先日、ESBLに対して、カルバペネム以外を考える総論を紹介しましたが、
そこで取り上げられていた、Phase3 を振り返りました。
- ASPECT-cIAI
- Ceftazidime-Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-abdominal Infection
- RECAPTURE
ASPECT-cIAI
P : cIAI
E : received either ceftolozane/tazobactam (1.5 g) plus metronidazole (500 mg) every 8 hours intravenously for 4-14 days. n=383
C : meropenem (1 g) every 8 hours intravenously for 4-14 days. n=417
O : Clinical cure rates at the test-of-cure visit (24-32 days from start of therapy) in the microbiological intent-to-treat (primary).
Ceftolozane/tazobactam plus metronidazole was noninferior to meropenem in the primary (83.0% [323/389] vs 87.3% [364/417]; weighted difference, -4.2%; 95% confidence interval [CI], -8.91 to .54).
The frequency of adverse events (AEs) was similar in both treatment groups (44.0% vs 42.7%)
T : randomized, double-blind, phase 3, noninferiority
"Treatment with ceftolozane/tazobactam plus metronidazole was noninferior to meropenem in adult patients with cIAI, including infections caused by multidrug-resistant pathogens."
Ceftazidime-Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-abdominal Infection
P :cIAI
E : Ceftazidime-avibactam plus metronidazole
C : meropenem
O : Clinical cure rates with ceftazidime-avibactam plus metronidazole and meropenem, respectively, were as follows: mMITT population, 81.6% and 85.1% (between-group difference, -3.5%; 95% confidence interval -8.64 to 1.58).
Adverse events were similar between groups.
T : randomized, double-blind, phase 3, noninferiority
"Ceftazidime-avibactam plus metronidazole was noninferior to meropenem in the treatment of complicated intra-abdominal infections. Efficacy was similar against infections caused by ceftazidime-susceptible and ceftazidime-resistant pathogens. The safety profile of ceftazidime-avibactam plus metronidazole was consistent with that previously observed with ceftazidime alone."
RECAPTURE
P : suspected or microbiologically confirmed cUTI/acute pyelonephritis
E : ceftazidime-avibactam
C : doripenem 500 mg every 8 hours (doses adjusted for renal function)
with possible oral antibiotic switch after ≥5 days (total treatment duration up to 10 days or 14 days for patients with bacteremia)
500 mg of Ciprofloxacin (oral) or 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral
O : co-primary endpoints of (1) patient-reported symptomatic resolution at day 5: 276 of 393 (70.2%) vs 276 of 417 (66.2%) patients (difference, 4.0% [95% confidence interval {CI}, -2.39% to 10.42%]); and (2) combined symptomatic resolution/microbiological eradication at test of cure (TOC): 280 of 393 (71.2%) vs 269 of 417 (64.5%) patients (difference, 6.7% [95% CI, .30% to 13.12%]).
Ceftazidime-avibactam had a safety profile consistent with that of ceftazidime alone.
T : randomized, double-blind, phase 3, noninferiority
"Ceftazidime-avibactam was highly effective for the empiric treatment of cUTI (including acute pyelonephritis), and may offer an alternative to carbapenems in this setting."