SchistosomiasisSchistActNCT06873308
Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis
A study testing UCP-LF CAA assay in people with Schistosomiasis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 8 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Schistosomiasis
- What is being tested?
- UCP-LF CAA assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 28 Jun 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of chronic schistosomiasis (>3 months after last potential exposure) according to site-specific diagnostic practice
- signed informed consent (and assent for minors).
Who cannot join
- age below 5 years;
- exposure to praziquantel after the last potential exposure to schistosomes
- acute infection, i.e. likely infection <3 months before presentation
Trial locations and contacts
8 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 5 countries
Italy3 sites, 3 recruiting
- Recruiting
IRCCS Policlinico Sant'Orsola
Bologna, BO
Bianca Granozzi, bianca.granozzi@aosp.bo.it
- Not yet recruiting
AOU Careggi
Florence
Lorenzo Zammarchi, lorenzo.zammarchi@unifi.it
- Recruiting
IRCCS Sacro Cuore Don Calabria
Negrar, VR, 37024
Federico Giovanni Gobbi, +39(0)456013111, federico.gobbi@sacrocuore.it
Spain2 sites, 2 recruiting
- Recruiting
Tropical Medicine Unit of Hospital de Poniente
Almería
Joaquin Salas Coronas, joaquinsalascoronas@yahoo.es
- Recruiting
Vall d'Hebron University Hospital
Barcelona
Fernando Salvador Velez, fernando.salvador@vallhebron.cat
Belgium1 site, 1 recruiting
- Recruiting
Institute of Tropical Medicine (ITM)
Antwerp
Emmanuel Bottieau, EBottieau@itg.be
Germany1 site, 1 recruiting
- Not yet recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Sabine Jordan, s.jordan@uke.de
Netherlands1 site, 1 recruiting
- Not yet recruiting
Medical Microbiology & Infectious Diseases, Erasmus MC
Rotterdam
Jaap van Hellemond, j.vanhellemond@erasmusmc.nl
About this study
Official title: Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis: a Multicentric Prospective Cohort Study
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.
Read more
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.
- Conditions
- Schistosomiasis
- Being tested
- UCP-LF CAA assay
- Keywords
- schistosomiasis, chronic, diagnosis
- Medical subject headings
- Schistosomiasis, Bronchiolitis Obliterans Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCP-LF CAA assayDevice
dry LF-CAA, or CAA
| Study group | Role | What they receive |
|---|---|---|
| Participants | Other | All eligible participants identified as having chronic schistosomiasis according to site-specific diagnostic practice will have a standardized baseline clinical and laboratory assessment at enrollment that will include blood sampling for hematology, Schistosoma serology available at each site, and PCR for Schistosoma where available; urine sampling for microscopy, determination of hematuria as indirect markers of schistosomiasis morbidity, and Schistosoma PCR (where available) and POC-CCA urine strip assay (where available); and stool sampling for microscopy and PCR where available, and fecal occult blood as indirect markers of schistosomiasis morbidity. Serum (at least 1 mL leftover from routine diagnostics) will be sent to LUMC, Netherlands, where CAA will be determined with the UCP-LF CAA assay (dry format) designed for routine use. Receives: Device: UCP-LF CAA assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active infection
Proportion of enrolled participants fulfilling the composite reference standards for active infection:
- Microscopy (Positive/Negative)
- PCR (Positive/Negative, if performed)
- CAA (Positive/Negative)
- Serology (Positive/Negative)
Measured: Baseline
Secondary outcomes (1)
CAA result
Number of enrolled participants with positive CAA result at inclusion compared to number of those fulfilling the composite reference standards active infection and of those positive by each separate diagnostic method
- Microscopy (P/N)
- PCR (P/N)
- CAA (P/N)
- Serology (P/N)
- POC-CCA (P/N)
- Signs/symptoms (eosinophilia (Y/N; eos/μL), hematuria (Y/N), fecal occult blood (Y/N), bladder mucosal lesions (Y/N, if ultrasound performed)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start28 Jun 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Federico Giovanni Gobbi, Principal investigator, IRCCS Sacro Cuore Don Calabria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873308
- Sponsor's protocol ID
- 2024-05
- Acronym
- SchistAct
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis: a Multicentric Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06873308
- Acronym / sponsor ID
- SchistAct / 2024-05
- Conditions
- Schistosomiasis
- Keywords
- schistosomiasis, chronic, diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Other | Device: UCP-LF CAA assayAll eligible participants identified as having chronic schistosomiasis according to site-specific diagnostic practice will have a standardized baseline clinical and laboratory assessment at enrollment that will include blood sampling for hematology, Schistosoma serology available at each site, and PCR for Schistosoma where available; urine sampling for microscopy, determination of hematuria as indirect markers of schistosomiasis morbidity, and Schistosoma PCR (where available) and POC-CCA urine strip assay (where available); and stool sampling for microscopy and PCR where available, and fecal occult blood as indirect markers of schistosomiasis morbidity. Serum (at least 1 mL leftover from routine diagnostics) will be sent to LUMC, Netherlands, where CAA will be determined with the UCP-LF CAA assay (dry format) designed for routine use. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of chronic schistosomiasis (>3 months after last potential exposure) according to site-specific diagnostic practice
- signed informed consent (and assent for minors).
Key exclusion criteria (3 listed)
- age below 5 years;
- exposure to praziquantel after the last potential exposure to schistosomes
- acute infection, i.e. likely infection <3 months before presentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCP-LF CAA assaydry LF-CAA, or CAA | Device | Participants |
Primary outcome
Active infection
Time frame: Baseline
Proportion of enrolled participants fulfilling the composite reference standards for active infection: * Microscopy (Positive/Negative) * PCR (Positive/Negative, if performed) * CAA (Positive/Negative) * Serology (Positive/Negative)
1 secondary outcome
CAA result
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federico Giovanni Gobbi principal investigator
IRCCS Sacro Cuore Don Calabria
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UCP-LF CAA assay in people with Schistosomiasis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Spain, Belgium, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo (+390456013111, ricerca.clinica@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active infection (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.