Clinical trial NCT01841203: Dual Point-of-care Test for the Diagnosis of Yaws
Official title: Evaluation of a Rapid Dual Point-of-care Assay for Targeting Antibiotic Treatment for Yaws Eradication: a Prospective Descriptive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Yaws
Keywords: Diagnosis
Rapid tests
non-treponemal serology
eradication
Lead sponsor: Lihir Medical Centre
Sponsor class: OTHER
Collaborators: name: Papua New Guinea Institute of Medical Research
name: Papua New Guinea National Department of Health, Disease Control
name: Divine Word University
name: Barcelona Centre for International Health Research
First posted: 2013-04-26
Enrollment: 703
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from Lihir Island villages in April 2013. This community has been described previously. We will conduct community-based surveys and we invited children aged 1 - 15 years suspected to have yaws by clinical examination to participate in the study. All children for whom a parent or guardian gives written informed consent will be included consecutively

Brief summary: A dual POC immunoassay simultaneously detecting non-treponemal and treponemal antibodies was developed for the diagnosis of infections with T. pallidum. The assay is designed for use in resource-limited settings where challenging conditions (such as lack of electricity, running water, or laboratory equipment) commonly exist. We sought to compare performance of the dual-POC assay for diagnosis of yaws infection with that of the RPR and TPHA as reference standards.

Detailed description: Yaws is an infectious disease caused by Treponema pallidum subspecies pertenue, a bacterium which closely resembles the causative agent of syphilis, and is spread by skin to skin contact. In the field, yaws is diagnosed on the basis of epidemiological context, evocative symptoms and signs and positive serological tests or dark field microscopy. The darkfield microscopy is not easy to perform , hence the interest in serological tests. The serological tests used to confirm yaws are the same as those used to diagnose syphilis. Yaws serologic diagnosis relies on testing for non-treponemal and treponemal antibodies. These antibodies differ markedly with respect to antigenic reactivities and kinetics during the disease process.

Historically screening for yaws has involved the use of nontreponemal tests, such as rapid plasma reagin or venereal disease research laboratory. Positive results of nontreponemal tests of specimens are then confirmed using a more specific treponemal test, such as Treponema pallidum haemagglutination. However, the equipment and personnel requirements for conducting and interpreting these laboratory-tests are rarely available in low-resource settings in developing countries where yaws occurs.

Rapid treponemal tests which detect antibodies to T. pallidum antigen have become popular for the diagnosis of venereal syphilis due to their many advantages. These tests that can be performed outside a laboratory setting with minimal training and using blood collected by a finger prick, which makes them extremely useful in remote areas where laboratories are not available. However, the rapid treponemal tests for syphilis detect treponemal antibodies, which limits their use for interpretation of the disease status since they cannot distinguish between active and past or treated infection.

A combined point-of-care (POC) test which detects both treponemal and non-treponemal antibodies has recently been evaluated for the diagnosis of syphilis, and appears promising for yaws diagnosis. The use of the dual POC test would result in the ability to both screen and confirm the serological status of patients with suspected yaws within 15 minutes and give a better indication of active disease.

Eligibility 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

Primary outcomes:
measure: To determine the accuracy of the dual-test as compared to recognized standard methods
timeFrame: 1 month
Secondary outcomes:
measure: Accuracy of DPP in whole blood and plasma
timeFrame: 1 month
measure: Accuracy of DPP determined by Naked eye and Reader
timeFrame: 1 month
Other outcomes:
Locations:
city: Marup village
country: Papua New Guinea
facility: Karkar Island
state: Madang
city: Londolovit
country: Papua New Guinea
facility: Lihir Medical Centre
state: New Ireland Province
Study officials:
References:
citation: Ayove T, Houniei W, Wangnapi R, Bieb SV, Kazadi W, Luke LN, Manineng C, Moses P, Paru R, Esfandiari J, Alonso PL, de Lazzari E, Bassat Q, Mabey D, Mitja O. Sensitivity and specificity of a rapid point-of-care test for active yaws: a comparative study. Lancet Glob Health. 2014 Jul;2(7):e415-21. doi: 10.1016/S2214-109X(14)70231-1. Epub 2014 May 31.