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Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis

NCT06873308 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2025-04-20

No results posted yet for this study

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.

Conditions

  • Schistosomiasis

Interventions

DEVICE

UCP-LF CAA assay

dry LF-CAA, or CAA

Sponsors & Collaborators

  • Leiden University Medical Center (LUMC)

    collaborator UNKNOWN

  • IRCCS Sacro Cuore Don Calabria di Negrar

    lead OTHER

Principal Investigators

  • Federico Giovanni Gobbi · IRCCS Sacro Cuore Don Calabria

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-28
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Belgium
  • Germany
  • Italy
  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873308 on ClinicalTrials.gov