Clinical trial NCT02092766: Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria
Official title: Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anaemia
Keywords: malaria
anaemia
artesunate
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Kinshasa School of Public Health
First posted: 2014-03-20
Enrollment: 217
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Late onset anaemia
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa School of Public Health
Study officials:
References:
citation: Fanello C, Onyamboko M, Lee SJ, Woodrow C, Setaphan S, Chotivanich K, Buffet P, Jaureguiberry S, Rockett K, Stepniewska K, Day NPJ, White NJ, Dondorp AM. Post-treatment haemolysis in African children with hyperparasitaemic falciparum malaria; a randomized comparison of artesunate and quinine. BMC Infect Dis. 2017 Aug 17;17(1):575. doi: 10.1186/s12879-017-2678-0.