Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338520
Status:
COMPLETED
Last Update Posted:
2012-10-22
First Post:
2006-06-15
Brief Title:
Hyperphenylalaninemia in Cerebral Malaria
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Hyperphenylalaninemia in Cerebral Malaria
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 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 andor 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 MDHin 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 parentsguardians permission and the parents andor guardians will be transferred to HKMU with the child Comatose children admitted to the hospitals will be evaluated by the house physician andor 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 malaria species will be enrolled in the UM group Health control children will be enrolled from outpatient well-baby clinics at AHID and MDH All ill groups II III IVchildren will have complete blood picture urinalysis blood culture and a blood smear for malaria Lumbar puncture will be performed for diagnosis of meningitis or hemorrhage in groups I and III if there are no contraindications eg papilledema or focal neurological signs suggesting a CNS mass lesion Children will be treated according to Tanzanian standards based on the initial evaluation Those subjects agreeing to enter the study will have portions of the blood urine and CSF preserved for study purposes Study subjects will be followed from the time of hospital admission until death or 1-2 weeks post hospital discharge Primary study objectives are to determine whether African children with cerebral malaria CM have sufficient levels of systemic tetrahydrobiopterin BH4 by analyzing their urine for metabolites of BH4 determine whether these children have sufficient levels of BH4 in their CNS by analyzing their cerebrospinal fluid for BH4 metabolites and determine whether these children have sufficient levels of BH4-dependent biogenic amine neurotransmitters in their CNS by analyzing their cerebrospinal fluid CSF for metabolites of the neurotransmitters Secondary objectives are to determine natural history of hyperphenylalaninemia in CM and correlate with outcome ie death or recovery and determine whether BH4 deficiency is due to low expression of genes encoding de novo BH4 synthesis in peripheral blood mononuclear cells from children with CM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-0116 | None | None | None |