Health Trials

An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria

ConditionMalaria
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5+
SponsorMenzies School of Health Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Other intervention

    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).

Treatment groups

1,019 Participants
are divided into 2 treatment groups
Group A: High-dose Short-course Primaquine (PQ7)Active comparator 2 interventions
Group B: High dose ultra- short course Primaquine (PQ 3.5)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
4 Months

Secondary outcomes

1

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

Time frame
6 months
2

Incidence of haemoglobin drop >25% to <7g/dl within 14 days of treatment.

Number of participants experiencing a haemoglobin decrease of \>25% from baseline resulting in Hb\<7g/dl

Time frame
0-14 days
3

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

Time frame
0-14 days
4

Incidence of severe anaemia within 14 days after starting Primaquine

Number of participants developing haemoglobin \<5g/dl within 14 days of treatment initiation.

Time frame
0-14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Menzies School of Health Research

Lead sponsor

Curtin University

Collaborator

University of Melbourne

Collaborator

Papua New Guinea Institute of Medical Research

Collaborator

Arba Minch University

Collaborator

Jimma University

Collaborator

Universitas Sumatera Utara

Collaborator

Aga Khan University

Collaborator

PathWest Laboratory Medicine WA

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: