Aged =2 Years in Schistosomiasis Affected Areas Clinical Trial
— SchisCCAOfficial title:
Validation of the Schistosomiasis Point-of-Care Circulating Cathodic Antigen (POC-CCA) Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
| Verified date | October 2021 |
| Source | Ina-Respond |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 186 |
| Est. completion date | July 2, 2020 |
| Est. primary completion date | July 2, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Indonesia | Donggala Research and Development (R&D) Center, Ministry of Health of Indonesia | Donggala | Central Of Sulawesi |
| Lead Sponsor | Collaborator |
|---|---|
| Ina-Respond | National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, The National Institute of Allergy and Infectious Diseases, United States |
Indonesia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | To assess rates of positive testing by POC-CCA rapid urine test, serology, and molecular methods (PCR). | Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the POC-CCA rapid urine test. | 1 year | |
| Secondary | 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. | Sensitivity and specificity of the POC-CCA rapid urine test, when compared to the Reference Method, among individuals with abnormal urinary findings. | 1 year | |
| Secondary | To evaluate the efficacy of praziquantel administered by local primary health centers (Puskesmas). | Evaluation of cure rate (percentage negative) after praziquantel administration to positive cases by either POC-CCA rapid urine test and/or KK. | 1 year | |
| Secondary | To assess number of schistosome infection using serology and molecular (PCR) as additional tests to disambiguate discordant results between KK and POC-CCA. | Number of schistosome infection using serology and molecular as additional examination to disambiguate discordant findings between KK and POC-CCA. | 1 year | |
| Secondary | To assess risk factors related to human schistosome infections. | Risk factors will be determined by estimating the odds ratio for each potential risk factor against the Reference Method results. | 1 year | |
| Secondary | 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. | Proportion of soil transmitted helminth infections | 1 year | |
| Secondary | To assess the association between color intensity of the POC-CCA rapid urine test band and the schistosome eggs per gram (EPG) of stool. | Association between the color intensity of the POC-CCA rapid urine test and the schistosome EPGs of stool. | 1 year | |
| Secondary | To assess antibody response to schistosome infection. | Antibody response to schistosome infection. | 1 year |