A Phase 4 interventional study of Supervised primaquine treatment and Unsupervised primaquine treatment in Malaria, sponsored by Menzies School of Health Research. Withdrawn. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2017-02-08.
Sponsored by Menzies School of Health Research · Phase 4, Interventional, and Treatment
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.
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Exclusion Criteria:
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
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
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.
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.
The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax or P. falciparum malaria.
Time frame: 4 months
The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria infection.
Time frame: 4 months
The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria infection.
Time frame: 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.
Time frame: 4 months
The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria.
Time frame: 4 months
The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria.
Time frame: 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)
Time frame: 4 months
The incidence risk of any patent or sub-microscopic parasitaemia due to P. vivax or P. falciparum over 4 months in patients
Time frame: 4 months
The cost-effectiveness of supervised primaquine therapy in terms of cost per malaria episode averted
Time frame: 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.
Time frame: 1 year
The proportion of patients vomiting their medication within 1 hour of administration.
Time frame: 1 day
The proportion of patients vomiting any of their primaquine doses during the 14 day supervised course.
Time frame: 1 day
The proportion of adverse events and serious adverse events over 4 months in all patients.
Time frame: 1 year
The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion over 4 months.
Time frame: 4 months
The incidence risk of an acute drop in Hb >5g/dl within 14 days of starting primaquine treatment.
Time frame: 14 days
No study locations are listed for this record.
This study is withdrawn, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Menzies School of Health Research