Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis: a Multicentric Prospective Cohort Study

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary objective of this clinical investigation is to determine the percentage of travelers and migrants diagnosed with chronic schistosomiasis according to site-specific diagnostic practice who have active infection at the time of evaluation (as assessed and classified by composite reference standards that integrate clinical, laboratory, and diagnostic features, such as microscopy, PCR (where available), POC-CCA (where available), and serum CAA results). 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: f
View:

• diagnosis of chronic schistosomiasis (\>3 months after last potential exposure) according to site-specific diagnostic practice

• signed informed consent (and assent for minors).

Locations
Other Locations
Belgium
Institute of Tropical Medicine (ITM)
RECRUITING
Antwerp
Germany
Universitätsklinikum Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
Italy
IRCCS Policlinico Sant'Orsola
RECRUITING
Bologna
AOU Careggi
NOT_YET_RECRUITING
Florence
IRCCS Sacro Cuore Don Calabria
RECRUITING
Negrar Di Valpolicella
Netherlands
Medical Microbiology & Infectious Diseases, Erasmus MC
NOT_YET_RECRUITING
Rotterdam
Spain
Tropical Medicine Unit of Hospital de Poniente
RECRUITING
Almería
Vall d'Hebron University Hospital
RECRUITING
Barcelona
Contact Information
Primary
Elvia Malo
ricerca.clinica@sacrocuore.it
+390456013111
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2027-01
Participants
Target number of participants: 278
Treatments
Other: 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.
Sponsors
Collaborators: Leiden University Medical Center (LUMC)
Leads: IRCCS Sacro Cuore Don Calabria di Negrar

This content was sourced from clinicaltrials.gov

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