N/A
N=563
Evaluation of a LAMP Assay for T. Pallidum. Pertenue
Yaws
Bottom Line
View on ClinicalTrials.gov: NCT04753788 ↗Enrolled (actual)
563
Serious AEs
—
Results posted
Mar 2025
Primary outcome: Primary: Sensitivity of LAMP vs qpCR — 63.2 Percent
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PCR (Diagnostic_test); LAMP (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- London School of Hygiene and Tropical Medicine
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of LAMP vs qpCR |
63.2 | — |
| PRIMARY Specificity of LAMP for Yaws |
67.1 | — |
Summary
This is a diagnostic evaluation comparing the performance of real-time PCR performed at a national reference laboratory and a LAMP assay performed at a regional hospital for the diagnosis of yaws
Eligibility Criteria
Inclusion Criteria
- Lesion consistent with yaws
- Positive treponemal and non-treponemal antibodies assessed by the DPP Syphilis Screen and Confirm RDT
Exclusion Criteria
- Unable to give consent
Data sourced from ClinicalTrials.gov (NCT04753788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.