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

NCT02092766 | Completed Phase 4

• 1 other identifier: KIMORU005
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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

Keywords

malaria; anaemia; artesunate

Outcome Measures

Primary Outcomes (1)

• Late onset anaemia

  Late onset anaemia in this study is defined as a ≥10% drop in haemoglobin on any previous measurement anytime between day 7 and 42

  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

Study Arms (2)

IV artesunate

EXPERIMENTAL

Intravenous artesunate 2.4 mg/kg body weight STAT, then 2.4 mg/kg at 12, 24, 48 and 72 hours (5 doses total)

Drug: artesunate

IV quinine

ACTIVE COMPARATOR

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)

Drug: quinine

Interventions

artesunate DRUG

IV artesunate

quinine DRUG

IV quinine

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Kinshasa School of Public Health: collaborator

Study Sites (1)

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Location

Related Publications (1)

• 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.

  PMID: 28818049 DERIVED

MeSH Terms

Conditions

Anemia; Malaria

Interventions

Artesunate; Quinine

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 20, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

DE (1)