Repurposing Clinically Approved Drugs for Yaws With an Insight Into the Cutaneous Ulcer Disease Syndrome (Trep-AByaws)
NCT05764876
Bacterial Infections, Bacterial Infections and Mycoses
Port Moresby, Papua New Guinea
View Trial DetailsNCT Number: NCT01841203
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.
Looking for future studies?
Notify Me2 year–15 year
All sexes
Observational
Karkar Island, Marup Village, Madang Province, Papua New Guinea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 month
Sensitivity and Specificity as compared to RPR and TPHA
Time frame: 1 month
Specimens will be randomly tested using DPP, either in plasma or blood.
Sensitivity and Specificity of DPP in whole blood and DPP in plasma will be compared.
Time frame: 1 month
Specimens will be tested using DPP, read by naked eye and also using automated reader.
Sensitivity and Specificity of DPP result read by naked eye and DPP using automated reader will be compared.
Oriol Mitja
Other
Evaluation of a Rapid Dual Point-of-care Assay for Targeting Antibiotic Treatment for Yaws Eradication: a Prospective Descriptive Study
Acronym: YARADI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05764876
Bacterial Infections, Bacterial Infections and Mycoses
Port Moresby, Papua New Guinea
View Trial DetailsNCT04753788
Bacterial Infections, Bacterial Infections and Mycoses
Yaoundé, Cameroon
View Trial DetailsNCT03683745
Actinomycetales Infections, Bacterial Infections
Harper, Maryland County, Liberia
View Trial DetailsNCT03490123
Bacterial Infections, Bacterial Infections and Mycoses
Kavieng, New Ireland Province, Papua New Guinea
View Trial Details