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Metronidazole Pharmacokinetics (PK) in Premature Infants (PTN_METRO)

Primary Purpose

Serious Systemic Infections, Necrotizing Enterocolitis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Metronidazole

About this trial

This is an interventional treatment trial for Serious Systemic Infections focused on measuring Metronidazole, Neonate, Premature, Sepsis, Necrotizing enterocolitis

Eligibility Criteria

undefined - 90 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHOC Children's
Wesely Medical Center
Duke University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Area Under the Curve at Steady State

Area under the curve at steady state (AUCss)

Loading Dose Maximum Concentration

Loading Dose Maximum concentration (Cmax)

Loading Dose Minimum Concentration

Loading Dose Minimum Concentration (mg/L)

Multiple Dose Maximum Concentration

Multiple Dose Maximum Concentration (mg/L)

Multiple Dose Minimum Concentration

Multiple Dose Minimum Concentration (mg/L)

Clearance

Clearance (L/h/kg)

Volume of Distribution

Volume of Distribution (L/kg)

Secondary Outcome Measures

Full Information

NCT ID

NCT01222585

First Posted

October 6, 2010

Last Updated

January 7, 2014

Sponsor

Michael Cohen-Wolkowiez

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01222585

Brief Title

Metronidazole Pharmacokinetics (PK) in Premature Infants

Acronym

PTN_METRO

Official Title

Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael Cohen-Wolkowiez

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Serious Systemic Infections, Necrotizing Enterocolitis

Keywords

Metronidazole, Neonate, Premature, Sepsis, Necrotizing enterocolitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Metronidazole

Other Intervention Name(s)

Flagyl

Intervention Description

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.

Primary Outcome Measure Information:

Title

Area Under the Curve at Steady State

Description

Area under the curve at steady state (AUCss)

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

Title

Loading Dose Maximum Concentration

Description

Loading Dose Maximum concentration (Cmax)

Time Frame