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

Leishmaniasis, Visceral Clinical Trial

— VL-DX-EAFR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646981
• Other study ID #: P08002-VL-DX-EAFR
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2022
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: December 1, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral

Intervention

Device:
• Leishmania Ab Rapid Test (CTK, Biotech)
Rapid diagnostic tests to detect antibodies anti-Leishmania

Locations

Country	Name	City	State
Ethiopia	Leishmaniasis Research and Treatment Centre, Gondar University Hospital	Gondar
Kenya	Kacheliba District Hospital	Kacheliba	West Pokot

Sponsors (6)

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

Countries where clinical trial is conducted

Ethiopia,  Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to diagnosis	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.	an average of 1.5 years
Secondary	New diagnostic algorithm	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	an average of 1.5 years