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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Systemic Infections

Treatments

Drug: CAZ-AVI

Study type

Interventional

Funder types

Industry

Identifiers

NCT01893346
D4280C00014

Details and patient eligibility

About

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

Full 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.

Enrollment

35 patients

Sex

All

Ages

3 months to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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
  • Male or female children ages ≥3 months to <18 years.
  • 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.
  • 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.
  • Likely to survive the current illness or hospitalization.
  • Sufficient intravascular access (peripheral or central) to receive study drug.

Exclusion criteria

  • History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other β-lactam antibiotics.
  • If female, currently pregnant or breast feeding or has a positive serum β-human chorionic gonadotropin (β-hCG) pregnancy test.
  • Receipt of a blood or blood component (e.g., red blood cells, fresh frozen plasma, platelets) transfusion during the 24-hour period before enrolment.
  • 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.
  • Babies born prior to 37 weeks gestation (cohort 4 only).

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

CAZ-AVI
Experimental group
Description:
This arm will include 4 cohorts. Patients will be stratified by age.
Treatment:
Drug: CAZ-AVI

Trial contacts and locations

10

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems