At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
CAZ-AVIdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating CAZ-AVI for Systemic Infections. Completed, enrolled 35 participants across 10 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Infections
CountriesUnited States
CollaboratorsForest Laboratories
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedJul 2013
Primary CompletionOct 2014
TodayJul 2026
First PostedJul 9, 2013
Enrollment StartJul 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.0 years ago
Interventions
CAZ-AVIdrug
Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.