- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03870204
Validation of POC-CCA Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum (SchisCCA)
Validation of the Schistosomiasis Point-of-Care Circulating Cathodic Antigen (POC-CCA) Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Central Of Sulawesi
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Donggala, Central Of Sulawesi, Indonesia, 94353
- Donggala Research and Development (R&D) Center, Ministry of Health of Indonesia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
None.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess rates of positive testing by POC-CCA rapid urine test, serology, and molecular methods (PCR).
Time Frame: 1 year
|
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the POC-CCA rapid urine test.
|
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
|
Sensitivity and specificity of the POC-CCA rapid urine test, when compared to the Reference Method, among individuals with abnormal urinary findings.
|
1 year
|
To evaluate the efficacy of praziquantel administered by local primary health centers (Puskesmas).
Time Frame: 1 year
|
Evaluation of cure rate (percentage negative) after praziquantel administration to positive cases by either POC-CCA rapid urine test and/or KK.
|
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
|
Number of schistosome infection using serology and molecular as additional examination to disambiguate discordant findings between KK and POC-CCA.
|
1 year
|
To assess risk factors related to human schistosome infections.
Time Frame: 1 year
|
Risk factors will be determined by estimating the odds ratio for each potential risk factor against the Reference Method results.
|
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
|
Proportion of soil transmitted helminth infections
|
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
|
Association between the color intensity of the POC-CCA rapid urine test and the schistosome EPGs of stool.
|
1 year
|
To assess antibody response to schistosome infection.
Time Frame: 1 year
|
Antibody response to schistosome infection.
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Muhammad Karyana, dr. MKes, Ina-Respond
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INA105
- U1111-1263-2399 (Other Identifier: WHO UTN Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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