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Testing Schistosomiasis Diagnostics: What Really Works?

Diagnosis of Schistosomiasis - validation and evaluation of tests

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-4wd7srr
Enrollment
200
Registered
2025-11-28
Start date
2025-01-20
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schistosomiasis mansoni

Interventions

This study is not a clinical trial This is an observational cross sectional diagnostic accuracy study with a 30-day follow up for post treatment reassessment thus there is no randomization process T
and a drop in blood pressure, dizziness, and/or fainting due to vasovagal syncope In less significant numbers, there is the risk of accidental arterial puncture and, even more frequently, infection To

Sponsors

Instituto René Rachou
Lead Sponsor
Instituto René Rachou
Collaborator

Eligibility

Age
7 Years to No maximum

Inclusion criteria

Inclusion criteria: living in an endemic area for schistosomiasis; over 7 years of age; both sexes; with or without S mansoni eggs in their feces determined by reading 18 slides of a stool sample using the Kato-Katz method

Exclusion criteria

Exclusion criteria: Participants screened as negative to Schistosoma mansoni infection who test positive for the presence of S mansoni eggs in a new stool sample collected after enrollment; Participants screened as having an active infection who report having received treatment with praziquantel between screening and study enrollment; Lactating; pregnant participants; individuals with impaired cognitive function; those unable to understand the study; Those who fail to provide one of the required biological samples

Design outcomes

Primary

MeasureTime frame
At the end of the study, it is expected to determine the accuracy of the diagnostic tests evaluated

Secondary

MeasureTime frame
At the end of the study, it is expected to find agreement between the different tests, batches and operators for the commercial tests evaluated;At the end of the study, it is expected to find the percentage of co-infection among false-positive individuals and the percentage of positivity after therapeutic cure

Countries

Brazil

Contacts

Public ContactCristina Fonseca

Instituto René Rachou

cristina.toscano@fiocruz.br+55(031)33497828

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026