Short COurse PrimaquinE for the radical cure of P. vivax (SCOPE)
Tahapan Penelitian : Initial
Sponsor:
Menzies School of Health Research, Charles Darwin University
Mitra Pelaksana:
Menzies School of Health Research, Australia
Burnet Institute, Australia
Institute of Tropical Medicine, Belgium
University of Melbourne
No Registry
INA-2NWRPQ47
Tanggal Input Registry : 25-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 25-03-2025 |
| Outcome Primer | Proportion of patients experiencing at least one SAE or AESI during treatment |
| Outcome Skunder | The proportion of patients experiencing AESI, stopping PQ before completion, receiving correct treatment based on G6PD activity, or reviewed on day 3 and day 7 |
| Descriptive Information | |
| Judul Penelitian Popular | Short COurse PrimaquinE for the radical cure of P. vivax (SCOPE) |
| Judul Penelitian Ilmiah | Feasibility of high daily dose short course primaquine after G6PD testing for the radical cure of Plasmodium vivax malaria |
| Jenis Penelitian | Interventional |
| Intervensi | Primaquine |
| Jumlah Subyek Penelitian | 500 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Patients diagnosed with P. vivax malaria Patients eligible for PQ (Primaquine) treatment G6PD Activity >70% → Eligible for PQ7 G6PD Activity 30-70% → Eligible for PQ14 G6PD ActivityExclusion Criteria: Pregnant women (confirmed or unknown pregnancy status), Lactating women, Infants younger than 6 months or weighing |
| Administrative Information | |
| Nomor Persetujuan Etik | Pending |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | Vicky Achmad Ginanjar |