Metronidazole Pharmacokinetics (PK) in Premature Infants

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Serious Systemic Infections Necrotizing Enterocolitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours

Group Type EXPERIMENTAL

Metronidazole

Intervention Type DRUG

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.

Interventions

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Metronidazole

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.

Intervention Type DRUG

Other Intervention Names

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Flagyl

Eligibility Criteria

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Inclusion Criteria

* Gestational age \<32 weeks at the time of enrollment.
* Postnatal age \<91 days at the time of enrollment.
* Sufficient venous access to permit administration of study medication.
* Infant suspected to have a serious infection and from whom a blood culture has been obtained within 96 hours of study entry.

Exclusion Criteria

* History of anaphylaxis to metronidazole or other nitroimidazole derivatives (e.g., tinidazole).
* Previous exposure to metronidazole in the week prior to study.
* Previous participation in the study.

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No