Status:
COMPLETED
Metronidazole Pharmacokinetics (PK) in Premature Infants
Lead Sponsor:
Michael Cohen-Wolkowiez
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Conditions:
Serious Systemic Infections
Necrotizing Enterocolitis
Eligibility:
All Genders
Up to 90 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01222585
Start Date
January 1 2011
End Date
November 1 2011
Last Update
February 6 2014
Active Locations (3)
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1
CHOC Children's
Orange, California, United States, 92868
2
Wesely Medical Center
Wichita, Kansas, United States, 67214
3
Duke University
Durham, North Carolina, United States, 27715