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Detection of Schistosomiasis CAA in Travellers After High-risk Water Contact

Detection of Schistosomiasis Circulating Anodic Antigen (CAA) in Travellers After High-risk Water Contact

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02194712
Enrollment
106
Registered
2014-07-18
Start date
2015-01-31
Completion date
2019-09-30
Last updated
2020-11-18

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

Conditions

Schistosomiasis

Keywords

circulating anodic antigen

Brief summary

Schistosomiasis is increasingly encountered among travellers returning from the tropics and is known for its focal endemicity, associated with the presence of the snail intermediate host in fresh water. Because schistosomiasis in travellers is often atypical or asymptomatic due to the low intensity of infection, many infections likely go undiagnosed and will develop into chronic schistosomiasis. Conventional treatment of schistosomiasis in travellers with praziquantel 40mg/kg daily dose is known for its modest success rate. Diagnosis of schistosomiasis relies on egg detection, which has a poor sensitivity in low burden infections, or serology, which is inadequate to monitor cure. The department of parasitology of the Leiden University Medical Center has developed a novel diagnostic test based on the up-converting phosphor technology (UCP) to detect circulating anodic antigen (CAA). This test can be performed on serum and urine to detect low intensity schistosomiasis infections and confirm cure after praziquantel treatment. This study will assess the performance of UCP-CAA in travellers with high-risk water contact.

Interventions

OTHERUrine CAA detection

In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.

Sponsors

Meta Roestenberg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

1. Any self-reported high risk water contact, including wading, showering, surfing, walking along wet shore bare-footed or washing with water from a high-risk source, within 12 weeks prior to reporting to the outpatient department 2. Agreement to perform routine diagnostic procedures to diagnose schistosomiasis infection 3. Willing to provide a maximum of three additional blood samples in addition to routine diagnostic procedures 4. Able to provide informed consent

Exclusion criteria

1. Previous treatment for schistosomiasis 2. Known positive schistosomiasis serology 3. The use of immunosuppressive or immunomodulatory drugs at presentation that compromise the interpretation of schistosomiasis serology

Design outcomes

Primary

MeasureTime frameDescription
The sensitivity and specificity of UCP-CAA12 weeks after last water contactThe diagnostic performance of UCP-CAA will be assessed by calculating the sensitivity and specificity of UCP-CAA measurement in travellers 12 weeks after reported high-risk water contact. Routine diagnostics performed by the individual centers, such as serology, will be the standard against which sensitivity (number of cases positive in both tests / number of cases positive in routine diagnostics) and specificity (number of cases negative in both tests / number of cases negative in routine diagnostics) is calculated.

Secondary

MeasureTime frame
The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatmentsix weeks after praziquantel treatment

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026