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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This study has been withdrawn prior to enrollment.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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229046
First Posted: October 27, 2010
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center
  Purpose
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
Sepsis Drug: Ticarcillin-clavulanic acid Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetics and Safety of Ticarcillin-clavulanate in Infants

Resource links provided by NLM:


Further study details as provided by Phillip Brian Smith, Duke University Medical Center:

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229046


Locations
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
ClinicalTrials.gov Identifier: NCT01229046     History of Changes
Other Study ID Numbers: Pro00026692
First Submitted: October 14, 2010
First Posted: October 27, 2010
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by Phillip Brian Smith, Duke University Medical Center:
presumed sepsis

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Clavulanic Acid
Ticarcillin-clavulanic acid
Clavulanic Acids
Ticarcillin
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents