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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 June 2015
• Main ID: NCT02092766
• Date of registration: 13/03/2014
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria DHART
• Scientific title: Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria
• Date of first enrolment: June 2014
• Target sample size: 217
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02092766
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Congo, The Democratic Republic of the

Key inclusion & exclusion criteria

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



Age minimum: 6 Months
Age maximum: 14 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Anaemia

Intervention(s)

Drug: quinine

Drug: artesunate

Primary Outcome(s)

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]

Secondary ID(s)

KIMORU005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kinshasa School of Public Health