Pharmacokinetics and Safety of Ticarcillin-clavulanate in Infants

This study has been withdrawn prior to enrollment.
(No enrollment occured. Subjects will be enrolled under a new protocol.)
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center Identifier:
First received: October 14, 2010
Last updated: November 12, 2012
Last verified: November 2012

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

Condition Intervention Phase
Drug: Ticarcillin-clavulanic acid
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacokinetics and Safety of Ticarcillin-clavulanate in Infants

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Clearance of ticarcillin-clavulanate [ Time Frame: steady state samples will be drawn on day 2-3 of study drug therapy (around dose 4, 5, or 6) ] [ Designated as safety issue: No ]

    The following PK parameters will be estimated:

    1. Systemic clearance
    2. Volume of distribution
    3. Cmax, Tmax, AUC0-Τ, (at steady state), Ke and t1/2
    4. CSF/plasma ticarcillin-clavulanate concentration ratio
    5. Urine/plasma ticarcillin-clavulanate concentration ratio

Secondary Outcome Measures:
  • Incidence of adverse events as a measure of safety and tolerability [ Time Frame: 1st dose to 7 days after the last dose ] [ Designated as safety issue: Yes ]
    all serious adverse events and adverse events (definitely and probably related to study drug) will be recorded

Enrollment: 0
Study Start Date: September 2010
Arms Assigned Interventions
Active Comparator: ticarcillin-clavulanate
5 doses of IV ticarcillin-clavulanate infants < 14 days PNA will receive 75 mg/kg Q12 infants ≥ 14 days PNA will receive 75 mg/kg Q8
Drug: Ticarcillin-clavulanic acid
5 doses of IV ticarcillin-clavulanate infants < 14 days PNA will receive 75 mg/kg Q12 infants ≥ 14 days PNA will receive 75 mg/kg Q8

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Ages Eligible for Study:   up to 90 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.


  • 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
  Contacts and Locations
Please refer to this study by its identifier: NCT01229046

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Phillip Brian Smith
  More Information

No publications provided

Responsible Party: Phillip Brian Smith, Associate Professor of Pediatrics, Duke University Medical Center Identifier: NCT01229046     History of Changes
Other Study ID Numbers: Pro00026692
Study First Received: October 14, 2010
Last Updated: November 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
presumed sepsis

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Clavulanic Acids
Clavulanic Acid
Ticarcillin-clavulanic acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 15, 2014