Filling Key Research Gaps With Clinical Implications in Mansonellosis and Schistosomiasis: a Network Approach
NCT ID: NCT06311344
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2021-04-14
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Biological samples
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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)
ALL
No
Sponsors
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IRCCS Sacro Cuore Don Calabria di Negrar
OTHER
Responsible Party
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Locations
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IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, Italy
Countries
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Facility Contacts
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Other Identifiers
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2021-06
Identifier Type: -
Identifier Source: org_study_id
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