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

NCT ID: NCT03646981

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 704 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-12-01

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.

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 Ethiopia, 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

Conditions

Leishmaniasis, Visceral

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Leishmania Ab Rapid Test (CTK, Biotech)

Rapid diagnostic tests to detect antibodies anti-Leishmania

Intervention Type: DEVICE

Other Intervention Names

IT Leish (Bio Rad); IgG1 RDT (Coris BioConcept)

Eligibility 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).

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Gondar

OTHER

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

Drugs for Neglected Diseases

OTHER

Sponsor Role: collaborator

Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Israel Cruz, PhD

Role: PRINCIPAL_INVESTIGATOR

Find

Locations

Leishmaniasis Research and Treatment Centre, Gondar University Hospital

Gonder, , Ethiopia

Kacheliba District Hospital

Kacheliba, West Pokot County, Kenya

Countries

Ethiopia; Kenya

Other Identifiers

P08002-VL-DX-EAFR

Identifier Type: -

Identifier Source: org_study_id