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

Systemic Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893346
• Other study ID #: D4280C00014
• Status: Completed
• Phase: Phase 1
• First received: June 26, 2013
• Last updated: September 1, 2017
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: September 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 17 Years

Eligibility

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 ß-lactam antibiotics.

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Sepsis
• Systemic Infections

Intervention

Drug:
• CAZ-AVI
Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: AUC	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
Primary	Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: Cmax	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