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

NCT06873308 | Recruiting

• 1 other identifier: 2024-05
• Study Type: interventional
• Target: 278
• Locations: 5 countries
• Sites: 8

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.

Conditions

Schistosomiasis

Keywords

schistosomiasis; chronic; diagnosis

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline

Secondary Outcomes (1)

• CAA result

  Baseline

Other Outcomes (1)

• CAA cure

  At week 6 post-treatment

Study Arms (1)

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.

Device: UCP-LF CAA assay

Interventions

UCP-LF CAA assay DEVICE

dry LF-CAA, or CAA

Participants

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead
• Leiden University Medical Center (LUMC): collaborator

Study Sites (8)

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, 37024, 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

MeSH Terms

Conditions

Schistosomiasis; Bronchiolitis Obliterans Syndrome; Disease

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Federico Giovanni Gobbi

  IRCCS Sacro Cuore Don Calabria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elvia Malo

CONTACT

+390456013111; ricerca.clinica@sacrocuore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: June 28, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

ES (2); NL (1); DE (1); IT (3); BE (1)