Status:
COMPLETED
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Forest Laboratories
Conditions:
Systemic Infections
Eligibility:
All Genders
3-17 years
Phase:
PHASE1
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01893346
Start Date
July 1 2013
End Date
October 1 2014
Last Update
September 6 2017
Active Locations (10)
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1
Research Site
Little Rock, Arkansas, United States
2
Research Site
Orange, California, United States
3
Research Site
San Diego, California, United States
4
Research Site
Louisville, Kentucky, United States