Filling Key Research Gaps With Clinical Implications in Mansonellosis and Schistosomiasis: a Network Approach

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Enrolling

Conditions: Schistosoma Mansoni

Treatments: Diagnostic Test: Molecular biology analyses

Study type: Interventional

Funder types: Other

Identifiers

NCT06311344

2021-06

Details and patient eligibility

About

This is an experimental, multicenter, non-profit study promoted by the Department of Infectious and Tropical Diseases of the IRCCS (Istituto di Ricerca e Cura a carattere scientifico) Sacro Cuore Don Calabria of Negrar which aims to evaluate the presence of endosymbiont Wolbachia in circulating microfilariae obtained from biological samples of individuals infected with M .perstans and the presence of infection with hybrid Schistosoma species in the population of Schistosoma eggs isolated from biological samples of patients with active schistosomiasis.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• samples from patients who gave consent to the storage and use for research purposes of their samples. In the case a network centre necessitates a template for the storage and use for research purposes of their samples;
• samples collected before any treatment with praziquantel and/or benzimidazole and/or avermectin and/or diethylcarbamazine and/or doxycycline drug;
• samples collected and stored in conditions suitable for this study (Annex 2);
• known country of birth of the patient or of most likely infection (if different from the country of birth)

Exclusion criteria

• no compliance with at least one of the above-mentioned inclusion criteria.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Biological samples

Other group

Description:

M. perstans microfilariae and Schistosoma spp eggs, obtained from the routine diagnostic procedures carried out on patients, specifically migrants and travellers, visited in the centres participating to this study

Treatment:

Diagnostic Test: Molecular biology analyses