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

Primary Purpose

Anaemia

Status
Completed
Phase
Phase 4
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
artesunate
quinine
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaemia focused on measuring malaria, anaemia, artesunate

Eligibility Criteria

6 Months - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kinshasa School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IV artesunate

IV quinine

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 13, 2014
Last Updated
May 29, 2015
Sponsor
University of Oxford
Collaborators
Kinshasa School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT02092766
Brief Title
Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria
Acronym
DHART
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Kinshasa School of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaemia
Keywords
malaria, anaemia, artesunate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV artesunate
Arm Type
Experimental
Arm Description
Intravenous artesunate 2.4 mg/kg body weight STAT, then 2.4 mg/kg at 12, 24, 48 and 72 hours (5 doses total)
Arm Title
IV quinine
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
artesunate
Intervention Type
Drug
Intervention Name(s)
quinine
Primary Outcome Measure Information:
Title
Late onset anaemia
Description
Late onset anaemia in this study is defined as a ≥10% drop in haemoglobin on any previous measurement anytime between day 7 and 42
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kinshasa School of Public Health
City
Kinshasa
Country
Congo, The Democratic Republic of the

12. IPD Sharing Statement

Citations:
PubMed Identifier
28818049
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.
Results Reference
derived

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

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