A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis

NCT04342715 | Active Not Recruiting DMC

• 2 other identifiers: ImmStat@Cure (PK202001)RIA2016V-1640
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

ImmStat@Cure is a multicentre observational study designed to assess the immune status of patients before and after treatment for visceral leishmaniasis. Forty patients and 30 controls will be recruited per site. The follow-up period is 6 months from the end of treatment.

Conditions

Visceral Leishmaniasis

Outcome Measures

Primary Outcomes (2)

• Immune cell phenotypes present in peripheral blood and tissue

  Identification of immune cell phenotypes present in peripheral blood and tissue before and after treatment for VL.

  36 months

• Parasite load in skin

  Identification of parasite load in skin biopsies from patients with VL

  36 months

Secondary Outcomes (2)

• Parasite genotype

  36 months

• Immunological and parasitological data across sites

  36 months

Study Arms (2)

Patients

Patients who have a diagnosis of visceral leishmaniasis and will be treated with SSG/PM

Drug: Sodium stibogluconate / paramomycin

Control

Healthy volunteers

Interventions

Sodium stibogluconate / paramomycin DRUG

Treatment with Sodium stibogluconate / paramomycin

Patients

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a confirmed diagnosis of VL and judged suitable for standard treatment regimen of SSG/PM.Patients will be recruited by active case detection. Controls will be recruited using convenient sampling method.

You may qualify if:

• Aged 12 to 50 years on the day of diagnosis
• Have confirmed diagnosis of VL and be judged suitable for treatment using a standard regimen of SSG/PM
• Willing and able to give written informed consent
• For adolescents aged 12 to 17 years on the day of screening, written informed consent from a parent must be obtained in addition to assent from the patient
• Without any other significant health problems as determined by medical history, physical examination, results of screening tests and the clinical judgment of a medically qualified Clinical Investigator
• Negative for malaria on blood smear
• Judged, in the opinion of a medically qualified Clinical Investigator, to be able and likely to comply with all study requirements as set out in the protocol

You may not qualify if:

• The patient may not enter the study if any of the following apply:
• Has HIV, HBV or HBC
• Has previously had any form of leishmaniasis
• Pregnancy or lactating mothers
• Any confirmed or suspected immunosuppressive or immunodeficient state, including; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months
• Tuberculosis, leprosy, or severe malnutrition (severe malnutrition in adults defined as a BMI \<18.5, and in adolescents (12-17yrs) as a Z score cut-off value of \<-2 SD)
• Any other significant disease, disorder or finding, which, in the opinion of a medically qualified Clinical Investigator, may influence the result of the study, or the volunteer's ability to participate in the study
• Unlikely to comply with the study protocol

Sponsors & Collaborators

• University of York: lead
• University of Gondar: collaborator
• Kenya Medical Research Institute: collaborator
• Makerere University: collaborator
• University of Khartoum: collaborator
• European Vaccine Initiative: collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (1)

KEMRI

Nairobi, Kenya

Location

Biospecimen

Retention: SAMPLES WITH DNA

3mm skin biopsies whole blood diagnostic residue tissue aspirates (bone marrow, spleen or lymph node according to local procedures)

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

Antimony Sodium Gluconate; Paromomycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Aminoglycosides; Glycosides

Study Officials

• Paul Kaye, PhD

  University of York

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Immunology

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: May 22, 2022
• Primary Completion: May 31, 2025
• Study Completion: March 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)