New ireland province 034, Papua New Guinea
Additional Information
Starting date: March 2013
Last updated: March 31, 2015
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