Brief Title
Detection of Schistosomiasis CAA in Travellers After High-risk Water Contact
Official Title
Detection of Schistosomiasis Circulating Anodic Antigen (CAA) in Travellers After High-risk Water Contact
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.
Study Type
Observational
Primary Outcome
The sensitivity and specificity of UCP-CAA
Secondary Outcome
The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment
Condition
Schistosomiasis
Intervention
Urine CAA detection
Study Arms / Comparison Groups
travellers
Description: travellers with recent (<12 weeks) high risk water contact are included in the study and asked to provide samples for CAA testing
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
106
Start Date
January 2015
Completion Date
September 2019
Primary Completion Date
September 2019
Eligibility Criteria
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
Gender
All
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
M.P. Grobusch, Prof. MD. PhD, ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT02194712
Organization ID
CAA48780
Responsible Party
Sponsor-Investigator
Study Sponsor
Meta Roestenberg
Study Sponsor
M.P. Grobusch, Prof. MD. PhD, Principal Investigator, VU University Medical Center
Verification Date
November 2020