Randomized Trial of Erythropoietin During Cerebral Malaria
NCT ID: NCT00697164
Last Updated: 2008-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2007-10-31
2009-03-31
Brief Summary
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Cerebral malaria leading to seizure and coma is associated with severe intracranial hypertension caused by brain-swelling. Recent imaging and post-mortem findings in adult cerebral malaria have confirmed the presence of diffuse cerebral oedema with thalamic and cerebellar white matter hypoattenuation, diffuse petechial hemorrhages and symmetric ischemic changes involving the thalamus and the cerebellum. However, the nature of the pathogenetic processes leading to cerebral malaria is incompletely understood but mechanisms linking cytokines with endothelial cells activation in the cerebral microvasculature have been recently stressed. The effect of new neuroprotective therapies has not yet been investigated, although the manifestations of cerebral malaria partly share features with neurological stroke or acute non-specific neurological disorders. The hormone erythropoietin (EPO) is probably one of the more enthusiastic drugs in this area.
EPO is as a member of type I cytokine superfamily with multiple functions, including a prominent role for erythropoiesis and neuroprotection. Systematically administered EPO crosses the blood brain barrier via the abundant expression of EPO receptors at brain capillaries, and acts as an anti-apoptotic and cytoprotective cytokine. Moreover, EPO prevents inflammation by inhibiting pro-inflammatory cytokines including TNFα, preserves endothelial cells integrity and prevents blood-brain barrier permeability. We propose a randomized clinical trial to investigate the safety and efficacy of EPO in patients presenting cerebral malaria and hospitalized at Gabriel Toure hospital, Bamako, Mali, to reduce the incidence of premature death in hospitalized patients.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Patients in group I received intravenous quinine followed by oral ACT for a total period of 6 days.
Placebo
Saline Admission, day 1, day 2 3 days
2
Patients in group II received antimalarial drug as in group I and in addition 1500U/kg/day of rHUEPO for the initial 3 days.
Erythropoietin
Erythropoietin, 1500 U/kg/day Admission, day 1, day 2 3 days
Interventions
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Placebo
Saline Admission, day 1, day 2 3 days
Erythropoietin
Erythropoietin, 1500 U/kg/day Admission, day 1, day 2 3 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Severe cerebral malaria due to Plasmodium falciparum
* Coma (Blantyre score \<3)
* Enlightened assessment
Exclusion Criteria
* Presence of another obvious affection being able to explain the state of the patient
* Negative malaria test (thick smear / thin smear)
* Severe anaemia
6 Months
15 Years
ALL
No
Sponsors
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Claude Bernard University
OTHER
Responsible Party
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Claude Bernard University, Malaria Research Unit
Principal Investigators
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Stephane PICOT, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Claude Bernard University, Malaria Research Unit
Locations
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Gabriel Toure Hospital
Bamako, , Mali
Countries
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Central Contacts
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Facility Contacts
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Ogobara K DOUMBO, MD PhD
Role: primary
Salimata KONATE, MD
Role: backup
References
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Bienvenu AL, Ferrandiz J, Kaiser K, Latour C, Picot S. Artesunate-erythropoietin combination for murine cerebral malaria treatment. Acta Trop. 2008 May;106(2):104-8. doi: 10.1016/j.actatropica.2008.02.001. Epub 2008 Feb 15.
Picot S, Bienvenu AL, Konate S, Sissoko S, Barry A, Diarra E, Bamba K, Djimde A, Doumbo OK. Safety of epoietin beta-quinine drug combination in children with cerebral malaria in Mali. Malar J. 2009 Jul 24;8:169. doi: 10.1186/1475-2875-8-169.
Other Identifiers
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2516114389
Identifier Type: -
Identifier Source: org_study_id