Metronidazole Pharmacokinetics (PK) in Premature Infants (PTN_METRO)
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Serious Systemic Infections Necrotizing Enterocolitis | Drug: Metronidazole | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants |
- 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)
- Loading Dose Maximum Concentration [ Time Frame: 2-5 days of study drug administration ]Loading Dose Maximum concentration (Cmax)
- Loading Dose Minimum Concentration [ Time Frame: 2-5 days of study drug administration ]Loading Dose Minimum Concentration (mg/L)
- Multiple Dose Maximum Concentration [ Time Frame: 2-5 days of study drug administration ]Multiple Dose Maximum Concentration (mg/L)
- Multiple Dose Minimum Concentration [ Time Frame: 2-5 days of study drug administration ]Multiple Dose Minimum Concentration (mg/L)
- Clearance [ Time Frame: 2-5 days of study drug administration ]Clearance (L/h/kg)
- Volume of Distribution [ Time Frame: 2-5 days of study drug administration ]Volume of Distribution (L/kg)
| Enrollment: | 24 |
| Study Start Date: | January 2011 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility
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| Ages Eligible for Study: | up to 90 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| 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 | |
| Principal Investigator: | Michael Cohen-wolkowiez, MD | Duke University |
More Information
Publications:
| Responsible Party: | Michael Cohen-Wolkowiez, Assistant Professor of Pediatrics, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01222585 History of Changes |
| Other Study ID Numbers: |
Pro00024571 HHSN27500003I ( Other Grant/Funding Number: NICHD ) |
| First Submitted: | October 6, 2010 |
| First Posted: | October 18, 2010 |
| Results First Submitted: | July 23, 2013 |
| Results First Posted: | December 18, 2013 |
| Last Update Posted: | February 6, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Michael Cohen-Wolkowiez, Duke University Medical Center:
|
Metronidazole Neonate Premature Sepsis Necrotizing enterocolitis |
Additional relevant MeSH terms:
|
Premature Birth Enterocolitis Enterocolitis, Necrotizing Sepsis 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 Antiprotozoal Agents Antiparasitic Agents |