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NCT03870204: SchisCCA

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

Completed Last updated 2 November 2021
What this trial tests

trial testing POC-CCA rapid urine test in Aged ≥2 Years in Schistosomiasis Affected Areas in 186 participants. Completed in 2 July 2020.

Timeline
4 September 2019
Primary endpoint
2 July 2020
2 July 2020

Quick facts

Lead sponsorIna-Respond
StatusCompleted
Study typeOBSERVATIONAL
Enrollment186
Start date4 September 2019
Primary completion2 July 2020
Estimated completion2 July 2020
Sites1 location across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

Ina-Respond — full company profile →

Who can join

2 and older, any sex, with Aged ≥2 Years in Schistosomiasis Affected Areas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Maintaining international research collaborations in the setting of a pandemic: Approach in Indonesia.
    Karyana M, Kosasih H, Neal AT, Lau CY. · · 2021 · cited 3× · PMID 34326986 · DOI 10.7189/jogh.11.03087

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Other Ina-Respond trials

Trials by the same sponsor.

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