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

Recruiting now · Not applicable

Conditions studied: Schistosomiasis

In brief

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.

Key facts

Study ID

NCT06873308

Run by

IRCCS Sacro Cuore Don Calabria di Negrar

People needed

278

Starts

2024-06-28

Expected to finish

2027-01-01

Last updated by the study team

2025-04-20

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Institute of Tropical Medicine (ITM) — Antwerp, Belgium (enrolling)
• IRCCS Sacro Cuore Don Calabria — Negrar, VR, Italy (enrolling)
• Tropical Medicine Unit of Hospital de Poniente — Almería, Spain (enrolling)
• Vall d'Hebron University Hospital — Barcelona, Spain (enrolling)
• IRCCS Policlinico Sant'Orsola — Bologna, BO, Italy (enrolling)
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
• AOU Careggi — Florence, Italy
• Medical Microbiology & Infectious Diseases, Erasmus MC — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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