Status:
COMPLETED
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Lead Sponsor:
Phillip Brian Smith
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Sepsis
Prematurity
Eligibility:
All Genders
48-120 years
Phase:
PHASE1
Brief Summary
This is a phase I open label multi-dose study to investigative the pharmacokinetics and safety of cefazolin in infants \<121 days of age and \< 28 weeks gestation with suspected sepsis. There will be ...
Eligibility Criteria
Inclusion
- \< 28 weeks gestation at birth
- \> 48 hours and \<121 days of age at the time of study drug administration
- One of the following:
- Suspected systemic infection
- Receiving cefazolin for prophylaxis
- Receiving cefazolin treatment of a systemic infection
Exclusion
- History of anaphylaxis attributed to a β-lactam
- Exposure to cefazolin in the month prior to study
- Serum creatinine \> 1.7 mg/dL
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00850122
Start Date
July 1 2013
End Date
July 1 2018
Last Update
September 4 2018
Active Locations (1)
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1
Federal University of Sao Paulo
São Paulo, Brazil