Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GTN2042278 | Other Grant/Funding Number | NHMRC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Curtin University | OTHER |
| University of Melbourne | OTHER |
| Papua New Guinea Institute of Medical Research | OTHER_GOV |
| Arba Minch University |
Not provided
Not provided
Not provided
Not provided
Current treatment regimens to prevent relapsing malaria are too long. A shorter higher dose treatment could improve treatment outcomes, but this needs to be balanced against increased risk of side effects. Recent data from a trial in children in Papua New Guinea (PNG) suggests a shortened treatment of 3 days is safe and effective. Our multicentre trial will assess the safety and efficacy of an ultra-short primaquine course. This trial is expected to directly influence global treatment policies.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose Short-course Primaquine (PQ7) | Active Comparator | Participants in this arm will receive a high-dose, short-course primaquine regimen (PQ7), consisting of a total dose of 7 mg/kg administered as 1 mg/kg once daily in the morning for 7 days (Day 0-6). A matching placebo will be given in the evening on the first three days (Day 0-2). |
|
| High dose ultra- short course Primaquine (PQ 3.5) | Experimental | Participants in this arm will receive a high-dose, ultra-short primaquine regimen (PQ3.5), consisting of a total dose of 7 mg/kg administered as 1 mg/kg twice daily for 3.5 days (Day 0-2 morning and evening doses, and Day 3 morning dose). A matching placebo will be given as the morning dose on Days 4-6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose ultra short Primaquine | Drug | High-dose, ultra-short primaquine (PQ3.5): 7mg/kg total dose given as 1mg/kg twice daily over 3.5 days (day 0, 1 and 2 morning and evening doses, and day 3 morning dose) followed by placebo as morning doses on day 4, 5 and 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence risk of any recurrent vivax parasitaemia within 4 months. | The incidence risk (time to first event) of any recurrent P. vivax parasitaemia within 4 months as determined by microscopy | 4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence risk of any P. vivax parasitaemia within 6 months. | The incidence risk (time to first event) of any P. vivax parasitaemia within 6 months as determined by microscopy | 6 months |
| Incidence of haemoglobin drop >25% to <7g/dl within 14 days of treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kamala Thriemer, Professor | Contact | +61889468644 | Kamala.Ley-Thriemer@menzies.edu.au | |
| Hellen Mnjala, MSc | Contact | +61889468675 | hellen.mnjala@menzies.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Kamala Thriemer, Professor | Menzies School of Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arba Minch University | Arba Minch | Arba Minch | Ethiopia |
De-identified individual participant data (IPD) underlying the results reported in this trial will be shared. This will include baseline characteristics, outcome measures, and adverse events data. Data will be available beginning [6-12 months] after publication of the primary results, and will be shared with qualified researchers upon reasonable request, following approval of a research proposal and completion of a data access agreement. Supporting documents such as the study protocol and statistical analysis plan will also be provided.
Not provided
All the investigators involved in the study.
Not provided
Not provided
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
Not provided
Not provided
| OTHER |
| Jimma University | OTHER |
| Universitas Sumatera Utara | OTHER |
| Aga Khan University | OTHER |
| PathWest Laboratory Medicine WA | OTHER_GOV |
Health care facility based, randomised, controlled, double blinded, trial with 2 arms
Not provided
Not provided
Not provided
| Placebo | Other | Matching placebo administered according to the arm schedule. Morning dose on Days 4-6 for PQ3.5 arm and Evening dose on the first 3 days for PQ 7 arm). |
|
Number of participants experiencing a haemoglobin decrease of >25% from baseline resulting in Hb<7g/dl |
| 0-14 days |
| Incidence of moderate anaemia within 14 days after starting primaquine | Number of participants developing haemoglobin >=5g/dl and <7g/dl within 14 days after treatment initiation | 0-14 days |
| Incidence of severe anaemia within 14 days after starting Primaquine | Number of participants developing haemoglobin <5g/dl within 14 days of treatment initiation. | 0-14 days |
| • The proportion of patients requiring blood transfusion within the 6 months follow up period. | Participants requiring transfusion due to haemolysis or severe anaemia | 6 months |
| The incidence risk of symptomatic P. vivax parasitaemia within 4 months. | The incidence risk (time to first event) of symptomatic P. vivax parasitaemia within 4 months as determined by microscopy. | 4 months |
| Proportion of adverse events within 14 days. | The number and proportion of adverse events within 14 days after start of treatment | 14 days |
| The number and proportion of serious adverse events. | The number and proportion of serious adverse events. | 6 Months |
| Jimma University | Jimma | Jimma | Ethiopia |
|
| Universitas Sumatera | Bandar Lampung | Lampung | Indonesia |
|
| Aga Khan University, Karachi | Karachi | Thatta | Pakistan |
|
| Papua New Guinea Institute of Medical Research | Port Moresby | Magang | Papua New Guinea |
|
| D000079426 |
| Vector Borne Diseases |