INA105 - SchisCCA
Tahapan Penelitian : Initial
Sponsor:
National Institute of Health Research and Development (NIHRD), Indonesia and The National Institute of Allergy and Infectious Disease, United State
Mitra Pelaksana:
INA-RESPOND Network
No Registry
INA-0BBB401
Tanggal Input Registry : 14-03-2019
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-07-2019 |
| Outcome Primer | To estimate the accuracy of the schistosomiasis point-of-care circulating cathodic antigen (POC CCA) urine test for monitoring Schistosoma japonicum infection. |
| Outcome Skunder | 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, to 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 helminths infection (STH), i.e. roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and hookworms (Necator americanus and Ancylostoma duodenale) in this population. |
| Descriptive Information | |
| Judul Penelitian Popular | INA105 - SchisCCA |
| Judul Penelitian Ilmiah | Validation of the Schistosomiasis Point-of-Care Circulating Cathdic Antigen (POC-CCA) Rapid Urine Test for Qualitative Detection of Schistosoma japonicum |
| Jenis Penelitian | Observational |
| Intervensi | N/A |
| Jumlah Subyek Penelitian | 10000 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Reside in schistosomiasis affected areas for at least 8 weeks. 2. Age ≥2 years. 3. 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. 4. Willing to comply with the study procedures. 5. Agrees to the collection and storage of specimens.Exclusion Criteria: None |
| Administrative Information | |
| Nomor Persetujuan Etik | LB.02.01/2/KE.027/2019 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | INA-RESPOND |
| Contact Person | dr. Muhammad Karyana, MKes, Telp. +622142879189 email. mkaryana@ina-respond.net |