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Randomized Trial of Erythropoietin During Cerebral Malaria (EPOMAL)
This study is currently recruiting participants.
Study NCT00697164   Information provided by Claude Bernard University
First Received: June 11, 2008   Last Updated: June 12, 2008   History of Changes

June 11, 2008
June 12, 2008
October 2007
December 2008   (final data collection date for primary outcome measure)
Survival [ Time Frame: day 5 post-inclusion ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00697164 on ClinicalTrials.gov Archive Site
 
 
 
Randomized Trial of Erythropoietin During Cerebral Malaria
Randomized Trial of Erythropoietin to Prevent Death From Cerebral Impairment During Severe Malaria

Malaria remains one of the most common life-threatening illnesses in the tropics with a dramatic toll of more than one million deaths each year. A majority of malaria cases are non-complicated and only few evolve towards severe malaria resulting from the combination of parasite-specific virulence factors and host inflammatory responses. Cerebral malaria (CM) kills more than 1 million African children each year. CM carries a fatality rate of about 20% in adults, higher in children, despite timely and adequate chemotherapy. Moreover, the more rapid clearance of parasitaemia with new antimalarial drugs is not associated with improved survival, suggesting the potential interest for adjunctive therapies in the early phase of the disease.

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.

 
Phase II, Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Cerebral Malaria
  • Drug: Placebo
  • Drug: Erythropoietin
  • Placebo Comparator: Patients in group I received intravenous quinine followed by oral ACT for a total period of 6 days.
  • Experimental: Patients in group II received antimalarial drug as in group I and in addition 1500U/kg/day of rHUEPO for the initial 3 days.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
March 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children between 6 months and 14 years old
  • Severe cerebral malaria due to Plasmodium falciparum
  • Coma (Blantyre score <3)
  • Enlightened assessment

Exclusion Criteria:

  • Any case of participation refusal
  • Presence of another obvious affection being able to explain the state of the patient
  • Negative malaria test (thick smear / thin smear)
  • Severe anaemia
Both
6 Months to 15 Years
No
Contact: Stephane PICOT, MD PhD 33-4-7877-7502 stephane.picot@sante.univ-lyon1.fr
Contact: Anne-Lise BIENVENU, PharmD PhD 33-4-7877-7591 anne-lise.bienvenu@recherche.univ-lyon1.fr
Mali
 
NCT00697164
PICOT/MD PhD, Claude Bernard University, Malaria Research Unit
2516114389
Claude Bernard University
 
Principal Investigator: Stephane PICOT, MD PhD Claude Bernard University, Malaria Research Unit
Claude Bernard University
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP