RecruitingNot ApplicableNCT06873308

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

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


Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Enrollment

278 participants

Start Date

Jun 28, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 Years

Inclusion Criteria2

  • diagnosis of chronic schistosomiasis (>3 months after last potential exposure) according to site-specific diagnostic practice
  • signed informed consent (and assent for minors).

Exclusion Criteria3

  • age below 5 years;
  • exposure to praziquantel after the last potential exposure to schistosomes
  • acute infection, i.e. likely infection <3 months before presentation

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Interventions

DEVICEUCP-LF CAA assay

dry LF-CAA, or CAA


Locations(8)

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

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NCT06873308


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