Cutaneous Leishmaniasis (Diagnosis) Clinical Trial
— RPA-LFOfficial title:
Diagnostic Performance of a Recombinant Polymerase Amplification Test - Lateral Flow (RPA-LF) for Cutaneous Leishmaniasis in an Endemic Setting of Colombia
| Verified date | August 2020 |
| Source | Centro Internacional de Entrenamiento e Investigaciones Médicas |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
CL is public health in the Americas, diagnostic confirmation is required to start treatment,
however current diagnostic methods have several limitations and its access is limited.
Technical requirements of conventional molecular diagnostics and costs preclude their routine
use in primary care facilities in rural areas. A recently developed method of Isothermal
Recombinase Polymerase Amplification (RPA) targeting Leishmania kinetoplast DNA, has shown
high accuracy in detecting Leishmania Viannia spp. We evaluated the diagnostic performance of
the RPA-LF test in a laboratory reference center and field scenario with community
participation.
| Status | Completed |
| Enrollment | 128 |
| Est. completion date | December 20, 2019 |
| Est. primary completion date | December 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility |
Inclusion Criteria: - Men or women with 2 years of age and over of any ethnic group - Ulcerated skin lesions compatible with cutaneous leishmaniasis with two or more weeks of duration - Approval of informed consent Exclusion Criteria: - Mucosal leishmaniasis - Clinical presentations of cutaneous leishmaniasis different of ulcerated lesions |
| Country | Name | City | State |
|---|---|---|---|
| Colombia | Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas | Cali | Valle |
| Lead Sponsor | Collaborator |
|---|---|
| Centro Internacional de Entrenamiento e Investigaciones Médicas | University of Texas |
Colombia,
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* Note: There are 16 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Performance of RPA-LF compared with the composite gold standard (smear, culture, histopathology, and q-PCR-18S) in two scenarios: reference laboratory and field. | Sensitivity, specificity, predictive values (positive and negative) and likelihood ratios with their corresponding 95% confidence intervals will be calculated in both scenarios. We define as true positive (TP) when at least one of the gold standard tests (smear, culture, histopathology or q-PCR-18S) and RPA-LF are positive. A patient was considered true negative (TN) when at least smear, q-PCR-18S were negative and, culture and RPA-LF also resulted in negative. Reference lab scenario refers to when the samples are obtained by highly trained technicians (auxiliary nurses) in urban areas localized in Tumaco in a Primary Health facility and send to the reference center in Cali to be processed. In Reference center samples are taken and processed by an expert microbiologist. Field refers when the samples are obtained by trained community health workers (CHW) and processed by a non-expert field technician in Tumaco in a primary health facility. |
Feb 2018 - August 2020 | |
| Secondary | Performace of RPA-LF compared with 4 aditional reference standards in both scenarios. | Sensitivity, specificity , predictive values (positive and negative) and likelihood ratios and 95% confidence intervals will be also estimated using 4 reference tests 1)the same as the gold standard but without qPCR; 2) lesion smear microscopy and culture; 3) lesion smear microscopy read in reference lab and 4) lesion smear microscopy read in the primary health facility in both scenarios. | Feb 2018 - August 2020 |