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Completed

NCT Number: NCT01222585

Metronidazole Pharmacokinetics (PK) 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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Key information

Conditions

Serious Systemic Infections Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Infections Inflammation Intestinal Diseases Necrotizing Enterocolitis Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

Up to 90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHOC Children's, Orange, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metronidazole

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.

Other names: Flagyl

Primary outcomes

  1. 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)

  2. Loading Dose Maximum Concentration

    Time frame: 2-5 days of study drug administration

    Loading Dose Maximum concentration (Cmax)

  3. Loading Dose Minimum Concentration

    Time frame: 2-5 days of study drug administration

    Loading Dose Minimum Concentration (mg/L)

  4. Multiple Dose Maximum Concentration

    Time frame: 2-5 days of study drug administration

    Multiple Dose Maximum Concentration (mg/L)

  5. Multiple Dose Minimum Concentration

    Time frame: 2-5 days of study drug administration

    Multiple Dose Minimum Concentration (mg/L)

  6. Clearance

    Time frame: 2-5 days of study drug administration

    Clearance (L/h/kg)

  7. Volume of Distribution

    Time frame: 2-5 days of study drug administration

    Volume of Distribution (L/kg)

Sponsors and collaborators

Lead sponsor

Michael Cohen-Wolkowiez

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • The Emmes Company, LLC

Registry information

Official study title

Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants

Acronym: PTN_METRO

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 18, 2010
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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