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

2019-03-15 04:52:22 | BioPortfolio

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.

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.

Study Design

Conditions

Aged ≥2 Years in Schistosomiasis Affected Areas

Intervention

POC-CCA rapid urine test

Location

Donggala Research and Development (R&D) Center, Ministry of Health of Indonesia
Donggala
Central Of Sulawesi
Indonesia
94353

Status

Not yet recruiting

Source

Ina-Respond

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-03-15T04:52:22-0400

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