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Effect of WHO-yaws Elimination Strategy in Lihir Island, Papua New Guinea

NCT01955252 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16000

Last updated 2017-08-28

No results posted yet for this study

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.

Conditions

  • Yaws

Interventions

DRUG

Azithromycin

Investigators will do a baseline survey of every children from 5 to 15 years in the village. To detect yaws infection, investigators will collect a blood specimen for serology (qualitative and quantitative RPR testing and TPHA assay). Investigators will identify yaws-like ulcers by means of dermatological examination. Investigators will swab papilloma and ulcers and specimens will be flown to University of Washington (Seattle). PCR methods will consist of primary screening for the presence or absence of T. p. pertenue DNA, Haemophilus ducreyi DNA and detection of the A2058G and A2059G mutations associated with azithromycin resistance. Investigators will begin treatment with antibiotics immediately after completion of the baseline survey. Everyone in the villages will be offered azithromycin, subsequently a field team will treat all active clinical cases and their contacts 6 monthly. For all subjects, follow-up examination will be performed at 6,12,18,24,30,36,40,and 42 months

Sponsors & Collaborators

  • Barcelona Institute for Global Health

    collaborator OTHER

  • National Department of Health of Papua New Guinea

    collaborator UNKNOWN

  • World Health Organization

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Lihir Medical Centre

    lead OTHER

Principal Investigators

  • Oriol Mitja, MD, PhD · Barcelona Institute for Global Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Papua New Guinea

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01955252 on ClinicalTrials.gov