Yaws
Conditions
Brief 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
Sponsors
Pasteur Institute abidjan
Centre Pasteur du Cameroun
Noguchi Memorial Institute for Medical Research
University of Freiburg
MAST Group - Germany
Friedrich-Loeffler-Institut
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
London School of Hygiene and Tropical Medicine
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of LAMP vs qpCR | 15 Months | A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP |
| Specificity of LAMP for Yaws | 15 Months | Sample negative by qPCR for T.pallidum that is also negative by LAMP |
Countries
Cameroon, Côte d’Ivoire, Ghana
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Suspected Yaws Cases Individuals with a lesion clinically suspected to be yaws and with evidence of positive treponemal and non-treponemal serology as assessed by point of care lateral flow tests (DPP Syphilis Screen and Confirm, Chembio)
PCR: qPCR for T.pallidum
LAMP: LAMP assay for T.pallidum | 525 |
| Total | 525 |
Baseline characteristics
| Characteristic | Suspected Yaws Cases |
|---|---|
| Age, Categorical <=18 years | 525 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 525 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Cameroon | 20 participants |
| Region of Enrollment Congo | 4 participants |
| Region of Enrollment Côte D'Ivoire | 93 participants |
| Region of Enrollment Ghana | 408 participants |
| Sex: Female, Male Female | 149 Participants |
| Sex: Female, Male Male | 376 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Sensitivity of LAMP vs qpCR
A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP
Time frame: 15 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Serologically Confirmed Yaws | Sensitivity of LAMP vs qpCR | 63.2 Percent |
Primary
Specificity of LAMP for Yaws
Sample negative by qPCR for T.pallidum that is also negative by LAMP
Time frame: 15 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Serologically Confirmed Yaws | Specificity of LAMP for Yaws | 67.1 Percent |