Aged ≥2 Years in Schistosomiasis Affected AreasSchisCCANCT03870204
Validation of POC-CCA Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
An observational study of Aged ≥2 Years in Schistosomiasis Affected Areas, run by Ina-Respond at 1 site in Indonesia.
Trial summary
This is a longitudinal cohort study that will be coordinated with the 2019 schistosomiasis stool survey in Napu. The study will use the stool survey results as entry criteria to identify subjects to become the index cases. Contact investigation will be conducted to the index cases during home visit (Visit 1). Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged ≥2 Years in Schistosomiasis Affected Areas
- What is being tested?
- POC-CCA rapid urine test
- How many people
- 186 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Sep 2019to 2 Jul 2020
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Schistosomiasis affected areas are in Lindu, Napu and Bada Valley of Central Sulawesi, Indonesia.
Who may be able to join
- Reside in schistosomiasis affected areas for at least 8 weeks.
- Age ≥2 years.
- Provides a documented informed consent for participants' ≥18 years old or informed consent by parents/legally accepted representative (LAR) or assent for minor participants prior to the study procedures.
- Willing to comply with the study procedures.
- Agrees to the collection and storage of specimens.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Donggala Research and Development (R&D) Center, Ministry of Health of Indonesia
Donggala, Central of Sulawesi, 94353
About this study
Official title: Validation of the Schistosomiasis Point-of-Care Circulating Cathodic Antigen (POC-CCA) Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
This is a longitudinal cohort study that will be coordinated with the 2019 schistosomiasis stool survey in Napu. The study will use the stool survey results as entry criteria to identify subjects to become the index cases. Contact investigation will be conducted to the index cases during home visit (Visit 1). The index cases and their contacts meeting the study's eligibility criteria will be recruited. For Visit 1, they will be tested for schistosomiasis by on the spot POC-CCA, stool samples will be tested for KK at Donggala R\&D Center Laboratory and urinary tract infection (UTI) by urine dipsticks, stool samples will be tested for schistosomiasis and soil transmitted helminths (STH) by KK at Donggala R\&D Center Laboratory and by molecular assay (Taqman qPCR) at the INA-RESPOND Reference Laboratory, while dried blood spots samples will be tested for schistosome antibodies by ELISA at the INA-RESPOND Reference Laboratory. The study KK and/or POC-CCA will be used to determine their schistosomiasis status. Those with positive schistosomiasis status by KK and/or POC-CCA will continue follow up to Visit 2 and 3.
Read the detailed description
Indonesia's plan for elimination of schistosomiasis by 2025 requires a better understanding of the factors associated with infection, effective epidemiologic monitoring, and optimization of diagnostic and treatment strategies. In settings of low prevalence such as Lindu, Napu and Bada regions of Central Sulawesi, an ultrasensitive technique to diagnose Schistosoma japonicum is needed. A diagnostic test that is efficient, accurate and easy to use would facilitate collection of reliable epidemiologic information and provide and effective means of assessing the impact of mass drug administration (MDA).
Primary Objective:
To estimate the accuracy of the schistosomiasis point-of-care circulating cathodic antigen (POC CCA) urine test for monitoring S. japonicum infection.
Secondary Objective
- To assess rates of positive testing by POC-CCA rapid urine test, serology, and molecular methods (PCR).
- To evaluate the impact of abnormal urinary findings, i.e. hematuria and markers of urinary tract infections (UTI), to POC-CCA rapid urine test results.
- To evaluate the efficacy of praziquantel administered by local primary health centers (Puskesmas).
- To assess number of schistosome infection using serology and molecular (PCR) as additional tests to disambiguate discordant results between KK and POC-CCA.
- To assess risk factors related to human schistosome infections.
- To estimate the proportion of soil transmitted helminths infection (STH), i.e. roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and hookworms (Necator americanus and Ancylostoma duodenale) in this population.
- To assess the association between color intensity of the POC-CCA rapid urine test band and the schistosome eggs per gram (EPG) of stool.
- To assess antibody response to schistosome infection. The number in the positive KK group will be 40 subjects, with the lowest estimated number is 25 subjects. Additional positive KK based on the re-testing KK results are expected and should increase the size for the positives. For the negatives, we calculated that a ratio of 4:1 negative to positive will be the best fit, thus 160 negative KK subjects will be enrolled. Additional 20% buffer to the negatives (32 negative KK subjects) will also be needed to estimate the specificity of POC-CCA with acceptable 95% CI. In total, we will enroll between 217 to 232 subjects in this study. The study will enroll all positive cases detected by the 2019 stool survey in Napu until the minimum sample size needed is met or until the data collection period has ended.
