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

Completed · Phase 1

Conditions studied: Systemic Infections

In brief

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

Key facts

Study ID

NCT01893346

Run by

Pfizer

People needed

35

Starts

2013-07-01

Expected to finish

2014-10-01

Last updated by the study team

2017-09-06

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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