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

Learn more about:
Related Clinical Trial
Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires Prevalence of Chronic Kidney Disease (CKD) and Risk Factors in Sub-Saharan Africa S. Japonicum and Pregnancy Outcomes Artemisinin-based Combination Therapy-Intermittent Preventive Treatment (ACT-IPT) Trial Among Schoolchildren in Kassena-Nankana, Ghana Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions L-praziquantel Orodispersible Tablets (L-PZQ ODT) in Schistosoma Infected Children The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda Praziquantel in Children Under Age 4 Schistosoma Haematobium Infections and Praziquantel Antioxidant Supplements in the Reversal of Schistosomal Peri-portal Fibrosis Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults Single-sex Female Controlled Human Schistosomiasis Mansoni Infection An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni) Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal Praziquantel-Pharmacokinetic Study Schistosomiasis in Women of Reproductive Age in Burkina Faso: Implications for Control Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia Schistosomiasis in Formal and Non-Formal Schools in Uganda: Implications for Control Programmes Using Community-Based Volunteers to Reach Non-Enrolled School Aged Children Through Community-Directed Treatment of Schistosomiasis in School-Aged Children in Rural Northern Ghana Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis A Phase I Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® With or Without GLA-AF for Intestinal Schistosomiasis in Healthy Adults Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study Schistosomiasis in Senegal Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST) Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis Arachidonic Acid Treatment Against Schistosomiasis Infection in Children Detection of Schistosomiasis CAA in Travellers After High-risk Water Contact Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis Health Benefits of Repeated Treatment in Pediatric Schistosomiasis Seropositivity and Adverse Birth Events in Migrants From Bilharzia-endemic Areas Women and Children as the Focus for Control of Schistosomiasis Infections in the Irrigations Area of Burkina Faso

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