SchistosomiasisNCT02194712
Detection of Schistosomiasis CAA in Travellers After High-risk Water Contact
An observational study of Schistosomiasis, run by Meta Roestenberg at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis
- What is being tested?
- Urine CAA detection
- How many people
- 106 participants
- Where
- 3 sitesNetherlands
- Study dates
- Jan 2015to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Travellers with reported high-risk water contact <12 weeks before inclusion.
Who may be able to join
- 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
Who cannot join
- Previous treatment for schistosomiasis
- Known positive schistosomiasis serology
- The use of immunosuppressive or immunomodulatory drugs at presentation that compromise the interpretation of schistosomiasis serology
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Academic Medical Center
Amsterdam, 1100 DD
Leiden University Medical Center
Leiden, 2333 ZA
Harbour Hospital
Rotterdam, 3011 TG
About this study
Official title: 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.
- Conditions
- Schistosomiasis
- Being tested
- Urine CAA detection
- Keywords
- circulating anodic antigen
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine CAA detectionOther
In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.
| Study group | Role | What they receive |
|---|---|---|
| travellers | travellers with recent (<12 weeks) high risk water contact are included in the study and asked to provide samples for CAA testing Receives: Other: Urine CAA detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after last water contact
Secondary outcomes (1)
The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment
Measured: six weeks after praziquantel treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meta Roestenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meta Roestenberg, Leiden University Medical Center
- Investigators
- M.P. Grobusch, Prof. MD. PhD, Principal investigator, Amsterdam UMC, location VUmcP.J.J. van Genderen, MD, PhD, Principal investigator, Harbour Hospital RotterdamM. Roestenberg, MD. PhD., Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194712
- Sponsor's protocol ID
- CAA48780
- Status last verified
- Nov 2020
- First submitted
- 15 Jul 2014
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32307517
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Schistosomiasis Circulating Anodic Antigen (CAA) in Travellers After High-risk Water Contact
- ClinicalTrials.gov ID
- NCT02194712
- Acronym / sponsor ID
- CAA48780
- Conditions
- Schistosomiasis
- Keywords
- circulating anodic antigen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Meta RoestenbergUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| travellers | – | Other: Urine CAA detectiontravellers with recent (<12 weeks) high risk water contact are included in the study and asked to provide samples for CAA testing |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Travellers with reported high-risk water contact <12 weeks before inclusion.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Previous treatment for schistosomiasis
- Known positive schistosomiasis serology
- The use of immunosuppressive or immunomodulatory drugs at presentation that compromise the interpretation of schistosomiasis serology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine CAA detectionIn addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination. | Other | travellers |
Primary outcome
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.
1 secondary outcome
The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment
Time frame: six weeks after praziquantel treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Results publication: PubMed 32307517Casacuberta-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.
Related trials for Schistosomiasis
Not yet recruitingPhase 3
A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital Schistosomiasis
Female Genital Schistosomiasis
Not yet recruitingPhase 2/3
Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis
Schistosomiasis, Schistosoma Mansoni
Not yet recruiting
Assessment of Right Ventricular-Pulmonary Arterial Coupling in Schistosomiasis-Associated Pulmonary Arterial Hypertension
Schistosomiasis
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
Onchocerciasis (River Blindness), Schistosomiasis
Not yet recruitingObservational study
Nanobody-based Schistosomiasis Urine Test Kit Research
Schistosomiasis Haematobia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M.P. Grobusch, Prof. MD. PhD principal investigator
Amsterdam UMC, location VUmc
P.J.J. van Genderen, MD, PhD principal investigator
Harbour Hospital Rotterdam
M. Roestenberg, MD. PhD. principal investigator
Leiden University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schistosomiasis, run by Meta Roestenberg at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of UCP-CAA (time frame: 12 weeks after last water contact). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02194712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.