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

NCT03870204 | Completed

• 2 other identifiers: INA105U1111-1263-2399
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged ≥2 Years in Schistosomiasis Affected Areas

Keywords

Schistosoma japonicum

Outcome Measures

Primary Outcomes (1)

• To estimate the accuracy of the schistosomiasis point-of-care circulating cathodic antigen (POC CCA) urine test for monitoring Schistosoma japonicum infection

  * 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.

  1 year

Secondary Outcomes (8)

• To assess rates of positive testing by POC-CCA rapid urine test, serology, and molecular methods (PCR).

  1 year

• 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.

  1 year

• To evaluate the efficacy of praziquantel administered by local primary health centers (Puskesmas).

  1 year

• To assess number of schistosome infection using serology and molecular (PCR) as additional tests to disambiguate discordant results between KK and POC-CCA.

  1 year

• To assess risk factors related to human schistosome infections.

  1 year

Interventions

POC-CCA rapid urine test DIAGNOSTIC_TEST

Fresh urine samples will be tested by POC-CCA

Also known as: Kato-Katz, ELISA, and PCR

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Schistosomiasis affected areas are in Lindu, Napu and Bada Valley of Central Sulawesi, Indonesia.

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Ina-Respond: lead
• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Donggala Research and Development (R&D) Center, Ministry of Health of Indonesia

Donggala, Central of Sulawesi, 94353, Indonesia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and stool at visit 1 and 3

MeSH Terms

Conditions

Schistosomiasis japonica

Condition Hierarchy (Ancestors)

Schistosomiasis; Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Muhammad Karyana, dr. MKes

  Ina-Respond

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: September 4, 2019
• Primary Completion: July 2, 2020
• Study Completion: July 2, 2020
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)