- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02194712
Detection of Schistosomiasis CAA in Travellers After High-risk Water Contact
November 16, 2020 updated by: Meta Roestenberg
Detection of Schistosomiasis Circulating Anodic Antigen (CAA) in Travellers After High-risk Water Contact
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 Overview
Study Type
Observational
Enrollment (Actual)
106
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amsterdam, Netherlands, 1100 DD
- Academic Medical Center
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Leiden, Netherlands, 2333 ZA
- Leiden University Medical Center
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Rotterdam, Netherlands, 3011 TG
- Harbour Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Travellers with reported high-risk water contact <12 weeks before inclusion.
Description
Inclusion Criteria:
- 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
- Agreement to perform routine diagnostic procedures to diagnose schistosomiasis infection
- Willing to provide a maximum of three additional blood samples in addition to routine diagnostic procedures
- Able to provide informed consent
Exclusion Criteria:
- Previous treatment for schistosomiasis
- Known positive schistosomiasis serology
- The use of immunosuppressive or immunomodulatory drugs at presentation that compromise the interpretation of schistosomiasis serology
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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travellers
travellers with recent (<12 weeks) high risk water contact are included in the study and asked to provide samples for CAA testing
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In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The sensitivity and specificity of UCP-CAA
Time Frame: 12 weeks after last water contact
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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.
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12 weeks after last water contact
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment
Time Frame: six weeks after praziquantel treatment
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six weeks after praziquantel treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: M.P. Grobusch, Prof. MD. PhD, Amsterdam UMC, location VUmc
- Principal Investigator: P.J.J. van Genderen, MD, PhD, Harbour Hospital Rotterdam
- Principal Investigator: M. Roestenberg, MD. PhD., Leiden University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2015
Primary Completion (ACTUAL)
September 1, 2019
Study Completion (ACTUAL)
September 1, 2019
Study Registration Dates
First Submitted
July 15, 2014
First Submitted That Met QC Criteria
July 16, 2014
First Posted (ESTIMATE)
July 18, 2014
Study Record Updates
Last Update Posted (ACTUAL)
November 18, 2020
Last Update Submitted That Met QC Criteria
November 16, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAA48780
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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