Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety of piperacillin-tazobactam in infants < 61 days of age with suspected sepsis. There will be four cohorts of 8 infants each:

1. < 32 weeks gestational age (GA) and < 14 days postnatal age (PNA)

2. < 32 weeks gestational age and >=14 days postnatal age

3. >=32 weeks gestational age and < 14 days postnatal age

4. >=32 weeks gestational age and >=14 days postnatal age. The study requires administration of 6 doses of study drug along with other antimicrobials per standard of care followed by 1 week of safety monitoring. Four 200 µL pK samples will be obtained at steady state. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of broad spectrum 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phillip Brian Smith
• Treatments: Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

Criteria

Inclusion Criteria:

1. Written permission from parent or legal guardian

2. < 61 days of age

3. Likely to survive beyond the first 48 hours after enrollment

4. Sufficient intravascular access (either peripheral or central) to receive study drug.

AND ONE OF THE FOLLOWING

1. Suspected systemic infection

2. Receiving piperacillin-tazobactam as part of standard of care

Exclusion Criteria:

1. History of allergic reactions to any penicillin, cephalosporins, or beta-lactamase inhibitors

2. Urine output < 0.5 mL/hr/kg over the prior 24 hours

3. Serum creatinine > 1.2 mg/dL

4. Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study