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| Name | Class |
|---|---|
| Pasteur Institute abidjan | UNKNOWN |
| Centre Pasteur du Cameroun | OTHER |
| Noguchi Memorial Institute for Medical Research | OTHER |
| University of Freiburg |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCR | Diagnostic Test | qPCR for T.pallidum |
| |
| LAMP |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of LAMP vs qpCR | A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP | 15 Months |
| Specificity of LAMP for Yaws | Sample negative by qPCR for T.pallidum that is also negative by LAMP | 15 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with clinically suspected yaws lesions in Ghana, Cote d'Ivoire and Cameroon will be screened using the DPP Syphilis Screen and Confirm RDT. If positive samples will be taken for PCR and LAMP testing.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Pasteur | Yaoundé | Cameroon | ||||
| Institut Pasteur |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35351731 | Derived | Handley BL, Gonzalez-Beiras C, Tchatchouang S, Basing LA, Hugues KA, Bakheit M, Becherer L, Ries C, Njih Tabah E, Crucitti T, Borst N, Luert S, Frischmann S, Haerpfer T, Landmann E, Amanor I, Sylla A, Kouame-Sina MS, Ndzomo-Ngono JP, Tano A, Arhinful D, Awondo P, Ngazoa Kakou S, Eyangoh S, Addo KK, Harding-Esch EM, Knauf S, Mitja O, Marks M. LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification - protocol for a cross-sectional, observational, diagnostic accuracy study. BMJ Open. 2022 Mar 29;12(3):e058605. doi: 10.1136/bmjopen-2021-058605. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity of LAMP vs qpCR | A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP | Posted | Number | 95% Confidence Interval | Percent | 15 Months |
|
|
This is a diagnostic accuracy study without collection of data on AE/SAEs
This is a diagnostic accuracy study without collection of data on AE/SAEs
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Michael Marks | LSHTM | +44020 7636 8636 | michael.marks@lshtm.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2020 | Apr 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015001 | Yaws |
| ID | Term |
|---|---|
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
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| OTHER |
| MAST Group - Germany | UNKNOWN |
| Friedrich-Loeffler-Institut | UNKNOWN |
| Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | OTHER |
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| Diagnostic Test |
LAMP assay for T.pallidum |
|
| Abidjan |
| Côte d’Ivoire |
| Noguchi Memorial Institute of Medical Research | Accra | Ghana |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Specificity of LAMP for Yaws | Sample negative by qPCR for T.pallidum that is also negative by LAMP | Posted | Number | 95% Confidence Interval | Percent | 15 Months |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |