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

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Brief Title

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

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.

Study Type

Observational

Primary Outcome

The sensitivity and specificity of UCP-CAA

Secondary Outcome

 The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment

Condition

Schistosomiasis

Intervention

Urine CAA detection

Study Arms / Comparison Groups

 travellers
Description:  travellers with recent (<12 weeks) high risk water contact are included in the study and asked to provide samples for CAA testing

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

106

Start Date

January 2015

Completion Date

September 2019

Primary Completion Date

September 2019

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

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

M.P. Grobusch, Prof. MD. PhD, ,

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT02194712

Organization ID

CAA48780

Responsible Party

Sponsor-Investigator

Study Sponsor

Meta Roestenberg

Study Sponsor

M.P. Grobusch, Prof. MD. PhD, Principal Investigator, VU University Medical Center

Verification Date

February 2020