Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa

NCT03646981 | Completed

• 1 other identifier: P08002-VL-DX-EAFR
• Study Type: observational
• Target: 704
• Locations: 2 countries
• Sites: 2

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.

Conditions

Leishmaniasis, Visceral

Keywords

visceral leishmaniasis; diagnostics; RDT; Eastern Africa

Outcome Measures

Primary Outcomes (1)

• RDT performance

  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

  an average of 1.5 years

Secondary Outcomes (2)

• Time to diagnosis

  an average of 1.5 years

• New diagnostic algorithm

  an average of 1.5 years

Interventions

Leishmania Ab Rapid Test (CTK, Biotech) DEVICE

Rapid diagnostic tests to detect antibodies anti-Leishmania

Also known as: IT Leish (Bio Rad), IgG1 RDT (Coris BioConcept)

Eligibility Criteria

• Age: 4 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• University of Gondar: collaborator
• Kenya Medical Research Institute: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Drugs for Neglected Diseases: collaborator

Study Sites (2)

Leishmaniasis Research and Treatment Centre, Gondar University Hospital

Gonder, PO BOX 196, Ethiopia

Location

Kacheliba District Hospital

Kacheliba, West Pokot County, P.O Box 50 Kacheliba 30601, Kenya

Location

MeSH Terms

Conditions

Leishmaniasis, Visceral

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Israel Cruz, PhD

  Find

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 24, 2018
• Study Start: September 1, 2019
• Primary Completion: October 30, 2021
• Study Completion: December 1, 2021
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

ET (1); KE (1)