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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01955252
• Date of registration: 24/09/2013
• Prospective Registration: No
• Primary sponsor: Lihir Medical Centre
• Public title: Effect of WHO-yaws Elimination Strategy in Lihir Island, Papua New Guinea YESA-13
• Scientific title: Effect of WHO-yaws Elimination Strategy in Lihir Island, Papua New Guinea
• Date of first enrolment: March 2013
• Target sample size: 16000
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01955252
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Papua New Guinea

Contacts

• Name: Oriol Mitja, MD, PhD
• Affiliation: Barcelona Institute for Global Health

Key inclusion & exclusion 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).



Age minimum: 2 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Yaws

Intervention(s)

Drug: Azithromycin

Primary Outcome(s)

Prevalence of yaws latent infection [Time Frame: 42 months]

Secondary Outcome(s)

Ulcer aetiology surveys [Time Frame: 42 months]

Macrolide resistance [Time Frame: 42 months]

Prevalence of active yaws disease [Time Frame: 42 months]

Secondary ID(s)

YESA-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Barcelona Institute for Global Health

World Health Organization

National Department of Health of Papua New Guinea

University of Washington