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

Last updated: April 16, 2025
Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

UCP-LF CAA assay

Clinical Study ID

NCT06873308
2024-05
  • Ages > 5
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion criteria

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

  2. signed informed consent (and assent for minors).

Exclusion criteria

  1. age below 5 years;

  2. exposure to praziquantel after the last potential exposure to schistosomes

  3. acute infection, i.e. likely infection <3 months before presentation

Study Design

Total Participants: 278
Treatment Group(s): 1
Primary Treatment: UCP-LF CAA assay
Phase:
Study Start date:
June 28, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Institute of Tropical Medicine (ITM)

    Antwerp,
    Belgium

    Active - Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg,
    Germany

    Site Not Available

  • IRCCS Policlinico Sant'Orsola

    Bologna, BO
    Italy

    Active - Recruiting

  • IRCCS Sacro Cuore Don Calabria

    Negrar di Valpolicella, VR 37024
    Italy

    Active - Recruiting

  • AOU Careggi

    Firenze,
    Italy

    Site Not Available

  • Medical Microbiology & Infectious Diseases, Erasmus MC

    Rotterdam,
    Netherlands

    Site Not Available

  • Tropical Medicine Unit of Hospital de Poniente

    Almería,
    Spain

    Active - Recruiting

  • Vall d'Hebron University Hospital

    Barcelona,
    Spain

    Active - Recruiting

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