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

September 1, 2017 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Orange, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Research Site
    • Ohio
      • Akron, Ohio, United States
        • Research Site
      • Cleveland, Ohio, United States
        • Research Site
      • Toledo, Ohio, United States
        • Research Site
    • Texas
      • Houston, Texas, United States
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Forest Laboratories

Investigators

  • Principal Investigator: John Bradley, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (ESTIMATE)

July 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4280C00014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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