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

Completed

• Conditions: Schistosomiasis
• Interventions: Other: Urine CAA detection

• Registration Number: NCT02194712
• Lead Sponsor: Meta Roestenberg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-18
• Study Start: 2015-01
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
travellers	Urine CAA detection	travellers with recent (\<12 weeks) high risk water contact are included in the study and asked to provide samples for CAA testing

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of UCP-CAA	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 Outcome Measures

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

Trial Locations

Locations (3)

Harbour Hospital; 🇳🇱 Rotterdam, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands