Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure

NCT05426577 | Unknown

• 1 other identifier: VL-ToC-AfriKADIA
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Left untreated, visceral leishmaniasis (VL) is fatal. The highest burden of VL worldwide is in eastern Africa where field-adapted diagnostic and test-of-cure tools and treatment are lacking. The current laboratory tool to help assessing cure, treatment failure and relapse is microscopy, based on invasive sampling (e.g. splenic or bone marrow aspirate). Non-invasive, more sensitive tools will enable these assessments with minimum risk and discomfort to patients. This study aims to evaluate immunological and molecular tests to predict cure and relapse, and to replace with these the current invasive methods. The study will be conducted at the Leishmaniasis Research and Treatment Centre (LRTC), Gondar University Hospital, Ethiopia It will be a non-intervention study, the tools under evaluation will be considered as index tests; their results will not influence patient management during the duration of the study. Patient management will follow the national guidelines for VL diagnosis and management in Ethiopia.

Conditions

Visceral Leishmaniasis

Keywords

leishmania; leishmaniasis; kala azar

Outcome Measures

Primary Outcomes (2)

• To assess the diagnostic performance of the immunological tests under evaluation for predicting cure and treatment failure at end-of-treatment assessment

  Sensitivity, specificity, positive and negative predictive values will be reported

  At 6 month follow up

• To assess the diagnostic performance of the molecular tests under evaluation for predicting cure and treatment failure at end-of-treatment assessment

  Sensitivity, specificity, positive and negative predictive values will be reported

  At 6 month follow up

Secondary Outcomes (2)

• To assess the diagnostic performance of the immunological tests under evaluation for predicting cure, treatment failure and relapse during follow-up

  17 days from treatment start

• To assess the diagnostic performance of the molecular tests under evaluation for predicting cure, treatment failure and relapse during follow-up

  17 days from treatment start

Interventions

ELISA, LAMP, Cytokine Release Assay DIAGNOSTIC_TEST

IgG1 ELISA: ELISA that employs soluble Leishmania lysate or protein antigen.Results are recorded as antibody titres, which are measured by the absorbance values of products generated using enzyme conjugated anti-human antibodies. Cytokine release assay (CRA): In this assay whole blood is stimulated for 24 hours with leishmania antigen. Cytokine levels are then assessed in the plasma fraction using flow cytometry with the BD™ Cytometric Bead Array for Human Cytokines or standard ELISA kits for human cytokines commercialized by Sigma-Aldrich (RAB0268-IL-2, RAB0222-IFN-g, RAB0224-IL-10, RAB0476-TNF-a, RAB0119-IP-10). LAMP test for VL: We will use the LoopampTM Leishmania Detection Kit, CE-marked and produced Eiken Chemical Co., Japan.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary VL patients, admitted for treatment at the Leishmaniasis Research and Treatment Centre, Gondar University Hospital, with current standard combination therapy in eastern Africa (SSG+PM). A total of 60 VL patients is the target.

You may qualify if:

• Patients with clinical signs and symptoms of VL and confirmatory parasitological microscopic diagnosis.
• Patients for whom written informed consent has been obtained (if aged 18 years and over) or signed by parents(s) or legal guardian for patients under 18 years of age (in the case of minors, assent from the children also needs to be obtained as per country regulatory requirements).

You may not qualify if:

• Patients who are cases of VL relapse, post- or para-kala-azar dermal leishmaniasis or who have received any anti-leishmanial drugs within the last six months.
• Patients not eligible for treatment with SSG+PM:
• Patients with severe malnutrition.
• Patients with positive HIV diagnosis.
• Patients with previous history of hypersensitivity reaction or known drug class allergy to any of the study treatments (SSG or PM).
• Patients with previous history of cardiac arrhythmia or with a clinically significant abnormal ECG.
• Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic), or chronic condition which would preclude evaluation of the patient's response to study medication.
• Patients who cannot comply with the planned procedures and scheduled visits of the study protocol.

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Leishmaniasis Research and Treatment Cener University of Gondar, Ethiopia: collaborator
• WHO Collaborating Centre for Leishmaniasis, INstituto de Salud Carlos III, Spain: collaborator
• University of Amsterdam Medical Center, Netherlands: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Leishmaniasis Research and Treatment Centre, Gondar University Hospital

Gonder, PO BOX 196, Ethiopia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Leishmaniasis, Visceral; Leishmaniasis

Interventions

Light

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Design

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

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 22, 2022
• Study Start: September 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

ET (1)