Schistosoma HaematobiumSchistoBreak-DNCT06808750
Performance of Tests for Schistosoma Haematobium Diagnosis
An observational study of Schistosoma Haematobium, run by Stefanie Knopp at 1 site in Tanzania.
Trial summary
Urogenital schistosomiasis caused by infection with the blood fluke Schistosoma haematobium is a debilitating disease. The World Health Organization (WHO) has set the goal to eliminate schistosomiasis as a public health problem globally by 2030 and to interrupt transmission in selected areas. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosoma Haematobium
- What is being tested?
- S. haematobium egg detection by single urine filtration, S. haematobium egg detection by quintuple urine filtration and S. haematobium egg detection by artificial intelligence (AI) microscopy
- How many people
- 801 participants
- Where
- 1 siteTanzania
- Study dates
- 10 Feb 2025to 30 Apr 2025
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children from Pemba Island, United Republic of Tanzania, that attend one among the two pre-selected study primary schools in grade 3, 4, 5 or 6.
Who may be able to join
- Subjects fulfilling all of the following inclusion criteria are eligible for the initial screening:
- Attendance of grade 3, 4, 5, or 6 in study school
- Randomized to participate in initial screening
- Written informed consent signed by the parents
- Written assent signed by the participant if aged12-17 years old
- Subjects fulfilling all of the following inclusion criteria are eligible for the diagnostic study:
Show all 12Show fewer
- Attendance of grade 3, 4, 5, or 6 in study school
- Randomized to participate in initial screening
- Written informed consent signed by the parents
- Written assent signed by the participant if aged12-17 years old
- S. haematobium-positive urine filtration result in initial screening OR
- S. haematobium-negative urine filtration result in initial screening, but randomized for participation in diagnostic study
Who cannot join
- The presence of any one of the following exclusion criteria will lead to the exclusion of the subject in the initial screening:
- Not attending any study school
- Not attending grade 3, 4, 5 or 6
- Not randomized to participate in initial screening
- No written informed consent signed by the parents submitted
- No written assent signed by the participant if aged12-17 years old submitted
Show all 16Show fewer
- S. haematobium-negative urine filtration result in initial screening, and not randomized for participation in diagnostic performance study
- Clinical significant sever disease
- The presence of any one of the following exclusion criteria will lead to the exclusion of the subject in the diagnostic study:
- Not attending any study school
- Not attending grade 3, 4, 5 or 6
- Not randomized to participate in initial screening
- No written informed consent signed by the parents submitted
- No written assent signed by the participant if aged12-17 years old submitted
- S. haematobium-negative urine filtration result in initial screening, and not randomized for participation in diagnostic performance study
- Clinical significant sever disease
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Public Health Laboratory - Ivo de Carneri (PHL-IdC)
Chake Chake, Pemba Island
About this study
Official title: Schistosoma Haematobium Diagnostic Test Performance in the Elimination Setting Pemba, Tanzania
Urogenital schistosomiasis caused by infection with the blood fluke Schistosoma haematobium is a debilitating disease. The World Health Organization (WHO) has set the goal to eliminate schistosomiasis as a public health problem globally by 2030 and to interrupt transmission in selected areas. Many years of control interventions and mass drug administration have reduced substantially the prevalence and infection intensities in several areas. In areas with an infection prevalence <10%, the WHO suggests to continue population preventive chemotherapy with praziquantel at the same or reduced frequency, or to use a clinical approach of test-and-treat. In areas that have achieved interruption of transmission, elimination needs to be validated and post-elimination surveillance be implemented.
For determination of infection prevalence thresholds, for test-and-treat, for validation of elimination and for pre- and post-elimination surveillance, reliable diagnostic tools are needed.
Read more
In a single-centre study conducted in Pemba, United Republic of Tanzania, the investigators aim to assess the accuracy and performance of standard and new diagnostic tests for S. haematobium diagnosis for use in elimination settings.
The primary objective of the study is to assess the sensitivity and specificity of all investigated diagnostic tests, using the S. haematobium egg count results of five urine filtrations conducted on five urine samples collected over five consecutive days as reference test.
