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Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections

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ClinicalTrials.gov Identifier: NCT01893346
Recruitment Status : Completed
First Posted : July 9, 2013
Results First Posted : May 27, 2015
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to <18 years.

Condition or disease Intervention/treatment Phase
Systemic Infections Drug: CAZ-AVI Phase 1

Detailed Description:
This is a phase I, open-label, single-dose study. The study aims to characterize the pharmacokinetics of CAZ-AVI and assess its safety and tolerability following a single IV dose given to hospitalized pediatric patients receiving systemic antibiotic therapy for suspected or confirmed infection. This study will include 4 cohorts, each consisting of at least 8 evaluable pediatric patients, aged ≥3 months to <18 years, who are hospitalized with infections.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of Ceftazidime-Avibactam (CAZ-AVI) in Children From 3 Months of Age to <18 Years Who Are Receiving Systemic Antibiotic Therapy for Suspected or Confirmed Infection
Study Start Date : July 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CAZ-AVI
This arm will include 4 cohorts. Patients will be stratified by age.
Drug: CAZ-AVI
Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.




Primary Outcome Measures :
  1. Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: AUC [ Time Frame: Day 1 ]
    Key PK parameters were prespecified to be calculated for cohorts 1 and 2. For cohorts 3 and 4 (where children were <6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.

  2. Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: Cmax [ Time Frame: Day 1 ]
    Key PK parameters are shown for cohorts 1 and 2. For cohorts 3 and 4 (where children were <6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.



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Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent will be obtained from parent(s) or other legally acceptable representative(s), and informed assent from patient (if age appropriate) will be obtained
  2. Male or female children ages ≥3 months to <18 years.
  3. Hospitalized, receiving systemic antibiotic therapy for the treatment of a suspected or confirmed infection, and expected to require hospitalization until after the end of treatment (EOT) evaluations are completed.
  4. If female and has reached menarche, or has reached Tanner stage 3 breast development (even if not having reached menarche), the patient is practicing appropriate birth control or is sexually abstinent.
  5. Likely to survive the current illness or hospitalization.
  6. Sufficient intravascular access (peripheral or central) to receive study drug.

Exclusion Criteria:

  1. History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other β-lactam antibiotics.
  2. If female, currently pregnant or breast feeding or has a positive serum β-human chorionic gonadotropin (β-hCG) pregnancy test.
  3. Receipt of a blood or blood component (e.g., red blood cells, fresh frozen plasma, platelets) transfusion during the 24-hour period before enrolment.
  4. BMI outside the range (below the 5th percentile or above the 85th percentile) for height, age, and weight except for children <2 years of age.
  5. Babies born prior to 37 weeks gestation (cohort 4 only).

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): NCT01893346


Locations
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United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, California
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
United States, Kentucky
Research Site
Louisville, Kentucky, United States
United States, Nebraska
Research Site
Omaha, Nebraska, United States
United States, Ohio
Research Site
Akron, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Toledo, Ohio, United States
United States, Texas
Research Site
Houston, Texas, United States
United States, West Virginia
Research Site
Morgantown, West Virginia, United States
Sponsors and Collaborators
Pfizer
Forest Laboratories
Investigators
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Study Director: Paul Newell, MBBS, MRCP AstraZeneca
Principal Investigator: John Bradley, MD University of California, San Diego

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01893346     History of Changes
Other Study ID Numbers: D4280C00014
First Posted: July 9, 2013    Key Record Dates
Results First Posted: May 27, 2015
Last Update Posted: September 6, 2017
Last Verified: September 2017
Keywords provided by Pfizer:
Ceftazidime, Avibactam, Anti-Infectives
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Ceftazidime
Avibactam
Avibactam, ceftazidime drug combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action