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Cutaneous Leishmaniasis (Diagnosis)RPA-LFNCT04500873

Performance of RPA-LF for Cutaneous Leishmaniasis

An observational study of Cutaneous Leishmaniasis (Diagnosis), run by Centro Internacional de Entrenamiento e Investigaciones Médicas at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Cutaneous Leishmaniasis (Diagnosis)
How many people
128 participants
Where
1 siteColombia
Study dates
1 Feb 2018to 20 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants with cutaneous lesions compatible with cutaneous leishmaniasis from South west of Colombia

Who may be able to join

  • 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

Who cannot join

  • Mucosal leishmaniasis
  • Clinical presentations of cutaneous leishmaniasis different of ulcerated lesions

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas

    Cali, Valle del Cauca Department, 5930

Other trials in Colombia

About this study

Official title: Diagnostic Performance of a Recombinant Polymerase Amplification Test - Lateral Flow (RPA-LF) for Cutaneous Leishmaniasis in an Endemic Setting of Colombia

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.

Read the detailed description

CL is public health in the Americas with an average of 55,000 cases per year between 2001 - 2018 in 17 countries, which mainly occur in rural areas with an average of 55,000 cases per year between 2001 - 2018 in 17 countries. Diagnostic confirmation is required to start treatment, however current diagnostic methods have several limitations, and sometimes it is necessary to perform confirmatory tests that are not available in endemic areas.

Several molecular diagnostic tests have been developed for the diagnosis of CL, however, the technical requirements and costs of sample processing by conventional or quantitative PCR preclude their routine use in primary care facilities in resource-constrained settings. A recently developed method of Isothermal Recombinase Polymerase Amplification (RPA) targeting Leishmania kinetoplast DNA, coupled with lateral flow (LF) immunochromatographic strip has shown high accuracy in detecting Leishmania Viannia spp. We evaluated the diagnostic performance of RPA-LF test in two scenarios: laboratory reference center and field with community participation.

Medical subject headings
Leishmaniasis, Cutaneous, Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Feb 2018 - August 2020

Secondary outcomes (1)

  1. 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.

    Measured: Feb 2018 - August 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2020
  2. Study start1 Feb 2018
  3. Primary completion20 Dec 2019
  4. Study completion20 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04500873
Sponsor's protocol ID
222972553501
Other IDs
222972553501
Acronym
RPA-LF
Status last verified
Aug 2020
First submitted
3 Aug 2020
Last updated
5 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Alvar J, Velez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team. Leishmaniasis worldwide and global estimates of its incidence. PLoS One. 2012;7(5):e35671. doi: 10.1371/journal.pone.0035671. Epub 2012 May 31.

    PubMed 22693548

  • Reveiz L, Maia-Elkhoury AN, Nicholls RS, Romero GA, Yadon ZE. Interventions for American cutaneous and mucocutaneous leishmaniasis: a systematic review update. PLoS One. 2013 Apr 29;8(4):e61843. doi: 10.1371/journal.pone.0061843. Print 2013.

    PubMed 23637917

  • Gomes CM, Paula NA, Morais OO, Soares KA, Roselino AM, Sampaio RN. Complementary exams in the diagnosis of American tegumentary leishmaniasis. An Bras Dermatol. 2014 Sep-Oct;89(5):701-9. doi: 10.1590/abd1806-4841.20142389.

    PubMed 25184908

  • Weigle KA, de Davalos M, Heredia P, Molineros R, Saravia NG, D'Alessandro A. Diagnosis of cutaneous and mucocutaneous leishmaniasis in Colombia: a comparison of seven methods. Am J Trop Med Hyg. 1987 May;36(3):489-96. doi: 10.4269/ajtmh.1987.36.489.

    PubMed 2437815

  • Boggild AK, Ramos AP, Espinosa D, Valencia BM, Veland N, Miranda-Verastegui C, Arevalo J, Low DE, Llanos-Cuentas A. Clinical and demographic stratification of test performance: a pooled analysis of five laboratory diagnostic methods for American cutaneous leishmaniasis. Am J Trop Med Hyg. 2010 Aug;83(2):345-50. doi: 10.4269/ajtmh.2010.09-0414.

