A Trial on Supervised Primaquine Use in Ethiopia

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial on Supervised Primaquine Use in Ethiopia

Conditions
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Malaria

Intervention / Treatment
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* Drug: Supervised primaquine treatment
* Drug: Unsupervised primaquine treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supervised primaquine arm<br>Following standard schizontocidal treatment according to national guidelines and if haemoglobin levels are above 8g/dL and G6PD testing is normal, the patient receives primaquine (0.5mg/kg/day) for 14 days for radical cure. Supervision of primaquine is done on alternate days at home (attended by a home visitor) or at the health centre. | Drug: Supervised primaquine treatment<br>* 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.<br>|
| Active Comparator: Unsupervised primaquine arm<br>Following standard schizontocidal treatment according to national guidelines and if haemoglobin levels are above 8g/dL and G6PD testing is normal, the patient receives primaquine (0.5mg/kg/day) for 14 days for radical cure for self administration. | Drug: Unsupervised primaquine treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. vivax malaria. |  | 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 | Factors are collected through a semi-standardized questionaire. Factors include indicators for economic status, as well as information on educational background. | 1 year |