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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 : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 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 to estimate the accuracy of the schistosomiasis point-of-care circulating cathodic antigen (POC CCA) urine test for monitoring S. japonicum infection by enrolling individuals aged ≥2 years living in the selected households will be invited to participate in the study (pediatric <18 years old will be invited through their parent/guardian) at Lindu, Napu and Bada regions of Central Sulawesi of highest S. japonicum infection prevalence. This study will be conducted in two stages, in the first stage, participants will be recruited from 10 villages of highest S. japonicum infection prevalence. A futility analysis will be conducted after stage one. If a decision is made to proceed with stage 2, additional participants will be recruited.

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 update existing epidemiologic, risk factor and mapping of human, snail and animal infections.
  2. To identify high infection risk areas with the updated data.
  3. To assess correlations between spatial parameters and other risk factors related to human schistosome infections.
  4. To assess rates of positive testing by POC-CCA rapid urine test, Kato Katz stool microscopies, serology, and molecular methods (PCR).
  5. To evaluate the impact of abnormal urinary findings, i.e. hematuria and markers of urinary tract infections, on POC-CCA rapid urine test results.
  6. To evaluate the efficacy of praziquantel administered through local primary health centers (Puskesmas).
  7. To estimate the prevalence of soil transmitted helminth infections (STH), i.e. roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and hookworms (Necator americanus and Ancylostoma duodenale) in this population.

If the target enrollment includes 30 infected participants by Kato Katz multiple stool microscopies, with the assumption of 0.3% prevalence and estimated precision of ±15-20%, up to 10,000 participants will be needed.


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Study Type : Observational
Estimated Enrollment : 10000 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
Estimated Study Start Date : July 1, 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 update existing epidemiologic, risk factor and mapping of human, snail and animal infections. [ Time Frame: 1 year ]
    Updated epidemiologic data (prevalence, age and sex distribution of schistosomiasis cases), risk factor and mapping of human, snail and animal infections.

  2. To identify high infection risk areas with the updated data [ Time Frame: 1 year ]
    Using device (GPS/GIS) to record the location of source workplace, school, source of water and other risk factors related to human shistosome infections

  3. To assess correlations between spatial parameters and other risk factors related to human schistosome infections. [ Time Frame: 1 year ]
    Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the POC-CCA rapid urine test.

  4. To assess rates of positive testing by POC-CCA rapid urine test, Kato Katz stool microscopies, 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.

  5. To evaluate the impact of abnormal urinary findings, i.e. hematuria and markers of urinary tract infections, 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.

  6. To evaluate the efficacy of praziquantel administered through 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 Kato Katz multiple stool microscopies.

  7. To estimate the prevalence 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 ]
    Prevalence of soil transmitted helminth infections.


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


Information from the National Library of Medicine

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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:


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 Not yet 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: March 12, 2019
Last Verified: March 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