Overview

Pharmacokinetics and Safety of Ticarcillin-clavulanate in Infants

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the safety, tolerability and PK of ticarcillin-clavulanate in infants <91 days of age with suspected systemic infection.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Phillip Brian Smith
Treatments:
Clavulanic Acid
Clavulanic Acids
Ticarcillin
Ticarcillin-clavulanic acid
Criteria
Inclusion Criteria:

1. Written permission from parent or legal guardian

2. < 91 days of age

3. < 30 weeks gestation at birth

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

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

AND ONE OF THE FOLLOWING

- Suspected systemic infection

- Receiving ticarcillin-clavulanate 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 > 1.7 mg/dL

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