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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This study has been withdrawn prior to enrollment.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: 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) ]

    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 ]
    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

  Show Detailed Description


Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Duke University:
presumed sepsis

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Ticarcillin-clavulanic acid
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors processed this record on May 24, 2017