Secondary objectives are:
- To assess the sensitivity and specificity of all investigated diagnostic tests, using latent class analyses.
- To assess the sensitivity and specificity of all investigated diagnostic tests, in relation to S. haematobium infection intensity, calculated as mean egg count derived from the egg counts in five urine samples collected over 5 consecutive days.
- To assess the sensitivity and specificity of all investigated diagnostic tests, in relation to S. haematobium infection intensity, calculated from the egg counts of the urine sample that was analysed with the respective test and urine filtration.
- To assess the sensitivity and specificity of all investigated diagnostic tests, using the results of the up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA) as reference test.
- To assess the sensitivity and specificity of all investigated molecular diagnostic tests, using the results of the qPCR as reference test.
- To assess the cost and time needed for the implementation of single or multiple-throughput tests.
Our study will evaluate the accuracy and performance of diagnostic tests, in a formerly highly endemic setting that is now approaching elimination (Pemba), and will hence provide important information about which tests can be recommended for threshold determination, and test-and-treat and surveillance.
- Conditions
- Schistosoma Haematobium
- Being tested
- S. haematobium egg detection by single urine filtration, S. haematobium egg detection by quintuple urine filtration, S. haematobium egg detection by artificial intelligence (AI) microscopy, Haematuria assessment using reagent strips, S. haematobium antigen detection by up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA)
- Keywords
- schistosomiasis, diagnosis, elimination, control
- Medical subject headings
- Schistosomiasis haematobia, Schistosomiasis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S. haematobium egg detection by single urine filtrationDiagnostic test
The urine samples of children participating in the initial screening will be tested with a single urine filtration by human microscopy.
S. haematobium egg detection by quintuple urine filtrationDiagnostic test
Five urine samples will be collected from children participating in the diagnostic study over five days. Each of the five urine samples collected per participant will be tested with a single urine filtration by human microscopy.
S. haematobium egg detection by artificial intelligence (AI) microscopyDiagnostic test
The urine samples collected on Day 5 of the diagnostic study will be tested with artificial intelligence (AI) microscopy.
Haematuria assessment using reagent stripsDiagnostic test
The urine samples collected from children participating in the initial screening and in the diagnostic study, respectively, will be tested with reagent strips.
S. haematobium antigen detection by up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA)Diagnostic test
The urine samples collected on Day 5 of the diagnostic study will be tested with the up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA).
S. haematobium DNA detection by recombinase polymerase amplification assay (RPA)Diagnostic test
The urine samples collected on Day 5 of the diagnostic study will be tested with the recombinase polymerase amplification assay (RPA).
S. haematobium DNA detection by qPCRDiagnostic test
The urine samples collected on Day 5 of the diagnostic study will be tested with qPCR
| Study group | Role | What they receive |
|---|---|---|
| Participants of initial screening | Schoolchildren that attend classes in grades 3-6 in each of the two study schools will be invited to submit one urine sample that will be tested with a single urine filtration (Day 1). Receives: Diagnostic Test: S. haematobium egg detection by single urine filtration; Diagnostic Test: Haematuria assessment using reagent strips | |
| Participants of diagnostic study | All schoolchildren that are tested S. haematobium-positive children in the initial screening plus a sex-adjusted random selection of initially negative-screened children will be included in the diagnostic study. These children will be invited to submit five urine samples in total, over five days (Day 1-5). All samples (Day 1-5) will be tested with a single urine filtration. Samples collected on Day 5 will be tested with all investigated diagnostic tests. Receives: Diagnostic Test: S. haematobium egg detection by single urine filtration; Diagnostic Test: S. haematobium egg detection by quintuple urine filtration; Diagnostic Test: S. haematobium egg detection by artificial intelligence (AI) microscopy; Diagnostic Test: Haematuria assessment using reagent strips; Diagnostic Test: S. haematobium antigen detection by up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA); Diagnostic Test: S. haematobium DNA detection by recombinase polymerase amplification assay (RPA); Diagnostic Test: S. haematobium DNA detection by qPCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of tests for S. haematobium diagnosis when compared with a single urine filtration
The primary endpoint will be the sensitivity of the investigated diagnostic tests to detect S. haematobium related markers by the examination of a single sample.
