Metronidazole Pharmacokinetics (PK) in Premature Infants



Status:Archived
Conditions:Colitis, Hospital, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:December 2010
End Date:March 2012

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Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants


Yearly in the United States over 500,000 newborns are delivered prematurely. This population
is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants
with necrotizing enterocolitis are at high risk of death, and survivors are at increased
risk of mental retardation. Metronidazole is an antibiotic that is often administered to
infants with suspected or confirmed necrotizing enterocolitis. Unfortunately, the
appropriate dose of metronidazole in premature infants has not been established and it is
likely to be different from older children and adults.

The investigators will investigate the appropriate metronidazole dose in very premature
infants by: 1) determining how premature infants eliminate metronidazole from the body and
2) determining the safest and most effective dose of metronidazole in premature infants.

The investigators hypothesis are: 1) The rate of removal of metronidazole will increase with
infant maturity and 2) an appropriate metronidazole dosing regimen will result in necessary
drug levels to treat bacteria involved in necrotizing enterocolitis.



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Durham, North Carolina 27710
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