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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Systemic Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CAZ-AVI

This arm will include 4 cohorts. Patients will be stratified by age.

Group Type EXPERIMENTAL

CAZ-AVI

Intervention Type DRUG

Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.

Interventions

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CAZ-AVI

Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No