Anaemia Clinical Trial
— DHARTOfficial title:
Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic o | Kinshasa School of Public Health | Kinshasa |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Kinshasa School of Public Health |
Congo, The Democratic Republic of the,
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 |
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