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Validation of POC-CCA Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum (SchisCCA)

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ClinicalTrials.gov Identifier: NCT03870204
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
National Institute of Health Research and Development (NIHRD), Indonesia
The National Institute of Allergy and Infectious Diseases, United States
Information provided by (Responsible Party):
Ina-Respond

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.

Condition or disease Intervention/treatment
Aged ≥2 Years in Schistosomiasis Affected Areas Diagnostic Test: POC-CCA rapid urine test

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.

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Study Type : Observational
Estimated Enrollment : 232 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the Schistosomiasis Point-of-Care Circulating Cathodic Antigen (POC-CCA) Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: POC-CCA rapid urine test
    Fresh urine samples will be tested by POC-CCA
    Other Name: Kato-Katz, ELISA, and PCR


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  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. [ 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.

  3. 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.

  4. 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.

  5. 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.

  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. [ Time Frame: 1 year ]
    Proportion of soil transmitted helminth infections

  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. [ Time Frame: 1 year ]
    Association between the color intensity of the POC-CCA rapid urine test and the schistosome EPGs of stool.

  8. To assess antibody response to schistosome infection. [ Time Frame: 1 year ]
    Antibody response to schistosome infection.


Biospecimen Retention:   Samples Without DNA
Urine and stool at visit 1 and 3


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Schistosomiasis affected areas are in Lindu, Napu and Bada Valley of Central Sulawesi, Indonesia.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870204


Contacts
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Contact: Muhammad Karyana, dr. MKes +622142879189 mkaryana@ina-respond.net
Contact: Dona Arlinda, dr. +622142879189 arlindona@ina-respond.net

Locations
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Indonesia
Donggala Research and Development (R&D) Center, Ministry of Health of Indonesia Recruiting
Donggala, Central Of Sulawesi, Indonesia, 94353
Contact: Anis Nurwidayati, S.Si., M.Sc    +628114533658      
Principal Investigator: Anis Nurwidayati, S.Si., M.Sc         
Sponsors and Collaborators
Ina-Respond
National Institute of Health Research and Development (NIHRD), Indonesia
The National Institute of Allergy and Infectious Diseases, United States
Investigators
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Principal Investigator: Muhammad Karyana, dr. MKes Ina-Respond

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Responsible Party: Ina-Respond
ClinicalTrials.gov Identifier: NCT03870204     History of Changes
Other Study ID Numbers: INA105
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently we not have any plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ina-Respond:
Schistosoma japonicum
Additional relevant MeSH terms:
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Schistosomiasis
Trematode Infections
Helminthiasis
Parasitic Diseases