Malaria
Conditions
Brief summary
This is a randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. In co-endemic regions, the risk of P. vivax relapse following treatment for P. falciparum is high. Hence patients infected with either P. vivax or P. falciparum will be included in the study. The study will be conducted in Ethiopia. Participants will be enrolled at health centres and provided with the recommended schizontocidal treatment plus primaquine radical cure which will be either supervised or unsupervised according to randomisation. Participants will be followed up for four months and assessed at regular intervals for the presence of patent and sub-patent malaria. The outcome of the study will contribute to an improved treatment scheme for uncomplicated malaria in this area.
Interventions
DRUGSupervised primaquine treatment
Following schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided supervised every other day.
DRUGUnsupervised primaquine treatment
Following schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided unsupervised.
Sponsors
Menzies School of Health Research
Armauer Hansen Research Institute, Ethiopia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours * Age \>5 years * Weight \>5kg * Written informed consent * Living in the study area and willing to be followed for 4 months
Exclusion criteria
* General danger signs or symptoms of severe malaria (Appendix 17.1 and 17.2) * 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 * Living in the same household as an individual enrolled into the study in the last 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax or P. falciparum malaria. | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with malaria due to P. falciparum or P. vivax. | 4 months | — |
| The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria. | 4 months | — |
| The incidence risk of patent or sub-microscopic P. vivax malaria over 4 months in patients enrolled with malaria (sub-group analysis for patients recruited with P. vivax infection and P. falciparum infection) | 4 months | — |
| The incidence risk of any patent or sub-microscopic parasitaemia due to P. vivax or P. falciparum over 4 months in patients | 4 months | — |
| The cost-effectiveness of supervised primaquine therapy in terms of cost per malaria episode averted | 1 year | — |
| Socio-economic factors for adherence to primaquine treatment | 1 year | Factors are collected through a semi-standardized questionaire. Factors include indicators for economic status, as well as information on educational background. |
| The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria infection. | 4 months | — |
| The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria infection. | 4 months | — |
| The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria. | 4 months | — |
Other
| Measure | Time frame |
|---|---|
| The proportion of adverse events and serious adverse events over 4 months in all patients. | 1 year |
| The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion over 4 months. | 4 months |
| The incidence risk of an acute drop in Hb >5g/dl within 14 days of starting primaquine treatment. | 14 days |
| The proportion of patients vomiting their medication within 1 hour of administration. | 1 day |
| The proportion of patients vomiting any of their primaquine doses during the 14 day supervised course. | 1 day |
Outcome results
None listed