Clinical trial NCT03646981: Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa
Official title: Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leishmaniasis, Visceral
Keywords: visceral leishmaniasis
diagnostics
RDT
Eastern Africa
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Gondar
name: Kenya Medical Research Institute
name: London School of Hygiene and Tropical Medicine
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Drugs for Neglected Diseases
First posted: 2018-08-24
Enrollment: 704
Sex: ALL
Minimum age (years): 4
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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).

Primary outcomes:
measure: RDT performance
timeFrame: an average of 1.5 years
Secondary outcomes:
measure: Time to diagnosis
timeFrame: an average of 1.5 years
measure: New diagnostic algorithm
timeFrame: an average of 1.5 years
Other outcomes:
Locations:
city: Gondar
country: Ethiopia
facility: Leishmaniasis Research and Treatment Centre, Gondar University Hospital
city: Kacheliba
country: Kenya
facility: Kacheliba District Hospital
state: West Pokot
Study officials:
affiliation: Find
name: Israel Cruz, PhD
role: PRINCIPAL_INVESTIGATOR
References: