Status:
COMPLETED
Hyperphenylalaninemia in Cerebral Malaria
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Hubert Kairuki Memorial University
Duke University
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
6-6 years
Brief Summary
The purpose of this study is to see if children, who develop coma from malaria, are not making enough of a vitamin-like chemical, tetrahydrobiopterin (BH4), which is required for the brain to function...
Detailed Description
The mortality in severe malaria remains between 12-30% despite antimalarial therapy. The overwhelming majority of deaths from malaria occur in children in impoverished countries of the world with cere...
Eligibility Criteria
Inclusion
- Uncomplicated malaria (UM)
- Age between 6 months and 6 years, male and female.
- P. falciparum parasitemia (greater than or equal to 10,000 trophozoites/microliter).
- Clinical syndrome consistent with malaria associated with documented fever (axillary temperature greater than or equal to 38 degrees C) or reported history of fever in the last 48 hours with no other cause present.
- No other infection identified (ie. Negative blood and/or urine cultures).
- Commenced oral quinine less than or equal to 8 hours prior to enrollment.
- Parental permission obtained from parent or legal guardian.
- Cerebral Malaria (CM)
- Age between 6 months to 6 years, male and female.
- Coma (Blantyre Coma Score less than or equal to 2) which persists for \> 30 minutes after correction of hypoglycemia and/or seizure.
- Other causes of coma excluded by lumbar puncture.
- Any degree of P. falciparum parasitemia.
- Less than 8 hours since commencement of intravenous quinine (ideally not yet commenced or soon after).
- Parental permission obtained from parent or legal guardian.
- Non-malaria CNS disease (NMC)
- Age between 6 months and 6 years, male and female.
- Non-malaria cause of altered consciousness/coma identified (eg. Meningitis, subarachnoid hemorrhage, trauma, metabolic, toxic, post-ictal febrile seizure).
- Parental permission obtained from parent or legal guardian.
- Healthy Control (HC)
- Age between 6 months and 6 years, male and female.
- No febrile illness within 2 weeks of evaluation.
- No active inflammatory condition identified.
- Parental permission obtained from parent or legal guardian.
- Negative RDT (rapid diagnostic test for malaria).
Exclusion
- Uncomplicated malaria (UM)
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT00338520
Start Date
October 1 2007
End Date
January 1 2012
Last Update
October 22 2012
Active Locations (1)
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1
Hubert Kairuki Memorial University
Dar es Salaam, Tanzania