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• Status: Withdrawn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