    PubMed 20682880

  • Braz LMA. Tegumentary leishmaniasis diagnosis: what happened with MST (Montenegro Skin Test) in Brazil? Rev Inst Med Trop Sao Paulo. 2019 Mar 11;61:e17. doi: 10.1590/S1678-9946201961017. No abstract available.

    PubMed 30864622

  • Aronson N, Herwaldt BL, Libman M, Pearson R, Lopez-Velez R, Weina P, Carvalho EM, Ephros M, Jeronimo S, Magill A. Diagnosis and Treatment of Leishmaniasis: Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH). Clin Infect Dis. 2016 Dec 15;63(12):e202-e264. doi: 10.1093/cid/ciw670. Epub 2016 Nov 14.

    PubMed 27941151

  • de Vries HJ, Reedijk SH, Schallig HD. Cutaneous leishmaniasis: recent developments in diagnosis and management. Am J Clin Dermatol. 2015 Apr;16(2):99-109. doi: 10.1007/s40257-015-0114-z.

    PubMed 25687688

  • Adams ER, Gomez MA, Scheske L, Rios R, Marquez R, Cossio A, Albertini A, Schallig H, Saravia NG. Sensitive diagnosis of cutaneous leishmaniasis by lesion swab sampling coupled to qPCR. Parasitology. 2014 Dec;141(14):1891-7. doi: 10.1017/S0031182014001280. Epub 2014 Aug 11.

    PubMed 25111885

  • Motazedian H, Karamian M, Noyes HA, Ardehali S. DNA extraction and amplification of leishmania from archived, Giemsa-stained slides, for the diagnosis of cutaneous Leishmaniasis by PCR. Ann Trop Med Parasitol. 2002 Jan;96(1):31-4. doi: 10.1179/000349802125000484.

    PubMed 11989531

  • Jara M, Adaui V, Valencia BM, Martinez D, Alba M, Castrillon C, Cruz M, Cruz I, Van der Auwera G, Llanos-Cuentas A, Dujardin JC, Arevalo J. Real-time PCR assay for detection and quantification of Leishmania (Viannia) organisms in skin and mucosal lesions: exploratory study of parasite load and clinical parameters. J Clin Microbiol. 2013 Jun;51(6):1826-33. doi: 10.1128/JCM.00208-13. Epub 2013 Apr 3.

    PubMed 23554201

  • Weigle KA, Labrada LA, Lozano C, Santrich C, Barker DC. PCR-based diagnosis of acute and chronic cutaneous leishmaniasis caused by Leishmania (Viannia). J Clin Microbiol. 2002 Feb;40(2):601-6. doi: 10.1128/JCM.40.2.601-606.2002.

    PubMed 11825977

  • Faber WR, Oskam L, van Gool T, Kroon NC, Knegt-Junk KJ, Hofwegen H, van der Wal AC, Kager PA. Value of diagnostic techniques for cutaneous leishmaniasis. J Am Acad Dermatol. 2003 Jul;49(1):70-4. doi: 10.1067/mjd.2003.492.

    PubMed 12833011

  • Bensoussan E, Nasereddin A, Jonas F, Schnur LF, Jaffe CL. Comparison of PCR assays for diagnosis of cutaneous leishmaniasis. J Clin Microbiol. 2006 Apr;44(4):1435-9. doi: 10.1128/JCM.44.4.1435-1439.2006.

    PubMed 16597873

  • Saldarriaga OA, Castellanos-Gonzalez A, Porrozzi R, Baldeviano GC, Lescano AG, de Los Santos MB, Fernandez OL, Saravia NG, Costa E, Melby PC, Travi BL. An Innovative Field-Applicable Molecular Test to Diagnose Cutaneous Leishmania Viannia spp. Infections. PLoS Negl Trop Dis. 2016 Apr 26;10(4):e0004638. doi: 10.1371/journal.pntd.0004638. eCollection 2016 Apr.

    PubMed 27115155

Questions about this trial

What is this clinical trial studying?

An observational study of Cutaneous Leishmaniasis (Diagnosis), run by Centro Internacional de Entrenamiento e Investigaciones Médicas at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of RPA-LF compared with the composite gold standard (smear, culture, histopathology, and q-PCR-18S) in two scenarios: reference laboratory and field. (time frame: Feb 2018 - August 2020). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04500873, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.

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