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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01222585
Other study ID # Pro00024571
Secondary ID HHSN27500003I
Status Completed
Phase Phase 1
First received October 6, 2010
Last updated January 7, 2014
Start date January 2011
Est. completion date November 2011

Study information

Verified date January 2014
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 90 Days
Eligibility 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.

Study Design

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


Intervention

Drug:
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.

Locations

Country Name City State
United States Duke University Durham North Carolina
United States CHOC Children's Orange California
United States Wesely Medical Center Wichita Kansas

Sponsors (3)

Lead Sponsor Collaborator
Michael Cohen-Wolkowiez Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The EMMES Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cohen-Wolkowiez M, Sampson M, Bloom BT, Arrieta A, Wynn JL, Martz K, Harper B, Kearns GL, Capparelli EV, Siegel D, Benjamin DK Jr, Smith PB; Best Pharmaceuticals for Children Act–Pediatric Trials Network. Determining population and developmental pharmacok — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Curve at Steady State Area under the curve at steady state (AUCss) 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 Yes
Primary Loading Dose Maximum Concentration Loading Dose Maximum concentration (Cmax) 2-5 days of study drug administration Yes
Primary Loading Dose Minimum Concentration Loading Dose Minimum Concentration (mg/L) 2-5 days of study drug administration Yes
Primary Multiple Dose Maximum Concentration Multiple Dose Maximum Concentration (mg/L) 2-5 days of study drug administration Yes
Primary Multiple Dose Minimum Concentration Multiple Dose Minimum Concentration (mg/L) 2-5 days of study drug administration Yes
Primary Clearance Clearance (L/h/kg) 2-5 days of study drug administration Yes
Primary Volume of Distribution Volume of Distribution (L/kg) 2-5 days of study drug administration Yes
See also
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Completed NCT01735578 - Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis N/A