A Trial on Supervised Primaquine Use in Ethiopia
- Conditions
- Malaria
- Interventions
- Registration Number
- NCT02793388
- Lead Sponsor
- Menzies School of Health Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supervised primaquine arm Supervised primaquine treatment 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. Unsupervised primaquine arm Unsupervised primaquine treatment 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria. 4 months 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 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 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