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

Last updated on November 21, 2019

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Study Location
Research Site
Little Rock, Arkansas, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-17 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin,
other ?-lactam antibiotics.

2. If female, currently pregnant or breast feeding or has a positive serum ?-human
chorionic gonadotropin (?-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

5. Babies born prior to 37 weeks gestation (cohort 4 only).

NCT01893346
Pfizer
Completed
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections

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Descriptive Information
Brief Title  ICMJE Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections
Official Title  ICMJE 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
Brief SummaryTo assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to <18 years.
Detailed DescriptionThis 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Systemic Infections
Intervention  ICMJE Drug: CAZ-AVI
Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.
Study Arms  ICMJE Experimental: CAZ-AVI
This arm will include 4 cohorts. Patients will be stratified by age.
Intervention: Drug: CAZ-AVI
Publications *Bradley JS, Armstrong J, Arrieta A, Bishai R, Das S, Delair S, Edeki T, Holmes WC, Li J, Moffett KS, Mukundan D, Perez N, Romero JR, Speicher D, Sullivan JE, Zhou D. Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6252-9. doi: 10.1128/AAC.00862-16. Print 2016 Oct.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2015)
35
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2013)
40
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion DateOctober 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ?-lactam antibiotics.
  2. If female, currently pregnant or breast feeding or has a positive serum ?-human chorionic gonadotropin (?-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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 3 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893346
Other Study ID Numbers  ICMJE D4280C00014
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Study Director:Paul Newell, MBBS, MRCPAstraZeneca
Principal Investigator:John Bradley, MDUniversity of California, San Diego
PRS AccountPfizer
Verification DateSeptember 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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