Evaluating active schistosomiasis infections in travelers and migrants
Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis: a Multicentric Prospective Cohort Study
This study is trying to find out how many travelers and migrants with chronic schistosomiasis still have active infections by using various tests and evaluations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 278 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar Academic / other |
| Locations | 8 sites (Antwerp and 7 other locations) |
| Trial ID | NCT06873308 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess the percentage of travelers and migrants diagnosed with chronic schistosomiasis who have active infections at the time of evaluation. The study employs a comprehensive diagnostic approach that includes clinical assessments, laboratory tests, and diagnostic features such as microscopy and PCR. Participants will undergo standardized evaluations, including blood and urine sampling, to determine the presence of active infection. The findings will help improve diagnostic practices for schistosomiasis in affected populations.
Who should consider this trial
Good fit: Ideal candidates for this study are travelers and migrants diagnosed with chronic schistosomiasis for more than three months.
Not a fit: Patients under the age of five or those who have had recent exposure to praziquantel or acute infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing active schistosomiasis infections, leading to better treatment outcomes for patients.
How similar studies have performed: Other studies have shown success in using similar diagnostic approaches for schistosomiasis, indicating potential for effective outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Antwerp and 7 other locations
- Institute of Tropical Medicine (ITM) — Antwerp, Belgium (Recruiting)
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Not_yet_recruiting)
- IRCCS Policlinico Sant'Orsola — Bologna, Bo, Italy (Recruiting)
- IRCCS Sacro Cuore Don Calabria — Negrar, Vr, Italy (Recruiting)
- AOU Careggi — Florence, Italy (Not_yet_recruiting)
- Medical Microbiology & Infectious Diseases, Erasmus MC — Rotterdam, Netherlands (Not_yet_recruiting)
- Tropical Medicine Unit of Hospital de Poniente — Almería, Spain (Recruiting)
- Vall d'Hebron University Hospital — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Federico Giovanni Gobbi — IRCCS Sacro Cuore Don Calabria
- Study coordinator: Elvia Malo
- Email: ricerca.clinica@sacrocuore.it
- Phone: +390456013111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.