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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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.

Detailed Summary:
Sponsor: MetaRoestenberg

Current Primary Outcome: 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.


Original Primary Outcome: The sensitivity and specificity of UCP-CAA measurement in travellers 12 weeks after reported high-risk water contact as compared to gold standard routine diagnostics. [ 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 gold standard against which sensitivity (number of cases positive in both tests / number of cases positive in gold standard) and specificity (number of cases negative in both tests / number of cases negative in gold standard) is calculated.


Current Secondary Outcome: The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment [ Time Frame: six weeks after praziquantel treatment ]

Original Secondary Outcome: Same as current

Information By: Leiden University Medical Center

Dates:
Date Received: July 15, 2014
Date Started: January 2015
Date Completion:
Last Updated: March 13, 2017
Last Verified: March 2017