Status:
WITHDRAWN
Pharmacokinetics and Safety of Ticarcillin-clavulanate in Infants
Lead Sponsor:
Phillip Brian Smith
Conditions:
Sepsis
Eligibility:
All Genders
Up to 90 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, tolerability and PK of ticarcillin-clavulanate in infants \<91 days of age with suspected systemic infection.
Detailed Description
4.3 Procedures by Visit 4.3.1 Pre-Study Drug Administration Procedures (Study Day 0) The following procedures will be completed prior to the administration of study drug: 1. Obtain signed and dated...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01229046
Start Date
September 1 2010
Last Update
November 14 2012
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029