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Clinical Trials/NCT06311344
NCT06311344
Recruiting
Not Applicable

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

IRCCS Sacro Cuore Don Calabria di Negrar1 site in 1 country200 target enrollmentApril 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schistosoma Mansoni
Sponsor
IRCCS Sacro Cuore Don Calabria di Negrar
Enrollment
200
Locations
1
Primary Endpoint
Percentage of M. perstans microfilariae
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 14, 2021
End Date
March 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
IRCCS Sacro Cuore Don Calabria di Negrar
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Percentage of M. perstans microfilariae

Time Frame: Baseline

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.

Number of Schistosoma eggs

Time Frame: Baseline

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.

Percentage of Schistosoma eggs

Time Frame: Baseline

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.

Number of M. perstans microfilariae

Time Frame: Baseline

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.

Secondary Outcomes

  • Identification of hybrid species of Schistosoma spp.(Baseline)
  • Percentage of samples positive for Wolbachia(Baseline)
  • Number of samples positive for Wolbachia(Baseline)
  • Number of samples positive for Schistosoma hybrid species(Baseline)
  • Percentage of samples positive for Schistosoma hybrid species(Baseline)

Study Sites (1)

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