Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers

Overview

This is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples. General objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of Leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the Antigen Recognition Patterns (ARPs) of Leishmania infection in humans; to verify whether the ARPs and the new biomarkers are common to different Leishmania infantum strains isolated in Italy as well as in other part of the World and to different strains of L. donovani isolated in Sudan as well as in other part of the World and discard any possible cross reaction with other infectious diseases such as Chagas, TB, leprosy or malaria.

Interventions

• Diagnostic test In-house Western blot, specific for Leishmania
  Sample will be collected at the collaborating centres and at the DITM, if not already stored at -80°C. The samples will be delivered to the DITM. For the CONTROL groups, two serological tests for Leishmaniasis, based on different antigenic fraction, will be performed on serum samples. Different strains of Leishmania infantum and Leishmania donovani will be cultivated axenically at the DITM. Whole soluble fraction of promastigote (WSF), the whole membrane protein fraction (WMF) and the whole so

Primary outcome measures

• Biomarkers from Leishmania spp [Time frame: Baseline]

Secondary outcome measures (2)

• ARPs in different Leishmania infantum and L. donovani strains [Time frame: Baseline]
• Cross reaction [Time frame: Baseline]

Eligibility criteria

CASES:

Inclusion criteria

• Leishmania positive patient from Italy (n=30) and from Sudan (n=30);
• patient with a clinically or laboratory confirmed diagnosis of leishmaniasis;
• signed informed consent (criteria not applied in case of samples stored at the Tropica Biobank at the DITM)
• being clinically classified as leishmaniasis patient by an experienced clinician or being laboratory confirmed as leishmaniasis patients, giving positive to at least two different serological tests or to a molecular test for Leishmania sp.
• adult subjects (equal or older than 18 years)

Exclusion criteria

• lack of the necessary data and/or of biological samples
• subjects younger than 18 years

COMMUNITY CONTROLS:

Inclusion criteria

• Cryo-preserved serum samples stored at the Tropica Biobank at the DITM , IRCCS Sacro Cuore Don Calabria Hospital, Negrar (Vr), from subject from Italy (n=30) and from Africa (n=30) with no infection due by Leishmania spp.
• signed informed consent to Tropica Biobank
• adult subjects (equal or older than 18 years)
• being negative to two different serological tests for leishmaniasis

Exclusion criteria

• subjects younger than 18 years
• being positive to one serological tests for leishmaniasis.

VALIDATION CONTROLS (VC):

Inclusion criteria

• serum samples stored in Tropica Biobank at the DITM from subjects that have been clinically diagnosed with Chagas's disease, or TB, or malaria or leprosy.
• informed consent signed to Tropical Biobank
• adult subjects (equal or older than 18 years)
• being negative to two different serological tests for leishmaniasis.
• being clinically diagnosed with Chagas disease or TB, or malaria or leprosy

Exclusion criteria

• younger than 18 years
• positive result to one serological test for leishmaniasis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Italy · 1 center

• IRCCS Sacro Cuore Don Calabria hospital — Negrar

Identifiers

NCT: NCT06307171 · 2023-11

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