The primary outcome variable will be the number of S. haematobium infected individuals detected through each test.
Measured: From enrollment to the end of the study after 6 weeks
Secondary outcomes (1)
Sensitivity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
Sensitivity is defined as the proportion of positive test results out of all truly positive samples. Reference tests are human microscopy, UCP-CAA, qPCR or a combination thereof, performed with the same urine sample (human microscopy, UCP-CAA, qPCR) or quintuple urine samples (human microscopy).
Measured: From enrollment to the end of the study after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start10 Feb 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Schistosoma HaematobiumStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefanie Knopp
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri, Enaiblers AB, Erasmus Medical Center, Leiden University Medical Center, Natural History Museum, United Kingdom
- Responsible party
- Sponsor-investigator, Stefanie Knopp, Swiss Tropical & Public Health Institute
- Investigators
- Stefanie Knopp, PhD, Principal investigator, Swiss Tropical & Public Health InstituteSaid M Ali, MSc, Study director, Public Health Laboratory Ivo de Carneri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808750
- Sponsor's protocol ID
- 1687
- Other IDs
- PR00P3_179753
- Acronym
- SchistoBreak-D
- Status last verified
- Sep 2025
- First submitted
- 8 Jan 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * There are data transfer agreements (DTAs) in place between the Public Health Laboratory-Ivo de Carneri (PHL-IdC) in Pemba and the Swiss Tropical and Public Health Institute (Swiss TPH), Switzerland; Leiden University Medical Centre (LUMC), The Netherlands; Natural History Museum (NHM), London, UK; and Enaiblers, Sweden. * Anonymized data will be curated and stored for an unlimited period in the data repository "Infectious Diseases Data Observatory" (IDDO; https://www.iddo.org/) and/or Zenodo (https://zenodo.org/). * Data may be shared with other researchers upon request.
Publications
Ndum NC, Ali SM, Ali MN, Bergelin J, Hattendorf J, Hoekstra PT, van Lieshout L, Pennance T, Suleiman KR, Utzinger J, Ward P, Webster BL, Knopp S. Evaluation of six different tests for Schistosoma haematobium diagnosis in a near-elimination setting: A prospective observational diagnostic accuracy study. PLoS Negl Trop Dis. 2026 Sep 15;20(9):e0014066. doi: 10.1371/journal.pntd.0014066. eCollection 2026 Sep.
PubMed 42743322Ndum NC, Ali SM, Ali MN, Hattendorf J, Suleiman KR, Utzinger J, Knopp S. Day-to-day variation of Schistosoma haematobium infection and intensity estimates in the near-elimination setting Pemba, Tanzania. Acta Trop. 2026 Aug;280:108177. doi: 10.1016/j.actatropica.2026.108177. Epub 2026 Jun 7.
PubMed 42259467
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schistosoma Haematobium Diagnostic Test Performance in the Elimination Setting Pemba, Tanzania
- ClinicalTrials.gov ID
- NCT06808750
- Acronym / sponsor ID
- SchistoBreak-D / 1687
- Conditions
- Schistosoma Haematobium
- Keywords
- schistosomiasis, diagnosis, elimination, control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- Stefanie KnoppUniversity, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri, Enaiblers AB, Erasmus Medical Center, Leiden University Medical Center, Natural History Museum, United Kingdom
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Feb 2025 (actual)
- 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.
Urogenital schistosomiasis caused by infection with the blood fluke Schistosoma haematobium is a debilitating disease. The World Health Organization (WHO) has set the goal to eliminate schistosomiasis as a public health problem globally by 2030 and to interrupt transmission in selected areas. Many years of control interventions and mass drug administration have reduced substantially the prevalence and infection intensities in several areas. In areas with an infection prevalence <10%, the WHO suggests to continue population preventive chemotherapy with praziquantel at the same or reduced frequency, or to use a clinical approach of test-and-treat. In areas that have achieved interruption of transmission, elimination needs to be validated and post-elimination surveillance be implemented.
