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

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.

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Key information

Conditions

Schistosomiasis Helminthiasis Infections Parasitic Diseases Trematode Infections Vector Borne Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Medical Center, Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
Agreement to perform routine diagnostic procedures to diagnose schistosomiasis infection
Willing to provide a maximum of three additional blood samples in addition to routine diagnostic procedures
Able to provide informed consent

Exclusion criteria

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

Treatment and study plan

Urine CAA detection

Other

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

Primary outcomes

The sensitivity and specificity of UCP-CAA

Time frame: 12 weeks after last water contact

The 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 outcomes

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

Time frame: six weeks after praziquantel treatment

Sponsors and collaborators

Lead sponsor

Meta Roestenberg

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Jul 18, 2014
Registry last updated: Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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