Metronidazole Pharmacokinetics (PK) in Premature Infants (PTN_METRO)
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|ClinicalTrials.gov Identifier: NCT01222585|
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : December 18, 2013
Last Update Posted : February 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Serious Systemic Infections Necrotizing Enterocolitis||Drug: Metronidazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
Metronidazole will be administered intravenously to premature infants as a 15 mg/kg loading dose followed by maintenance doses of 7.5 mg/kg every 12 hours for infants with >=14 postnatal days and every 24 hours for infants <14 postnatal days.
Other Name: Flagyl
- Area Under the Curve at Steady State [ Time Frame: pre-dose: 30 min; post-dose:10 min, 3-4,6-8, 12-13, 24-25, 36-37, 48-49, 72-73 hours post dose ]Area under the curve at steady state (AUCss)
- Loading Dose Maximum Concentration [ Time Frame: 2-5 days of study drug administration ]Loading Dose Maximum concentration (Cmax)
- Loading Dose Minimum Concentration [ Time Frame: 2-5 days of study drug administration ]Loading Dose Minimum Concentration (mg/L)
- Multiple Dose Maximum Concentration [ Time Frame: 2-5 days of study drug administration ]Multiple Dose Maximum Concentration (mg/L)
- Multiple Dose Minimum Concentration [ Time Frame: 2-5 days of study drug administration ]Multiple Dose Minimum Concentration (mg/L)
- Clearance [ Time Frame: 2-5 days of study drug administration ]Clearance (L/h/kg)
- Volume of Distribution [ Time Frame: 2-5 days of study drug administration ]Volume of Distribution (L/kg)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222585
|United States, California|
|Orange, California, United States, 92868|
|United States, Kansas|
|Wesely Medical Center|
|Wichita, Kansas, United States, 67214|
|United States, North Carolina|
|Durham, North Carolina, United States, 27715|
|Principal Investigator:||Michael Cohen-wolkowiez, MD||Duke University|