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

NCT06311344 | Recruiting

• 1 other identifier: 2021-06
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schistosoma Mansoni

Outcome Measures

Primary Outcomes (4)

• Number of M. perstans microfilariae

  Number of samples, defined as the whole M. perstans microfilariae retrieved from one blood sample from each patient, positive for the presence of Wolbachia as assessed by PCR.

  Baseline

• Percentage of M. perstans microfilariae

  Percentage of samples, defined as the whole M. perstans microfilariae retrieved from one blood sample from each patient, positive for the presence of Wolbachia as assessed by PCR.

  Baseline

• Number of Schistosoma eggs

  Number of samples defined as the whole Schistosoma eggs retrieved from one stool or urine sample from each patient, positive for the presence Schistosoma hybrid species.

  Baseline

• Percentage of Schistosoma eggs

  Percentage of samples defined as the whole Schistosoma eggs retrieved from one stool or urine sample from each patient, positive for the presence Schistosoma hybrid species.

  Baseline

Secondary Outcomes (5)

• Number of samples positive for Wolbachia

  Baseline

• Percentage of samples positive for Wolbachia

  Baseline

• Number of samples positive for Schistosoma hybrid species

  Baseline

• Percentage of samples positive for Schistosoma hybrid species

  Baseline

• Identification of hybrid species of Schistosoma spp.

  Baseline

Study Arms (1)

Biological samples

OTHER

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

Diagnostic Test: Molecular biology analyses

Interventions

Molecular biology analyses DIAGNOSTIC_TEST

Samples of M. perstans microfilariae will be processed by PCR to investigate the presence (or absence) of Wolbachia using a set of primers targeting the genes ftsZ and 16S and optimized using reference material during the first year of the study. Samples of Schistosoma eggs from urine and feces will be processed for DNA extraction. Each sample will be genetically characterised by multi locus analysis of the mitochondrial cox1 region and the nuclear ITS and 18S rRNA regions. PCR products will be analysed by agarose gel electrophoresis and selected amplicons will be purified and Sanger sequenced. For the individuation of Schistosoma hybrids, the nuclear DNA for each sample will be confirmed by analysis of the species-specific polymorphic positions of the ITS1+2 and 18S. The mitochondrial and nuclear DNA genetic profiles for each individual sample will be recorded to determine the species involved in the infections and also any hybrid schistosomes

Biological samples

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, 37024, Italy

RECRUITING

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 15, 2024
• Study Start: April 14, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

IT (1)