Filling Key Research Gaps With Clinical Implications in Mansonellosis and Schistosomiasis: a Network Approach
- Conditions
- Schistosoma Mansoni
- Interventions
- Diagnostic Test: Molecular biology analyses
- Registration Number
- NCT06311344
- Lead Sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Biological samples Molecular biology analyses 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
- Primary Outcome Measures
Name Time Method Percentage of Schistosoma eggs 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.
Percentage of M. perstans microfilariae 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 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.
Number of M. perstans microfilariae 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 Outcome Measures
Name Time Method Identification of hybrid species of Schistosoma spp. Baseline Identification of hybrid species from each parental species of Schistosoma spp.
Percentage of samples positive for Wolbachia 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, by country of origin of the patient or most likely country of infection.
Number of samples positive for Wolbachia 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, by country of origin of the patient or most likely country of infection.
Number of samples positive for Schistosoma hybrid species 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 by country of origin of the patient or most likely country of infection.
Percentage of samples positive for Schistosoma hybrid species 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 by country of origin of the patient or most likely country of infection.
Trial Locations
- Locations (1)
IRCCS Sacro Cuore Don Calabria hospital
🇮🇹Negrar, Verona, Italy