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

Information source: University of Oxford
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anaemia

Intervention: artesunate (Drug); quinine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Oxford


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.

Clinical Details

Official title: Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Late onset anaemia


Minimum age: 6 Months. Maximum age: 14 Years. Gender(s): Both.


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

Locations and Contacts

Kinshasa School of Public Health, Kinshasa, Congo, The Democratic Republic of the
Additional Information

Starting date: June 2014
Last updated: May 29, 2015

Page last updated: August 23, 2015

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