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Cerebral MalariaPhase 2/3EPOMALNCT00697164

Randomized Trial of Erythropoietin During Cerebral Malaria

A Phase 2/3 study testing Erythropoietin in people with Cerebral Malaria, run by Claude Bernard University at 1 site in Mali.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 6 months to 15 years
Conditions the study is for
Cerebral Malaria
What is being tested?
Erythropoietin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteMali
Study dates
Oct 2007to Mar 2009
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mali1 site, 1 recruiting
  • Gabriel Toure Hospital

    Bamako

    Ogobara K DOUMBO, MD PhD, 223-222-8109, okd@mrtcbko.org

    Salimata KONATE, MD, 223-222-8109, salimata57@yahoo.fr

    Recruiting

Other trials in Mali

About this study

Official title: 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.

Being tested
Placebo, Erythropoietin
Keywords
Malaria, Treatment, Adjunctive, Erythropoietin, Survival
Medical subject headings
Malaria, Cerebral, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Saline Admission, day 1, day 2 3 days

  • ErythropoietinDrug

    Also called Neorecormon

    Erythropoietin, 1500 U/kg/day Admission, day 1, day 2 3 days

Study groups in NCT00697164
Study groupRoleWhat they receive
1Placebo comparatorPatients in group I received intravenous quinine followed by oral ACT for a total period of 6 days.
Receives: Drug: Placebo
2ExperimentalPatients in group II received antimalarial drug as in group I and in addition 1500U/kg/day of rHUEPO for the initial 3 days.
Receives: Drug: Erythropoietin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    Measured: day 5 post-inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionDec 2008 (estimated)
  4. Study completionMar 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00697164
Sponsor's protocol ID
2516114389
Acronym
EPOMAL
Status last verified
Jun 2008
First submitted
11 Jun 2008
Last updated
13 Jun 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18359468
  • 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.

    PubMed 19630971

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Erythropoietin in people with Cerebral Malaria, run by Claude Bernard University at 1 site in Mali.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Stephane PICOT, MD PhD (33-4-7877-7502, stephane.picot@sante.univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: day 5 post-inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00697164, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2008.

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