Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT03870204
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2019-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of POC-CCA Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
Sponsor:
Ina-Respond
Organization:
Study Overview
Official Title:
Validation of the Schistosomiasis Point-of-Care Circulating Cathodic Antigen (POC-CCA) Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SchisCCA
Brief 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). 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
1. To assess rates of positive testing by POC-CCA rapid urine test, serology, and molecular methods (PCR).
2. 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.
3. To evaluate the efficacy of praziquantel administered by local primary health centers (Puskesmas).
4. To assess number of schistosome infection using serology and molecular (PCR) as additional tests to disambiguate discordant results between KK and POC-CCA.
5. To assess risk factors related to human schistosome infections.
6. 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.
7. To assess the association between color intensity of the POC-CCA rapid urine test band and the schistosome eggs per gram (EPG) of stool.
8. 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.
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
1. To assess rates of positive testing by POC-CCA rapid urine test, serology, and molecular methods (PCR).
2. 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.
3. To evaluate the efficacy of praziquantel administered by local primary health centers (Puskesmas).
4. To assess number of schistosome infection using serology and molecular (PCR) as additional tests to disambiguate discordant results between KK and POC-CCA.
5. To assess risk factors related to human schistosome infections.
6. 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.
7. To assess the association between color intensity of the POC-CCA rapid urine test band and the schistosome eggs per gram (EPG) of stool.
8. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1263-2399 | OTHER | WHO UTN Number | View |