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

NCT02194712 | Completed

• 1 other identifier: CAA48780
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 3

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.

Conditions

Schistosomiasis

Keywords

circulating anodic antigen

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of UCP-CAA

  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.

  12 weeks after last water contact

Secondary Outcomes (1)

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

  six weeks after praziquantel treatment

Study Arms (1)

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

Interventions

Urine CAA detection OTHER

In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.

travellers

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Travellers with reported high-risk water contact \<12 weeks before inclusion.

You may qualify if:

• 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

You may not qualify if:

• Previous treatment for schistosomiasis
• Known positive schistosomiasis serology
• The use of immunosuppressive or immunomodulatory drugs at presentation that compromise the interpretation of schistosomiasis serology

Sponsors & Collaborators

• Meta Roestenberg: lead

Study Sites (3)

Academic Medical Center

Amsterdam, 1100 DD, Netherlands

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Harbour Hospital

Rotterdam, 3011 TG, Netherlands

Location

Related Publications (1)

• Casacuberta-Partal M, Janse JJ, van Schuijlenburg R, de Vries JJC, Erkens MAA, Suijk K, van Aalst M, Maas JJ, Grobusch MP, van Genderen PJJ, de Dood C, Corstjens PLAM, van Dam GJ, van Lieshout L, Roestenberg M. Antigen-based diagnosis of Schistosoma infection in travellers: a prospective study. J Travel Med. 2020 Jul 14;27(4):taaa055. doi: 10.1093/jtm/taaa055.

  PMID: 32307517 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

serum, urine and faeces

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.Roestenberg, MD PhD

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 18, 2014
• Study Start: January 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: November 18, 2020

Record last verified: 2020-11

Locations

NL (3)