Dual Point-of-care Test for the Diagnosis of Yaws

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01841203
• Date of registration: 19/04/2013
• Prospective Registration: No
• Primary sponsor: Oriol Mitja
• Public title: Dual Point-of-care Test for the Diagnosis of Yaws YARADI
• Scientific title: Evaluation of a Rapid Dual Point-of-care Assay for Targeting Antibiotic Treatment for Yaws Eradication: a Prospective Descriptive Study
• Date of first enrolment: April 2013
• Target sample size: 703
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01841203
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Papua New Guinea

Key inclusion & exclusion criteria

Inclusion Criteria:

- Children from 2 to 15 years with clinical suspicion of active yaws

Exclusion Criteria:

- Persons who are unable to sustain venipuncture; persons who do not provide an
informed consent, or withdraw consent



Age minimum: 2 Years
Age maximum: 15 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Yaws

Primary Outcome(s)

To determine the accuracy of the dual-test as compared to recognized standard methods [Time Frame: 1 month]

Secondary Outcome(s)

Accuracy of DPP in whole blood and plasma [Time Frame: 1 month]

Accuracy of DPP determined by Naked eye and Reader [Time Frame: 1 month]

Secondary ID(s)

YARADI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Papua New Guinea Institute of Medical Research

Papua New Guinea National Department of Health, Disease Control

Divine Word University

Barcelona Centre for International Health Research