cIAI Pediatric Trial—ANDI
cIAI pediatric trial vs meropenem
STUDY DESIGN1
TYPE OF TRIAL
Multicenter, single-blind, randomized, actively-controlled trial
STUDY POPULATION
83 hospitalized pediatric patients aged 3 months to less than 18 years of age with cIAI
The median age in the AVYCAZ group was 11.0 years.
The intent-to-treat (ITT) included 83 patients who were randomized to receive treatment (AVYCAZ plus metronidazole, n=61; meropenem, n=22).
The microbiological intent-to treat (micro-ITT) population, which included all patients who had at least one baseline intra-abdominal pathogen, consisted of 69 patients (AVYCAZ plus metronidazole, n=50; meropenem, n=19).
COMPARATIVE AGENTS
AVYCAZ 62.5 mg/kg (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg) IV every 8 hours for 2 hours in patients 2 years to <18 years with a maximum dose of ceftazidime 2 grams and avibactam 0.5 grams + metronidazole (10 mg/kg IV over 20-30 min every 8 hours)
AVYCAZ 62.5 mg/kg (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg) IV every 8 hours for 2 hours in patients 6 months to <2 years + metronidazole (10 mg/kg IV over 20-30 min every 8 hours)
AVYCAZ 50 mg/kg (ceftazidime 40 mg/kg and avibactam 10 mg/kg) IV every 8 hours for 2 hours in patients 3 months to <6 months of age + metronidazole (10 mg/kg IV over 20-30 min every 8 hours)
Meropenem (20 mg/kg IV every 8 hours)
Patients received IV treatment for a minimum of 72 hours before an optional switch to oral therapy at the discretion of the investigator
TREATMENT DURATION
7 to 15 days (IV drug and oral switch treatment)
PRIMARY ENDPOINTS
The primary objective of the study was to evaluate the safety and tolerability of AVYCAZ, and it was not powered for a statistical analysis of efficacy.
Favorable clinical response at TOC was defined as resolution of all acute signs and symptoms of cIAI or improvement to such an extent that no further antimicrobial therapy was required. TOC assessment was performed 8 to 15 days after the last dose of any study drug (IV or oral).
IV, intravenous.
micro-ITT, microbiological intent-to-treat.
TOC, test of cure.
Clinical response in pediatric cIAI demonstrated vs meropenem1
CLINICAL CURE RATES AT TOC (ITT and micro-ITT)
The primary objective of the study was to evaluate the safety and tolerability of AVYCAZ, and it was not powered for a statistical analysis of efficacy.
Clinical cure rates at the TOC visit by baseline pathogen (micro-ITT)
E. coli (79.7%) and P. aeruginosa (33.3%) were the predominant baseline pathogens
- Clinical cure rates in patients infected with E. coli were 90.5% in those treated with AVYCAZ plus metronidazole and 92.3% in those treated with meropenem
- Clinical cure rates in patients infected with P. aeruginosa were 85.7% in those treated with AVYCAZ plus metronidazole and 88.9% in those treated with meropenem
ITT, intent-to-treat.
The use of AVYCAZ in pediatric patients 3 months of age and older in the treatment of cIAI is also supported by evidence from adequate and well-controlled studies of AVYCAZ in adults with cIAI along with additional pharmacokinetic and safety data from pediatric trials.