Clinical trial NCT03870204: Validation of POC-CCA Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
Official title: Validation of the Schistosomiasis Point-of-Care Circulating Cathodic Antigen (POC-CCA) Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aged ≥2 Years in Schistosomiasis Affected Areas
Keywords: Schistosoma japonicum
Lead sponsor: Ina-Respond
Sponsor class: OTHER
Collaborators: name: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2019-03-12
Enrollment: 186
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Schistosomiasis affected areas are in Lindu, Napu and Bada Valley of Central Sulawesi, Indonesia.

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.

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 assess rates of positive testing by POC-CCA rapid urine test, serology, and molecular methods (PCR).
2. 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.
3. To evaluate the efficacy of praziquantel administered by local primary health centers (Puskesmas).
4. To assess number of schistosome infection using serology and molecular (PCR) as additional tests to disambiguate discordant results between KK and POC-CCA.
5. To assess risk factors related to human schistosome infections.
6. To estimate the proportion of soil transmitted helminths infection (STH), i.e. roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and hookworms (Necator americanus and Ancylostoma duodenale) in this population.
7. To assess the association between color intensity of the POC-CCA rapid urine test band and the schistosome eggs per gram (EPG) of stool.
8. To assess antibody response to schistosome infection. The number in the positive KK group will be 40 subjects, with the lowest estimated number is 25 subjects. Additional positive KK based on the re-testing KK results are expected and should increase the size for the positives. For the negatives, we calculated that a ratio of 4:1 negative to positive will be the best fit, thus 160 negative KK subjects will be enrolled. Additional 20% buffer to the negatives (32 negative KK subjects) will also be needed to estimate the specificity of POC-CCA with acceptable 95% CI. In total, we will enroll between 217 to 232 subjects in this study. The study will enroll all positive cases detected by the 2019 stool survey in Napu until the minimum sample size needed is met or until the data collection period has ended.

Eligibility 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:

None.

Primary outcomes:
measure: To estimate the accuracy of the schistosomiasis point-of-care circulating cathodic antigen (POC CCA) urine test for monitoring Schistosoma japonicum infection
timeFrame: 1 year
Secondary outcomes:
measure: To assess rates of positive testing by POC-CCA rapid urine test, serology, and molecular methods (PCR).
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: To evaluate the efficacy of praziquantel administered by local primary health centers (Puskesmas).
timeFrame: 1 year
measure: To assess number of schistosome infection using serology and molecular (PCR) as additional tests to disambiguate discordant results between KK and POC-CCA.
timeFrame: 1 year
measure: To assess risk factors related to human schistosome infections.
timeFrame: 1 year
measure: To estimate the proportion of soil transmitted helminths infection (STH), i.e. roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and hookworms (Necator americanus and Ancylostoma duodenale) in this population.
timeFrame: 1 year
measure: To assess the association between color intensity of the POC-CCA rapid urine test band and the schistosome eggs per gram (EPG) of stool.
timeFrame: 1 year
measure: To assess antibody response to schistosome infection.
timeFrame: 1 year
Other outcomes:
Locations:
city: Donggala
country: Indonesia
facility: Donggala Research and Development (R&D) Center, Ministry of Health of Indonesia
state: Central Of Sulawesi
Study officials:
affiliation: Ina-Respond
name: Muhammad Karyana, dr. MKes
role: PRINCIPAL_INVESTIGATOR
References: