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Recruiting NCT06873308

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

No phase Interventional Schistosomiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UCP-LF CAA assay.
Who it may be relevant to
Registry conditions: Schistosomiasis. Basic parameters: from 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Germany, Italy, Netherlands, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis: a Multicentric Prospective Cohort Study

Overview

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.

Interventions

  • Device UCP-LF CAA assay
    dry LF-CAA, or CAA

Primary outcome measures

  • Active infection [Time frame: Baseline]
Secondary outcome measures (1)
  • CAA result [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Italy · 3 centers
  • IRCCS Policlinico Sant'Orsola — Bologna
  • IRCCS Sacro Cuore Don Calabria — Negrar
  • AOU Careggi — Florence
Spain · 2 centers
  • Tropical Medicine Unit of Hospital de Poniente — Almería
  • Vall d'Hebron University Hospital — Barcelona
Belgium · 1 center
  • Institute of Tropical Medicine (ITM) — Antwerp
Germany · 1 center
  • Universitätsklinikum Hamburg-Eppendorf — Hamburg
Netherlands · 1 center
  • Medical Microbiology & Infectious Diseases, Erasmus MC — Rotterdam

Identifiers

NCT: NCT06873308 · 2024-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