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Metronidazole Pharmacokinetics (PK) in Premature Infants (PTN_METRO)

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ClinicalTrials.gov Identifier: NCT01222585
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : December 18, 2013
Last Update Posted : February 6, 2014
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Information provided by (Responsible Party):
Michael Cohen-Wolkowiez, Duke University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Serious Systemic Infections Necrotizing Enterocolitis Drug: Metronidazole Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants
Study Start Date : January 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
 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.
Other Name: Flagyl


Outcome Measures
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Primary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222585


Locations
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United States, California
CHOC Children's
Orange, California, United States, 92868
United States, Kansas
Wesely Medical Center
Wichita, Kansas, United States, 67214
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27715
Sponsors and Collaborators
Michael Cohen-Wolkowiez
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Investigators
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Principal Investigator: Michael Cohen-wolkowiez, MD Duke University
More Information
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Publications of Results:

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Responsible Party: Michael Cohen-Wolkowiez, Assistant Professor of Pediatrics, Duke University
ClinicalTrials.gov Identifier: NCT01222585    
Other Study ID Numbers: Pro00024571
HHSN27500003I ( Other Grant/Funding Number: NICHD )
First Posted: October 18, 2010    Key Record Dates
Results First Posted: December 18, 2013
Last Update Posted: February 6, 2014
Last Verified: January 2014
Keywords provided by Michael Cohen-Wolkowiez, Duke University:
Metronidazole
Neonate
Premature
Sepsis
Necrotizing enterocolitis
Additional relevant MeSH terms:
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Sepsis
Enterocolitis
Enterocolitis, Necrotizing
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents