Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis
NCT ID: NCT06873308
Last Updated: 2025-04-20
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
278 participants
INTERVENTIONAL
2024-06-28
2027-01-31
Brief Summary
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All subjects with chronic schistosomiasis according to site-specific diagnostic practice will have a standardized baseline clinical and laboratory evaluation at the time of evaluation that will include blood sampling for hematology, schistosome serology available at each site, and schistosome PCR where available; urine sampling for microscopy, determination of hematuria as an indirect marker of morbidity for schistosomiasis, and Schistosome PCR (where available), and urine strip testing POC-CCA (where available); and stool sampling for microscopy and PCR, where available, and fecal occult blood as indirect markers of schistosomiasis morbidity.
Composite reference standards will be used to assess and classify the activity of the infection. Organ-specific ultrasound and other tests will be left to the physician's decision, but results will also be collected.
Serum (at least 1 ml remaining from routine diagnostics) will be sent to LUMC, the Netherlands, where CAA will be determined with the UCP-LF CAA test designed for routine use.
Participants will be asked to sign an additional consent form, which is optional and not precluding enrollment in the study, to allow the remaining serum to be stored at LUMC for 15 years, to allow secondary research.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Participants
All eligible participants identified as having chronic schistosomiasis according to site-specific diagnostic practice will have a standardized baseline clinical and laboratory assessment at enrollment that will include blood sampling for hematology, Schistosoma serology available at each site, and PCR for Schistosoma where available; urine sampling for microscopy, determination of hematuria as indirect markers of schistosomiasis morbidity, and Schistosoma PCR (where available) and POC-CCA urine strip assay (where available); and stool sampling for microscopy and PCR where available, and fecal occult blood as indirect markers of schistosomiasis morbidity. Serum (at least 1 mL leftover from routine diagnostics) will be sent to LUMC, Netherlands, where CAA will be determined with the UCP-LF CAA assay (dry format) designed for routine use.
UCP-LF CAA assay
dry LF-CAA, or CAA
Interventions
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UCP-LF CAA assay
dry LF-CAA, or CAA
Eligibility Criteria
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Inclusion Criteria
2. signed informed consent (and assent for minors).
Exclusion Criteria
2. exposure to praziquantel after the last potential exposure to schistosomes
3. acute infection, i.e. likely infection \<3 months before presentation
5 Years
ALL
No
Sponsors
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Leiden University Medical Center (LUMC)
UNKNOWN
IRCCS Sacro Cuore Don Calabria di Negrar
OTHER
Responsible Party
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Principal Investigators
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Federico Giovanni Gobbi
Role: PRINCIPAL_INVESTIGATOR
IRCCS Sacro Cuore Don Calabria
Locations
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Institute of Tropical Medicine (ITM)
Antwerp, , Belgium
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
IRCCS Policlinico Sant'Orsola
Bologna, BO, Italy
IRCCS Sacro Cuore Don Calabria
Negrar, VR, Italy
AOU Careggi
Florence, , Italy
Medical Microbiology & Infectious Diseases, Erasmus MC
Rotterdam, , Netherlands
Tropical Medicine Unit of Hospital de Poniente
Almería, , Spain
Vall d'Hebron University Hospital
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-05
Identifier Type: -
Identifier Source: org_study_id
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