Primary objective: to assess the UCP-LF CAA test in travellers with high-risk water contact as compared to routine diagnostics
ID
Source
Brief title
Condition
- Helminthic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
The sensitivity and specificity of urine UCP-CAA in travellers with reported
high-risk water contact, as compared with routine diagnostics.
Secondary outcome
Secondary endpoint:
The percentage of travellers with persisting positive urine UCP-LF CAA six
weeks after conventional praziquantel treatment
Background 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 LUMC has developed a novel diagnostic test to
detect circulating anodic antigen (CAA) with the up-converting phosphor lateral
flow (UCP-LF) technique, that 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 the UCP-LF CAA assay in
urine of travellers with high-risk water contact.
Study objective
Primary objective: to assess the UCP-LF CAA test in travellers with high-risk
water contact as compared to routine diagnostics
Study design
Open label, prospective, observational study
Study burden and risks
Travellers with reported high-risk water contact are requested to participate
in the study. The attending physician records data on their health and travel
history and ask their consent to donate blood, urine and faeces in addition to
routine diagnostic procedures (max 3 occasions). No more than 60 mL blood will
be drawn in total. Risks associated with participating in the study are related
to a maximum of three venapunctures in addition to routine diagnostics.
Participants do not benefit directly from their participation, as there is no
interventions; study participation will be altruistic. However, a summary of
study results will be sent out to all study participants if requested on
recruitment.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
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 2 years 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 before last high risk water contact
3. The use of immunosuppressive or immunomodulatory drugs at presentation that compromise the interpretation of schistosomiasis serology
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02194712 |
| CCMO | NL48780.058.14 |