- Being tested
- POC-CCA rapid urine test
- Keywords
- Schistosoma japonicum
- Medical subject headings
- Schistosomiasis japonica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC-CCA rapid urine testDiagnostic test
Also called Kato-Katz, ELISA, and PCR
Fresh urine samples will be tested by POC-CCA
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the accuracy of the schistosomiasis point-of-care circulating cathodic antigen (POC CCA) urine test for monitoring Schistosoma japonicum infection
- Sensitivity will be established as the proportion of positives that are correctly identified by the POC-CCA rapid urine test, when compared to the Reference Method.
- Specificity will be established as the proportion of negatives that are correctly identified by the POC-CCA rapid urine test, when compared to the Reference Method.
Measured: 1 year
Secondary outcomes (8)
To assess rates of positive testing by POC-CCA rapid urine test, serology, and molecular methods (PCR).
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the POC-CCA rapid urine test.
Measured: 1 year
To evaluate the impact of abnormal urinary findings, i.e. hematuria and markers of urinary tract infections (UTI), to POC-CCA rapid urine test results.
Sensitivity and specificity of the POC-CCA rapid urine test, when compared to the Reference Method, among individuals with abnormal urinary findings.
Measured: 1 year
To evaluate the efficacy of praziquantel administered by local primary health centers (Puskesmas).
Evaluation of cure rate (percentage negative) after praziquantel administration to positive cases by either POC-CCA rapid urine test and/or KK.
Measured: 1 year
To assess number of schistosome infection using serology and molecular (PCR) as additional tests to disambiguate discordant results between KK and POC-CCA.
Number of schistosome infection using serology and molecular as additional examination to disambiguate discordant findings between KK and POC-CCA.
Measured: 1 year
To assess risk factors related to human schistosome infections.
Risk factors will be determined by estimating the odds ratio for each potential risk factor against the Reference Method results.
Measured: 1 year
To estimate the proportion of soil transmitted helminths infection (STH), i.e. roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and hookworms (Necator americanus and Ancylostoma duodenale) in this population.
Proportion of soil transmitted helminth infections
Measured: 1 year
To assess the association between color intensity of the POC-CCA rapid urine test band and the schistosome eggs per gram (EPG) of stool.
Association between the color intensity of the POC-CCA rapid urine test and the schistosome EPGs of stool.
Measured: 1 year
To assess antibody response to schistosome infection.
Antibody response to schistosome infection.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start4 Sep 2019
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aged ≥2 Years in Schistosomiasis Affected AreasStudies 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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ina-Respond
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Muhammad Karyana, dr. MKes, Principal investigator, Ina-Respond
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870204
- Sponsor's protocol ID
- INA105
- Other IDs
- U1111-1263-2399
- Acronym
- SchisCCA
- Status last verified
- Oct 2021
- First submitted
- 8 Mar 2019
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently we not have any plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Schistosomiasis Point-of-Care Circulating Cathodic Antigen (POC-CCA) Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
- ClinicalTrials.gov ID
- NCT03870204
- Acronym / sponsor ID
- SchisCCA / INA105
- Keywords
- Schistosoma japonicum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Ina-RespondUniversity, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 12 Mar 2019 (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.
This is a longitudinal cohort study that will be coordinated with the 2019 schistosomiasis stool survey in Napu. The study will use the stool survey results as entry criteria to identify subjects to become the index cases. Contact investigation will be conducted to the index cases during home visit (Visit 1). The index cases and their contacts meeting the study's eligibility criteria will be recruited. For Visit 1, they will be tested for schistosomiasis by on the spot POC-CCA, stool samples will be tested for KK at Donggala R\&D Center Laboratory and urinary tract infection (UTI) by urine dipsticks, stool samples will be tested for schistosomiasis and soil transmitted helminths (STH) by KK at Donggala R\&D Center Laboratory and by molecular assay (Taqman qPCR) at the INA-RESPOND Reference Laboratory, while dried blood spots samples will be tested for schistosome antibodies by ELISA at the INA-RESPOND Reference Laboratory. The study KK and/or POC-CCA will be used to determine their schistosomiasis status. Those with positive schistosomiasis status by KK and/or POC-CCA will continue follow up to Visit 2 and 3.
Detailed description
Indonesia's plan for elimination of schistosomiasis by 2025 requires a better understanding of the factors associated with infection, effective epidemiologic monitoring, and optimization of diagnostic and treatment strategies. In settings of low prevalence such as Lindu, Napu and Bada regions of Central Sulawesi, an ultrasensitive technique to diagnose Schistosoma japonicum is needed. A diagnostic test that is efficient, accurate and easy to use would facilitate collection of reliable epidemiologic information and provide and effective means of assessing the impact of mass drug administration (MDA).
