Prematurity, Sepsis
Conditions
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 two cohorts of 6 infants each: 1) \>48 hours of age and ≤28 days and 2) \>28 days of age and \<121 days of age. The study requires administration of the study drug over 2 days followed by 1 week of safety monitoring. Six 200 µL pK samples will be obtained over the 2 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.
Interventions
DRUGcefazolin
Cefazolin dosing - administered for 48 hours Dosage ≤28 days of age 25 mg/kg IV q12 29-120 days of age 25 mg/kg IV q8
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phillip Brian Smith
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
48 Hours to 120 Days
Healthy volunteers
No
Inclusion criteria
* \< 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 criteria
* History of anaphylaxis attributed to a β-lactam * Exposure to cefazolin in the month prior to study * Serum creatinine \> 1.7 mg/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cefazolin pharmacokinetics including half life, clearance, and volume of distribution | Dose 1 and Dose 4 |
Secondary
| Measure | Time frame |
|---|---|
| Safety | 7 days following last dose of cefazolin |
Countries
Brazil
Outcome results
None listed