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

Anaemia Clinical Trial

— DHART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092766
• Other study ID #: KIMORU005
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2014
• Last updated: May 29, 2015
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: University of Oxford
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaemia
• Anemia

Intervention

Drug:
• artesunate

• quinine

Locations

Country	Name	City	State
Congo, The Democratic Republic o	Kinshasa School of Public Health	Kinshasa

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Kinshasa School of Public Health

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes