Anaemia
Conditions
Keywords
malaria, anaemia, artesunate
Brief summary
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.
Interventions
DRUGartesunate
DRUGquinine
Sponsors
Kinshasa School of Public Health
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late onset anaemia | 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 |
Countries
Democratic Republic of the Congo
Outcome results
None listed