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

Schistosoma Mansoni Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311344
• Other study ID #: 2021-06
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2024
• Source: IRCCS Sacro Cuore Don Calabria di Negrar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Mansonelliasis
• Schistosoma Mansoni
• Schistosomiasis

Intervention

Diagnostic Test:
• Molecular biology analyses
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

Locations

Country	Name	City	State
Italy	IRCCS Sacro Cuore Don Calabria hospital	Negrar	Verona

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Number of samples positive for Wolbachia	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.	Baseline
Secondary	Percentage of samples positive for Wolbachia	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.	Baseline
Secondary	Number of samples positive for Schistosoma hybrid species	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.	Baseline
Secondary	Percentage of samples positive for Schistosoma hybrid species	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.	Baseline
Secondary	Identification of hybrid species of Schistosoma spp.	Identification of hybrid species from each parental species of Schistosoma spp.	Baseline