Skip to main content
OpenTrials
Completed

NCT Number: NCT02092766

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anaemia Anemia Hematologic Diseases Hemic and Lymphatic Diseases Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artesunate

Drug

Quinine

Drug

Primary outcomes

  1. 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

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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Kinshasa School of Public Health

Registry information

Official study title

Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria

Acronym: DHART

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 20, 2014
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.