Malaria
Conditions
Keywords
An ultra-short course of primaquine for the radical cure of vivax malaria, PRIMUS
Brief summary
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.
Interventions
DRUGHigh dose ultra short Primaquine
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.
OTHERPlacebo
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).
Sponsors
Menzies School of Health Research
Curtin University
University of Melbourne
Papua New Guinea Institute of Medical Research
Arba Minch University
Jimma University
Universitas Sumatera Utara
Aga Khan University
PathWest Laboratory Medicine WA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Health care facility based, randomised, controlled, double blinded, trial with 2 arms
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* P. vivax peripheral parasitaemia as determined by microscopy * G6PD normal status (G6PD activity ≥70% of the site specific adjusted male median as determined by the Standard G6PD (SD Bioline, ROK)) * Fever (temperature ≥37.5°C) or history of fever in the preceding 48 hours, * Age ≥5 years * Bodyweight ≥14kg * Living in the study area and willing to be followed-up for six months
Exclusion criteria
* Signs or symptoms of severe malaria, * Anaemia (defined as Hb \<8g/dl) and measured by the Standard G6PD * Pregnant or lactating * Blood transfusion within the preceding four months * Regular or recent use (last month) of tafenoquine, primaquine or dapsone * Known hypersensitivity to any of the study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence risk of any recurrent vivax parasitaemia within 4 months. | 4 Months | The incidence risk (time to first event) of any recurrent P. vivax parasitaemia within 4 months as determined by microscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence risk of any P. vivax parasitaemia within 6 months. | 6 months | The incidence risk (time to first event) of any P. vivax parasitaemia within 6 months as determined by microscopy |
| Incidence of haemoglobin drop >25% to <7g/dl within 14 days of treatment. | 0-14 days | Number of participants experiencing a haemoglobin decrease of \>25% from baseline resulting in Hb\<7g/dl |
| Incidence of moderate anaemia within 14 days after starting primaquine | 0-14 days | Number of participants developing haemoglobin \>=5g/dl and \<7g/dl within 14 days after treatment initiation |
| Incidence of severe anaemia within 14 days after starting Primaquine | 0-14 days | Number of participants developing haemoglobin \<5g/dl within 14 days of treatment initiation. |
| • The proportion of patients requiring blood transfusion within the 6 months follow up period. | 6 months | Participants requiring transfusion due to haemolysis or severe anaemia |
| The incidence risk of symptomatic P. vivax parasitaemia within 4 months. | 4 months | The incidence risk (time to first event) of symptomatic P. vivax parasitaemia within 4 months as determined by microscopy. |
| Proportion of adverse events within 14 days. | 14 days | The number and proportion of adverse events within 14 days after start of treatment |
| The number and proportion of serious adverse events. | 6 Months | The number and proportion of serious adverse events. |
Countries
Ethiopia, Indonesia, Pakistan, Papua New Guinea
Contacts
CONTACTKamala Thriemer, Professor
CONTACTHellen Mnjala, MSc
PRINCIPAL_INVESTIGATORKamala Thriemer, Professor
Menzies School of Health Research
Outcome results
None listed