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

Schistosomiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194712
• Other study ID #: CAA48780
• Status: Completed
• Start date: January 2015
• Est. completion date: September 2019

Study information

• Verified date: November 2020
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Schistosomiasis

Intervention

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

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Harbour Hospital	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Meta Roestenberg

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Casacuberta-Partal M, Janse JJ, van Schuijlenburg R, de Vries JJC, Erkens MAA, Suijk K, van Aalst M, Maas JJ, Grobusch MP, van Genderen PJJ, de Dood C, Corstjens PLAM, van Dam GJ, van Lieshout L, Roestenberg M. Antigen-based diagnosis of Schistosoma infec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of UCP-CAA	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.	12 weeks after last water contact
Secondary	The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment		six weeks after praziquantel treatment