Clinical trial NCT02194712: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schistosomiasis
Keywords: circulating anodic antigen
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Travellers with reported high-risk water contact \<12 weeks before inclusion.

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.


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

Primary outcomes:
measure: The sensitivity and specificity of UCP-CAA
timeFrame: 12 weeks after last water contact
Secondary outcomes:
measure: The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment
timeFrame: six weeks after praziquantel treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: Harbour Hospital
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: M.P. Grobusch, Prof. MD. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harbour Hospital Rotterdam
name: P.J.J. van Genderen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Center
name: M. Roestenberg, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 infection in travellers: a prospective study. J Travel Med. 2020 Jul 14;27(4):taaa055. doi: 10.1093/jtm/taaa055.