Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria

Overview

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.

Full Title of Study: “Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2015

Interventions

  • Drug: artesunate
  • Drug: quinine

Arms, Groups and Cohorts

  • Experimental: IV artesunate
    • Intravenous artesunate 2.4 mg/kg body weight STAT, then 2.4 mg/kg at 12, 24, 48 and 72 hours (5 doses total)
  • Active Comparator: IV quinine
    • Intravenous 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)

Clinical Trial Outcome Measures

Primary Measures

  • Late onset anaemia
    • Time Frame: Patients are hospitalized for 4 days or longer if still unwell. After discharge the follow-up consists of 6 weekly visits (time frame 42 days). Late anaemia is measured between 7 and 42 days following the start of antimalarial treatment
    • Late onset anaemia in this study is defined as a ≥10% drop in haemoglobin on any previous measurement anytime between day 7 and 42

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Oxford
  • Collaborator
    • Kinshasa School of Public Health
  • Provider of Information About this Clinical Study
    • Sponsor

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