Clinical Trial: Hyperphenylalaninemia in Cerebral Malaria

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Hyperphenylalaninemia in Cerebral Malaria

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 normally. This information may help to identify new ways to treat malaria in the future. Study participants will include 512 children, ages 6 months to 6 years. Participants will be placed into one of 4 groups: well children; children with mild malaria; children without malaria, but with a medical problem involving the brain that requires a lumbar puncture for diagnosis (a procedure in which a needle is placed into an area surrounding the spinal cord and a sample of cerebral spinal fluid is removed); and children with a severe form of malaria affecting the brain called cerebral malaria. Study procedures will include blood samples, urine samples and lumbar puncture, only if necessary for diagnosis as part of standard practice procedures. Participants will be involved in study related procedures for up to 3 weeks.

Detailed Summary: 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 cerebral malaria (CM) and metabolic acidosis as the most important negative prognostic indicators. CM is a serious complication of falciparum malaria. It is characterized by fever, coma (not attributable to hypoglycemia), seizures (not attributable to febrile seizures) and abnormalities of muscle tone (rigidity, hypotonia) and body posture (decerebrate, decorticate, opisthotonic posturing). This observational prospective cohort study will enroll 512 Tanzanian children, 6 months to 6 years old, admitted to the hospital with CM (Group 1) as defined by World Health Organization criteria and uncomplicated malaria (UM-Group 2). Healthy children who are not acutely ill (healthy control, HC-Group 4) and children with coma and/or central nervous system (CNS) illness not attributed to malaria (NMC-Group 3) will serve as controls. Children will be recruited from 2 hospitals in Dar es Salaam, Amana Hospital in the Ilala District (AHID) and Mwananyamala Hospital (MDH)in the Kinondoni District. Children presenting to AHID or MDH, who are diagnosed with CM or a non-malarial CNS condition will be transferred by ambulance to the Clinical Research Unit (CRU) at Hubert Kairuki Memorial University (HKMU). Before transfer the child will be stabilized and treatment will be initiated. A lumbar puncture will be performed. Transfer to the HKMU-CRU will take place only with the parent(s)/guardian(s) permission and the parent(s) and/or guardian(s) will be transferred to HKMU with the child. Comatose children admitted to the hospitals will be evaluated by the house physician and/or member of the study team. Febrile children admitted to the hospital with high level Plasmodium falciparum parasitemia, no other cause of fever identified, nor evidence of severe malaria and no co-infection with other malar
Sponsor: University of Utah

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Information By: University of Utah

Dates:
Date Received: June 15, 2006
Date Started: October 2007
Date Completion:
Last Updated: October 19, 2012
Last Verified: October 2012