Reducing the risk of Plasmodium vivax relapse after acute Plasmodium falciparum malaria in co-endemic areas - a randomized controlled trial (PRIMA STUDY) Site: East Nusa Tenggara, Indonesia
Tahapan Penelitian : Initial
Sponsor:
Menzies School of Health Research, Australia
Mitra Pelaksana:
Fakultas Kedokteran Universitas Indonesia (FKUI); Lembaga Biologi Molekuler Eijkman (LBME); Eijkman Oxford Clinical research Unit (EOCRU)
No Registry
INA-BB6K0Q7
Tanggal Input Registry : 21-10-2020
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-06-2021 |
| Outcome Primer | The cumulative incidence of P. vivax malaria at day 63 in patients enrolled with P. falciparum malaria infection treated with DHA-PPQ with or without PQ. |
| Outcome Skunder | 1) Insiden kumulatif malaria P. vivax yang bergejala pada hari ke-28 dan ke-42 pada subyek dengan infeksi malaria P. falciparum. 2) Risiko kejadian malaria P. falciparum asimtomatik pada hari ke 28, 42 dan 63 pada subyek dengan infeksi malaria P. falciparum. |
| Descriptive Information | |
| Judul Penelitian Popular | Reducing the risk of Plasmodium vivax relapse after acute Plasmodium falciparum malaria in co-endemic areas - a randomized controlled trial (PRIMA STUDY) Site: East Nusa Tenggara, Indonesia |
| Judul Penelitian Ilmiah | Reducing the risk of Plasmodium vivax relapse after acute Plasmodium falciparum malaria in co-endemic areas - a randomized controlled trial Site: East Nusa Tenggara, Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Dihydroartemisinin-Piperaquine (DHA-PPQ) according to national recommendation (3 days) + Primaquine (PQ) 1 mg/kg/day (7 days) |
| Jumlah Subyek Penelitian | 100 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Microscopically patent P. falciparum parasitemia mono-infection 2. Fever (axillary temperature ≥37.50C) or history of fever in preceding 48 hours 3. Age >12 months 4. G6PD-normal as defined by the Biosensor (SD Bioline, South Korea) at ≥70% of the adjusted male median enzymatic activity (AMM) for the study site 5. Freely provides written informed consent/assent to participate 6. Able to adhere to necessary study proceduresExclusion Criteria: 1. Presents clinical or laboratory signs of severe malaria 2. Peripheral blood Hb |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-357/UN2.F1/ETIK/PPM.00.02/2020 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | FKUI REF.20-03-0370/OXTREC 65-19/INPRIMA001 |
| Contact Person | Michael Christian |