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

NCT03870204 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 186

Last updated 2021-11-02

No results posted yet for this study

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.

Conditions

  • Aged ≥2 Years in Schistosomiasis Affected Areas

Interventions

DIAGNOSTIC_TEST

POC-CCA rapid urine test

Fresh urine samples will be tested by POC-CCA

Sponsors & Collaborators

  • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Ina-Respond

    lead OTHER

Principal Investigators

  • Muhammad Karyana, dr. MKes · Ina-Respond

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2020-07-02
Completion
2020-07-02

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03870204 on ClinicalTrials.gov