Malaria, Malaria,Falciparum, Malaria, Vivax
Conditions
Brief summary
This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.
Detailed description
Plasmodium vivax is associated with recurrent infections weeks or months following the acute infection due to reactivation of dormant liver stages. Recurrent infections can be associated with a febrile illness, cumulative risk of severe anaemia, direct and indirect mortality, and are the most important source of onward transmission of the parasite. In co-endemic areas, there is a very high risk (up to 50%) of patients representing with P.vivax malaria following treatment of P falciparum. Hence, in co-endemic regions there is a strong rationale for eradicating P.vivax hypnozoites from the liver in patients presenting with uncomplicated P. falciparum infections. The recently completed multicentre IMPROV study compared the efficacy of a 7 day PQ regimen (1.0mg/kg/day for 7 days) with a 14 day regimen (0.5mg/kg/day for 14 days). The 7 day PQ regimen was non-inferior to the 14 day regimen and 5 times more efficacious at reducing P.vivax recurrence than the control. This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in G6PD normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.
Interventions
DRUGprimaquine
Primaquine regimen over 7 days (0.5mg/kg/day for 7 days)
Sponsors
Tribhuvan University, Nepal
Menzies School of Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* P. falciparum and/or vivax infection * Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours * Age \>1 years * G6PD normal by Rapid Diagnostic Test (RDT) as per national guidelines * Written informed consent * Able to comply with all study procedures and timelines
Exclusion criteria
* General danger signs or symptoms of severe malaria * Anaemia, defined as Hb \<8g/dl * Pregnant women as determined by Urine β-HCG pregnancy test * Breast feeding women * Known hypersensitivity to any of the drugs given * Regular use of drugs with haemolytic potential * Blood transfusion within the last 4 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Risk of P. vivax relapse at month 6 | 6 months | The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax and P. falciparum infection. |
Secondary
| Measure | Time frame |
|---|---|
| The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax | 6 months |
| The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. falciparum | 6 month |
| The incidence risk of symptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection | Day 28 |
| The incidence risk of all (symptomatic and asymptomatic) P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection | Day 28 |
| The incidence risk of asymptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection | Day 28 |
Other
| Measure | Time frame |
|---|---|
| The proportion of patients vomiting their medication within 1 hour of administration | 1 h |
| The proportion of patients vomiting any of their PQ doses during the supervised course | 7 - 14days |
| The proportion of adverse events and serious adverse events | 6 month |
| The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion | 6 month |
| Risk of greater than 25% fall in haemoglobin on any day of treatment | 7-14days |
| The incidence risk of an acute drop in Hb of >5g/dl during PQ treatment | 7-14days |
Countries
Nepal
Outcome results
None listed