Pharmacokinetics and Safety of Ticarcillin-clavulanate in Infants

Withdrawn before enrolling · Phase 1

Conditions studied: Sepsis

In brief

This study will evaluate the safety, tolerability and PK of ticarcillin-clavulanate in infants \<91 days of age with suspected systemic infection.

Key facts

Study ID

NCT01229046

Run by

Phillip Brian Smith

People needed

0

Starts

2010-09-01

Last updated by the study team

2012-11-14

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written permission from parent or legal guardian
• < 91 days of age
• < 30 weeks gestation at birth
• Likely to survive beyond the first 48 hours after enrollment
• 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

You may not qualify if…

• History of allergic reactions to any penicillin, cephalosporins, or beta-lactamase inhibitors
• Urine output < 0.5 mL/hr/kg over the prior 24 hours
• Serum creatinine > 1.7 mg/dL
• Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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