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

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ClinicalTrials.gov Identifier: NCT02194712
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Meta Roestenberg, Leiden University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
Schistosomiasis Other: Urine CAA detection

Study Design
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Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Schistosomiasis Circulating Anodic Antigen (CAA) in Travellers After High-risk Water Contact
Actual Study Start Date : January 2015
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
travellers
travellers with recent (<12 weeks) high risk water contact are included in the study and asked to provide samples for CAA testing
 Other: Urine CAA detection
In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


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

Biospecimen Retention:   Samples With DNA
serum, urine and faeces

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Travellers with reported high-risk water contact <12 weeks before inclusion.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194712


Locations
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Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1100 DD
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Harbour Hospital
Rotterdam, Netherlands, 3011 TG
Sponsors and Collaborators
Meta Roestenberg
Investigators
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Principal Investigator: M.P. Grobusch, Prof. MD. PhD VU University Medical Center
Principal Investigator: P.J.J. van Genderen, MD, PhD Harbour Hospital Rotterdam
Principal Investigator: M. Roestenberg, MD. PhD. Leiden University Medical Center
More Information
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Publications of Results:

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Responsible Party: Meta Roestenberg, M.Roestenberg, MD PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02194712    
Other Study ID Numbers: CAA48780
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Keywords provided by Meta Roestenberg, Leiden University Medical Center:
circulating anodic antigen
Additional relevant MeSH terms:
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Schistosomiasis
Trematode Infections
Helminthiasis
Parasitic Diseases