NCT06873308 Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis
| NCT ID | NCT06873308 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar |
| Condition | Schistosomiasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 278 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 278 participants in total. It began in 2024-06-28 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Federico Giovanni Gobbi
PRINCIPAL INVESTIGATOR
IRCCS Sacro Cuore Don Calabria
Frequently Asked Questions
Who can join the NCT06873308 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Schistosomiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06873308 currently recruiting?
Yes, NCT06873308 is actively recruiting participants. Contact the research team at ricerca.clinica@sacrocuore.it for enrollment information.
Where is the NCT06873308 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Hamburg, Germany, Bologna, Italy, Negrar, Italy and 4 additional locations.
Who is sponsoring the NCT06873308 clinical trial?
NCT06873308 is sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. The principal investigator is Federico Giovanni Gobbi at IRCCS Sacro Cuore Don Calabria. The trial plans to enroll 278 participants.