Anaemia | Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria
Anaemia research study
What is the primary objective of this study?
Delayed anaemia has been reported in European travellers with malaria cured by artesunate. Although no deaths related to this delayed anaemia have been reported so far, blood transfusion has been necessary in some affected patients. Recent observations suggest that this episodes of anaemia also occurs in endemic countries. The aim of this trial is to assess the incidence of late onset anaemia after treatment with intravenous artesunate compared to intravenous quinine, to identify patients at risk and to clarify the causes of this delayed anaemia.
Who is eligible to participate?
Inclusion Criteria: - Age > 6 months and ≤ 14 years - Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or mixed with non-falciparum species - Asexual P. falciparum parasitaemia ≥ 100,000/uL and ≤500,000/uL - Haemoglobin ≥5.0 g/dL - Parents/guardians agree to hospitalize the child for the length of treatment (3 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42 - Signed consent from the guardian/parents Exclusion Criteria: - Body weight ≤ 5 kg - Severe malaria or signs of severe malaria as defined by WHO Guidelines 2013 - History of hypersensitivity or contraindication to quinine or artesunate - A clear history of adequate antimalarial treatment in the preceding 24 hours with drugs expected to be effective - Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the patient treatment or results of the study - Participation in another clinical trial
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
IV artesunateIntravenous artesunate 2.4 mg/kg body weight STAT, then 2.4 mg/kg at 12, 24, 48 and 72 hours (5 doses total)
IV quinineIntravenous quinine dihydrochloride 20 mg salt/kg body weight loading dose over 4 hours, then 10 mg/kg over 2 hours 8 hourly until 72 hours (9 doses total)
Start Date: June 2014
Completed Date: April 2015
Phase: Phase 4
Primary Outcome: Late onset anaemia
Study sponsors, principal investigator, and references
Lead Sponsor: University of Oxford
Collaborator: Kinshasa School of Public Health