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

NCT ID: NCT02092766

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-04-30

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.

Conditions

Anaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

artesunate

Intervention Type: DRUG

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)

Group Type: ACTIVE_COMPARATOR

quinine

Intervention Type: DRUG

Interventions

artesunate

Intervention Type: DRUG

quinine

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kinshasa School of Public Health

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kinshasa School of Public Health

Kinshasa, , Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

References

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.

Reference Type: DERIVED

PMID: 28818049 (View on PubMed)

Other Identifiers

KIMORU005

Identifier Type: -

Identifier Source: org_study_id