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Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa (VL-DX-EAFR)

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ClinicalTrials.gov Identifier: NCT03646981
Recruitment Status : Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
University of Gondar
Kenya Medical Research Institute
University of Khartoum
Makerere University
London School of Hygiene and Tropical Medicine
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Drugs for Neglected Diseases
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Brief Summary:
According to recent estimates by the World Health Organization (WHO) on eastern Africa, not all visceral leishmaniasis (VL) cases reported are confirmed by a laboratory test, probably due to limited access to accurate diagnostic tests and poor reporting. The main approach for VL diagnosis involves antibody detection using the rK39 rapid diagnostic test (RDT) and alternatively the direct agglutination test (DAT) to confirm clinically suspected cases. Suspected cases with negative rK39 RDT and/or DAT results are referred to facilities where examination of tissue aspirate (spleen, bone marrow, lymph node) by microscopy is available. Unfortunately, the diagnostic performance of rK39 in eastern Africa is suboptimal, particularly in settings with a high VL/HIV co-infection rate. A recently developed RDT, based on the recombinant antigen rK28, may overcome this problem, with studies reporting better performance than the rK39. However, data are not definitive, as studies comparing rK28 RDTs with rK39 RDT are limited. Another recently developed RDT detects immunoglobulin G1 (IgG1) specific to Leishmania and has shown promising results in the Indian subcontinent. This study aims to undertake a multi-country assessment of the performance of rK28 and IgG1 RDTs, as compared to the currently used rK39 RDT.

Condition or disease Intervention/treatment
Leishmaniasis, Visceral Device: Leishmania Ab Rapid Test (CTK, Biotech)

Detailed Description:

Primary objective and endpoint: To evaluate the performance of different diagnostic tests in detecting anti-Leishmania antibodies to improve early diagnosis of VL in eastern Africa, in particular Sudan, Ethiopia, Uganda and Kenya. Evaluation of the diagnostic performance of the RDTs for primary VL diagnosis based on estimates of sensitivity, specificity, positive and negative predictive values, as well as the degree of agreement between tests.

Design: Prospective single arm diagnostic accuracy study. Multicountry. With participants being suspected cases of VL


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Study Type : Observational
Estimated Enrollment : 1684 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis


Intervention Details:
  • Device: Leishmania Ab Rapid Test (CTK, Biotech)
    Rapid diagnostic tests to detect antibodies anti-Leishmania
    Other Names:
    • IT Leish (Bio Rad)
    • IgG1 RDT (Coris BioConcept)


Primary Outcome Measures :
  1. RDT performance [ Time Frame: an average of 1.5 years ]
    Evaluation of the diagnostic performance of the RDTs for primary VL diagnosis based on estimates of sensitivity, specificity, positive and negative predictive values, as well as the degree of agreement between tests


Secondary Outcome Measures :
  1. Time to diagnosis [ Time Frame: an average of 1.5 years ]
    Time taken to perform each diagnostic test, measured from the time the patient reports at the health facility to the time diagnosis is made is established.

  2. New diagnostic algorithm [ Time Frame: an average of 1.5 years ]
    The data generated will be analysed to assess whether the evaluated RDTs can be combined in a new algorithm to improve and accelerate VL diagnosis



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient reporting to the participating VL treatment centres in Ethiopia, Kenya, Sudan and Uganda and suspected with primary VL is eligible for inclusion in the study.
Criteria

Inclusion Criteria:

  • Patient with clinical signs compatible with VL.
  • Is a first VL episode suspected.
  • Patient ≥ 5 years old (≥ 4 years old in Kenya).
  • Patient from whom written informed consent can be obtained or signed by parent or legal guardian if patient is under 18 years of age. In the case of minors, assent from the children (12-17 years old in Ethiopia, Uganda and Sudan, and 13-17 years old in Kenya) will be obtained, as per country legal requirements.
  • Clinical samples required VL diagnosis (peripheral blood, lymph node or bone marrow or spleen aspirate) can be obtained from the patient and patient shows willingness.

Exclusion Criteria:

  • Patient already on treatment for VL.
  • Patient is a suspected VL relapse case.
  • Patient has had previous VL episodes.
  • Patients < 5 years old (< 4 years old in Kenya).
  • Pregnant woman.
  • Patient has post/para-kala-azar dermal leishmaniasis (PKDL).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646981


Contacts
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Contact: Israel Cruz, PhD +41 227100954 isra.cruz@finddx.org
Contact: Albert Picado, PhD +41 227102789 albert.picado@finddx.org

Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
University of Gondar
Kenya Medical Research Institute
University of Khartoum
Makerere University
London School of Hygiene and Tropical Medicine
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Drugs for Neglected Diseases
Investigators
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Principal Investigator: Israel Cruz, PhD Find

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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT03646981     History of Changes
Other Study ID Numbers: P08002-VL-DX-EAFR
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sharing procedures (including data confidentiality) will be carried out in accordance with the regulations defined by IDDO and H2020 Open Research Data Pilot

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Foundation for Innovative New Diagnostics, Switzerland:
visceral leishmaniasis
diagnostics
RDT
Eastern Africa

Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs