CLINICAL DATA THE PHASE 3 REVISIT STUDY

Included 312 hospitalized patients with cIAI1

Class A graphic

ATM-AVI + METRONIDAZOLE

Patients received a loading dose of ATM-AVI* (IV) prior to the maintenance dose of ATM 1.5 g and AVI 0.5 g IV every 6 hours + metronidazole 500 mg IV every 8 hours

n=208

MEROPENEM ± COLISTIN

Meropenem 1 g IV every 8 hours with or without colistin

15 patients (14%) received colistin

n=104

TREATMENT DURATION: 5 TO 14 DAYS
REVISIT STUDY DESIGN1

312

HOSPITALIZED PATIENTS WITH cIAI1

RANDOMIZATION

TOC

TEST OF CURE (TOC) 25 TO 31 DAYS AFTER RANDOMIZATION

 
 
 

*For patients who received EMBLAVEO™, a loading dose was administered and then followed by maintenance doses (based on participant’s creatinine clearance).

OVERVIEW OF cIAI PATIENT POPULATION (ITT)1†

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Aztreonam-avibactam group (n=208)
Meropenem group (n=104)
MEDIAN AGE
53 YEARS
51 YEARS
GENDER
65.4% MALE | 34.6% FEMALE
68% MALE | 32% FEMALE
RACE
52.2% WHITE | 43.6% ASIAN
40% WHITE | 56% ASIAN | 4% OTHER
APACHE SCORE
22% HAD AN APACHE II OF >10 AT BASELINE
23% HAD AN APACHE II SCORE OF >10 AT BASELINE
PRIOR TREATMENT
~11% WERE CLASSIFIED AS PREVIOUS TREATMENT FAILURES
10% WERE CLASSIFIED AS PREVIOUS TREATMENT FAILURES

312 patients with cIAI were randomized in a multinational, multicenter, open-label, central assessor–blinded trial that compared the efficacy of EMBLAVEO + metronidazole vs meropenem ± colistin.1

This study was not powered for comparative inferential efficacy analysis.

  • Efficacy analysis included clinical cure at TOC1

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment no further antimicrobial treatment for the index infection was required and no unplanned drainage or surgical intervention was necessary following the initial procedure.2

APACHE II, Acute Physiology and Chronic Health Evaluation II; ATM, aztreonam; AVI, avibactam; cIAI, complicated intra-abdominal infection; ITT, intent-to-treat.

†Diagnosis of cIAI included patients with appendiceal perforation or periappendiceal abscess, gangrenous cholecystitis with perforation, diverticular disease with perforation or abscess, gastric/duodenal perforation, perforation of the intestine, and other causes of intra-abdominal abscesses and peritonitis.1

Class C graphic

EFFICACY IN PATIENTS WITH cIAI1

Clinical cure rates at TOC, ITT analysis2

ANALYSIS POPULATION
ITT
MICRO-ITT
EMBLAVEO + METRONIDAZOLE
76.4% (n=159/208)
79.9% (n=111/139)
MEROPENEM ± COLISTIN
74.0% (n=77/104)
77.3% (n=58/75)

Per pathogen microbiological response rates for Enterobacterales at TOC (micro-ITT)2‡

ANALYSIS POPULATION
ENTEROBACTERALES
EMBLAVEO + METRONIDAZOLE
81.1% (n=116/143)
MEROPENEM ± COLISTIN
79.7% (n=63/79)

In patients for whom the predominant pathogens were Escherichia coli and Klebsiella pneumoniae, the microbiological response rates at TOC were as follows: E coli, 80.2% (n=89/111) for EMBLAVEO + metronidazole vs 75.9% (n=41/54) for meropenem ± colistin; K pneumoniae, 81.8% (n=9/11) for EMBLAVEO + metronidazole vs 90.9% (n=10/11) for meropenem ± colistin.

Cure rates by resistance type (micro-ITT)2

ANALYSIS POPULATION
ESBL-POSITIVE PATHOGENS
AZTREONAM- NONSUSCEPTIBLE PATHOGENS
EMBLAVEO + METRONIDAZOLE
88.2% (n=15/17)
80.0% (n=16/20)
MEROPENEM ± COLISTIN
76.5% (n=13/17)
72.7% (n=16/22)

Three patients in the EMBLAVEO + metronidazole arm and 4 patients in the meropenem ± colistin arm were infected with pathogens that were not susceptible to meropenem.

ESBL, extended-spectrum β-lactamase.

DATA LIMITATION

This trial was not powered for a comparative inferential efficacy analysis.
 

‡Eradication of baseline causative pathogens in follow-up cultures or achievement of clinical cure at TOC in absence of repeat cultures.

References: 1. Carmeli Y, Cisneros JM, Paul M, et al. Lancet Infect Dis. Published online October 7, 2024. doi:10.1016/S1473-3099(24)00499-7 2. Data on file. AbbVie, Inc.

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