Clinical trial NCT02793388: A Trial on Supervised Primaquine Use in Ethiopia
Official title: A Randomized Controlled Trial on Supervised Primaquine Use in Ethiopia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: Armauer Hansen Research Institute, Ethiopia
First posted: 2016-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax or P. falciparum malaria.
timeFrame: 4 months
Secondary outcomes:
measure: The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria infection.
timeFrame: 4 months
measure: The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria infection.
timeFrame: 4 months
measure: The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with malaria due to P. falciparum or P. vivax.
timeFrame: 4 months
measure: The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria.
timeFrame: 4 months
measure: The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria.
timeFrame: 4 months
measure: 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)
timeFrame: 4 months
measure: The incidence risk of any patent or sub-microscopic parasitaemia due to P. vivax or P. falciparum over 4 months in patients
timeFrame: 4 months
measure: The cost-effectiveness of supervised primaquine therapy in terms of cost per malaria episode averted
timeFrame: 1 year
measure: Socio-economic factors for adherence to primaquine treatment
timeFrame: 1 year
Other outcomes:
measure: The proportion of patients vomiting their medication within 1 hour of administration.
timeFrame: 1 day
measure: The proportion of patients vomiting any of their primaquine doses during the 14 day supervised course.
timeFrame: 1 day
measure: The proportion of adverse events and serious adverse events over 4 months in all patients.
timeFrame: 1 year
measure: The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion over 4 months.
timeFrame: 4 months
measure: The incidence risk of an acute drop in Hb >5g/dl within 14 days of starting primaquine treatment.
timeFrame: 14 days
Locations:
Study officials:
References: