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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01229046
First received: October 14, 2010
Last updated: November 12, 2012
Last verified: November 2012
  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: 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 90 Days
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
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:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Ticarcillin
Clavulanic Acids
Clavulanic Acid
Ticarcillin-clavulanic acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014