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Metronidazole Pharmacokinetics (PK) in Premature Infants

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Serious Systemic Infections; Necrotizing Enterocolitis

Intervention: Metronidazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Michael Cohen-Wolkowiez

Official(s) and/or principal investigator(s):
Michael Cohen-wolkowiez, MD, Principal Investigator, Affiliation: Duke University

Summary

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.

Clinical Details

Official title: Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Area Under the Curve at Steady State

Loading Dose Maximum Concentration

Loading Dose Minimum Concentration

Multiple Dose Maximum Concentration

Multiple Dose Minimum Concentration

Clearance

Volume of Distribution

Eligibility

Minimum age: N/A. Maximum age: 90 Days. Gender(s): Both.

Criteria:

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.

Locations and Contacts

CHOC Children's, Orange, California 92868, United States

Wesely Medical Center, Wichita, Kansas 67214, United States

Duke University, Durham, North Carolina 27715, United States

Additional Information

Starting date: January 2011
Last updated: January 7, 2014

Page last updated: August 23, 2015

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