Primary Objective:
To estimate the accuracy of the schistosomiasis point-of-care circulating cathodic antigen (POC CCA) urine test for monitoring S. japonicum infection.
Secondary Objective
- To assess rates of positive testing by POC-CCA rapid urine test, serology, and molecular methods (PCR).
- To evaluate the impact of abnormal urinary findings, i.e. hematuria and markers of urinary tract infections (UTI), to POC-CCA rapid urine test results.
- To evaluate the efficacy of praziquantel administered by local primary health centers (Puskesmas).
- To assess number of schistosome infection using serology and molecular (PCR) as additional tests to disambiguate discordant results between KK and POC-CCA.
- To assess risk factors related to human schistosome infections.
- To estimate the proportion of soil transmitted helminths infection (STH), i.e. roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and hookworms (Necator americanus and Ancylostoma duodenale) in this population.
- To assess the association between color intensity of the POC-CCA rapid urine test band and the schistosome eggs per gram (EPG) of stool.
- To assess antibody response to schistosome infection. The number in the positive KK group will be 40 subjects, with the lowest estimated number is 25 subjects. Additional positive KK based on the re-testing KK results are expected and should increase the size for the positives. For the negatives, we calculated that a ratio of 4:1 negative to positive will be the best fit, thus 160 negative KK subjects will be enrolled. Additional 20% buffer to the negatives (32 negative KK subjects) will also be needed to estimate the specificity of POC-CCA with acceptable 95% CI. In total, we will enroll between 217 to 232 subjects in this study. The study will enroll all positive cases detected by the 2019 stool survey in Napu until the minimum sample size needed is met or until the data collection period has ended.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Schistosomiasis affected areas are in Lindu, Napu and Bada Valley of Central Sulawesi, Indonesia.
Key inclusion criteria (5 listed)
- Reside in schistosomiasis affected areas for at least 8 weeks.
- Age ≥2 years.
- Provides a documented informed consent for participants' ≥18 years old or informed consent by parents/legally accepted representative (LAR) or assent for minor participants prior to the study procedures.
- Willing to comply with the study procedures.
- Agrees to the collection and storage of specimens.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| POC-CCA rapid urine testAlso: Kato-Katz, ELISA, and PCRFresh urine samples will be tested by POC-CCA | Diagnostic test | – |
Primary outcome
To estimate the accuracy of the schistosomiasis point-of-care circulating cathodic antigen (POC CCA) urine test for monitoring Schistosoma japonicum infection
Time frame: 1 year
* Sensitivity will be established as the proportion of positives that are correctly identified by the POC-CCA rapid urine test, when compared to the Reference Method. * Specificity will be established as the proportion of negatives that are correctly identified by the POC-CCA rapid urine test, when compared to the Reference Method.
8 secondary outcomes
To assess rates of positive testing by POC-CCA rapid urine test, serology, and molecular methods (PCR).
Time frame: 1 year
To evaluate the impact of abnormal urinary findings, i.e. hematuria and markers of urinary tract infections (UTI), to POC-CCA rapid urine test results.
Time frame: 1 year
To evaluate the efficacy of praziquantel administered by local primary health centers (Puskesmas).
Time frame: 1 year
To assess number of schistosome infection using serology and molecular (PCR) as additional tests to disambiguate discordant results between KK and POC-CCA.
Time frame: 1 year
To assess risk factors related to human schistosome infections.
Time frame: 1 year
To estimate the proportion of soil transmitted helminths infection (STH), i.e. roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and hookworms (Necator americanus and Ancylostoma duodenale) in this population.
Time frame: 1 year
To assess the association between color intensity of the POC-CCA rapid urine test band and the schistosome eggs per gram (EPG) of stool.
Time frame: 1 year
To assess antibody response to schistosome infection.
Time frame: 1 year
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 2 Nov 2021.
- Individual participant dataSharing planned: No. Currently we not have any plan to share IPD.
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.
Muhammad Karyana, dr. MKes principal investigator
Ina-Respond
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 Aged ≥2 Years in Schistosomiasis Affected Areas, run by Ina-Respond at 1 site in Indonesia.
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 5 inclusion and 1 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 2 Nov 2021. 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 Indonesia. 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?
To estimate the accuracy of the schistosomiasis point-of-care circulating cathodic antigen (POC CCA) urine test for monitoring Schistosoma japonicum infection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2021.