Vivax Malaria
Conditions
Brief summary
The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question\[s\] it aims to answer are: * is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days) * is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg) * is the tolerability and safety of TQRevised acceptable * is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.
Interventions
DRUGTafenoquine
oral treatment
DRUGPrimaquine
oral treatment
Sponsors
University of Melbourne
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Arba Minch University
Addis Ababa University
Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia
Curtin University
Papua New Guinea Institute of Medical Research
Menzies School of Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* P. vivax peripheral parasitaemia (mono-infection) * G6PD normal status (G6PD activity ≥70% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK)) * Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours * Written informed consent * Living in the study area and willing to be followed for six months
Exclusion criteria
* Danger signs or symptoms of severe malaria * Anaemia (defined as Hb \<8g/dl) * Pregnant or lactating females * Regular use of drugs with haemolytic potential * Known hypersensitivity to any of the study drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence risk of vivax parasitaemia | 4 months | The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy. * compared between TQRevised and the PQ7 (non-inferiority) * compared between TQRevised and TQStandard (superiority) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence risk of symptomatic vivax parasitaemia | 4 months | The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 4 months follow up period as determined by microscopy |
| The incidence rate of vivax parasitaemia | 6 months | The incidence rate (events per person-time) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy |
| The incidence rate of symptomatic vivax parasitaemia | 6 months | The incidence rate (events per person-time) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy |
| The incidence risk of vivax parasitaemia | 4 months | The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy compared between TQStandard and PQ7 |
| The incidence risk of an acute drop in Hb | 7 and 14 days | The incidence risk of an acute drop in Hb of \>25% to \<7g/dl within 7 and 14 days of starting treatment |
| Adverse events | 42 days | The number and proportion of adverse and serious adverse events in each arm within 42 days after start of treatment |
| Meth Hb concentration | day 7 | day 7 methaemoglobin concentration |
| The incidence risk of anaemia | 7 and 14 days, 6 months | The incidence risk of developing severe anaemia (Hb \< 5g/dl) or moderate (5g/dl and \<7g/dl) anaemia within 7 and 14 days of starting treatment and/or requiring blood transfusion within the 6 months follow up period |
Countries
Brazil, Ethiopia, Indonesia, Papua New Guinea
Contacts
Primary ContactHellen Mnjala
Backup Contactkamala K Thriemer
Outcome results
None listed