For determination of infection prevalence thresholds, for test-and-treat, for validation of elimination and for pre- and post-elimination surveillance, reliable diagnostic tools are needed.
In a single-centre study conducted in Pemba, United Republic of Tanzania, the investigators aim to assess the accuracy and performance of standard and new diagnostic tests for S. haematobium diagnosis for use in elimination settings.
The primary objective of the study is to assess the sensitivity and specificity of all investigated diagnostic tests, using the S. haematobium egg count results of five urine filtrations conducted on five urine samples collected over five consecutive days as reference test.
Secondary objectives are:
- To assess the sensitivity and specificity of all investigated diagnostic tests, using latent class analyses.
- To assess the sensitivity and specificity of all investigated diagnostic tests, in relation to S. haematobium infection intensity, calculated as mean egg count derived from the egg counts in five urine samples collected over 5 consecutive days.
- To assess the sensitivity and specificity of all investigated diagnostic tests, in relation to S. haematobium infection intensity, calculated from the egg counts of the urine sample that was analysed with the respective test and urine filtration.
- To assess the sensitivity and specificity of all investigated diagnostic tests, using the results of the up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA) as reference test.
- To assess the sensitivity and specificity of all investigated molecular diagnostic tests, using the results of the qPCR as reference test.
- To assess the cost and time needed for the implementation of single or multiple-throughput tests.
Our study will evaluate the accuracy and performance of diagnostic tests, in a formerly highly endemic setting that is now approaching elimination (Pemba), and will hence provide important information about which tests can be recommended for threshold determination, and test-and-treat and surveillance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants of initial screening | – | Diagnostic Test: S. haematobium egg detection by single urine filtration, Diagnostic Test: Haematuria assessment using reagent stripsSchoolchildren that attend classes in grades 3-6 in each of the two study schools will be invited to submit one urine sample that will be tested with a single urine filtration (Day 1). |
| Participants of diagnostic study | – | Diagnostic Test: S. haematobium egg detection by single urine filtration, Diagnostic Test: S. haematobium egg detection by quintuple urine filtration, Diagnostic Test: S. haematobium egg detection by artificial intelligence (AI) microscopy, Diagnostic Test: Haematuria assessment using reagent strips, Diagnostic Test: S. haematobium antigen detection by up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA), Diagnostic Test: S. haematobium DNA detection by recombinase polymerase amplification assay (RPA), Diagnostic Test: S. haematobium DNA detection by qPCRAll schoolchildren that are tested S. haematobium-positive children in the initial screening plus a sex-adjusted random selection of initially negative-screened children will be included in the diagnostic study. These children will be invited to submit five urine samples in total, over five days (Day 1-5). All samples (Day 1-5) will be tested with a single urine filtration. Samples collected on Day 5 will be tested with all investigated diagnostic tests. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children from Pemba Island, United Republic of Tanzania, that attend one among the two pre-selected study primary schools in grade 3, 4, 5 or 6.
Key inclusion criteria (12 listed)
- Subjects fulfilling all of the following inclusion criteria are eligible for the initial screening:
- Attendance of grade 3, 4, 5, or 6 in study school
- Randomized to participate in initial screening
- Written informed consent signed by the parents
- Written assent signed by the participant if aged12-17 years old
Key exclusion criteria (16 listed)
- The presence of any one of the following exclusion criteria will lead to the exclusion of the subject in the initial screening:
- Not attending any study school
- Not attending grade 3, 4, 5 or 6
- Not randomized to participate in initial screening
- No written informed consent signed by the parents submitted
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 |
|---|---|---|
| S. haematobium egg detection by single urine filtrationThe urine samples of children participating in the initial screening will be tested with a single urine filtration by human microscopy. | Diagnostic test | Participants of diagnostic study, Participants of initial screening |
| S. haematobium egg detection by quintuple urine filtrationFive urine samples will be collected from children participating in the diagnostic study over five days. Each of the five urine samples collected per participant will be tested with a single urine filtration by human microscopy. | Diagnostic test | Participants of diagnostic study |
| S. haematobium egg detection by artificial intelligence (AI) microscopyThe urine samples collected on Day 5 of the diagnostic study will be tested with artificial intelligence (AI) microscopy. | Diagnostic test | Participants of diagnostic study |
| Haematuria assessment using reagent stripsThe urine samples collected from children participating in the initial screening and in the diagnostic study, respectively, will be tested with reagent strips. | Diagnostic test | Participants of diagnostic study, Participants of initial screening |
| S. haematobium antigen detection by up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA)The urine samples collected on Day 5 of the diagnostic study will be tested with the up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA). | Diagnostic test | Participants of diagnostic study |
| S. haematobium DNA detection by recombinase polymerase amplification assay (RPA)The urine samples collected on Day 5 of the diagnostic study will be tested with the recombinase polymerase amplification assay (RPA). | Diagnostic test | Participants of diagnostic study |
| S. haematobium DNA detection by qPCRThe urine samples collected on Day 5 of the diagnostic study will be tested with qPCR | Diagnostic test | Participants of diagnostic study |
Primary outcome
Accuracy of tests for S. haematobium diagnosis when compared with a single urine filtration
Time frame: From enrollment to the end of the study after 6 weeks
The primary endpoint will be the sensitivity of the investigated diagnostic tests to detect S. haematobium related markers by the examination of a single sample. The primary outcome variable will be the number of S. haematobium infected individuals detected through each test.
1 secondary outcome
Sensitivity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
Time frame: From enrollment to the end of the study after 6 weeks
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 19 Sep 2025.
- Derived from this study: PubMed 42743322Ndum NC, Ali SM, Ali MN, Bergelin J, Hattendorf J, Hoekstra PT, van Lieshout L, Pennance T, Suleiman KR, Utzinger J, Ward P, Webster BL, Knopp S. Evaluation of six different tests for Schistosoma haematobium diagnosis in a near-elimination setting: A prospective observational diagnostic accuracy study. PLoS Negl Trop Dis. 2026 Sep 15;20(9):e0014066. doi: 10.1371/journal.pntd.0014066. eCollection 2026 Sep.
- Derived from this study: PubMed 42259467Ndum NC, Ali SM, Ali MN, Hattendorf J, Suleiman KR, Utzinger J, Knopp S. Day-to-day variation of Schistosoma haematobium infection and intensity estimates in the near-elimination setting Pemba, Tanzania. Acta Trop. 2026 Aug;280:108177. doi: 10.1016/j.actatropica.2026.108177. Epub 2026 Jun 7.
- Individual participant dataSharing planned: Yes. * There are data transfer agreements (DTAs) in place between the Public Health Laboratory-Ivo de Carneri (PHL-IdC) in Pemba and the Swiss Tropical and Public Health Institute (Swiss TPH), Switzerland; Leiden University Medical Centre (LUMC), The Netherlands; Natural History Museum (NHM), London, UK; and Enaiblers, Sweden. * Anonymized data will be curated and stored for an unlimited period in the data repository "Infectious Diseases Data Observatory" (IDDO; https://www.iddo.org/) and/or Zenodo (https://zenodo.org/). * Data may be shared with other researchers upon request.
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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.
Stefanie Knopp, PhD principal investigator
Swiss Tropical & Public Health Institute
Said M Ali, MSc study director
Public Health Laboratory Ivo de Carneri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schistosoma Haematobium, run by Stefanie Knopp at 1 site in Tanzania.
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 12 inclusion and 16 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. 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?
Accuracy of tests for S. haematobium diagnosis when compared with a single urine filtration (time frame: From enrollment to the end of the study after 6 weeks). 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 NCT06808750, which also lists 2 linked publications.
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 19 Sep 2025.