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Efficacy and safety of moxifloxacin vs. ertapenem in complicated intra-abdominal infections: results of the PROMISE study

Abstract number: P1549

De Waele J., Tellado J., Alder J., Reimnitz P., Jensen M., Hampel B., Arvis P.

Introduction: Source control and initiation of optimal antimicrobial therapy are the cornerstones of the management of complicated intra-abdominal infections (cIAIs). Moxifloxacin (MXF) is an important treatment option for cIAI as it has proven clinical efficacy, and activity against the vast majority of causative organisms. The current study was carried out to compare the efficacy and safety of MXF and ertapenem (ERTA) in the treatment of patients with cIAI.

Methods: PROMISE was a prospective, randomised, double-dummy, double-blind, multinational trial in patients with cIAIs. Patients were treated for 5–14 days with MXF, 400 mg IV qd, or ERTA, 1 g IV qd. The primary efficacy variable was clinical response 21–28 days after the end of therapy. Non-inferiority of MXF was demonstrated if the lower limit of the 95% confidence interval (CI) was above -10%.

Results: Of 804 patients randomised (two-thirds from European countries), 798 were valid for the ITT/safety analyses (MXF 408, ERTA 390). Demographics and baseline characteristics were similar in both treatment arms. In the PP population (MXF 352, ERTA 347), the mean (±SD) APACHE II score was 6.8 (±4.4). The mean (±SD) POSSUM (35.1[±7.6]) and Mannheim Peritonitis Index (19.0[±7.2]) scores demonstrate that patients with severe peritonitis were included. The most common cIAI diagnosis was diffuse, secondary peritonitis (MXF 181, ERTA 185). For the primary efficacy variable, MXF was non-inferior to ERTA (Table). This included good efficacy in the more seriously ill patients (APACHE II >10: MXF 55/66, 83.3%; ERTA 53/62, 85.5%; 95% CI -14.8, 10.5), patients with diffuse, secondary peritonitis (MXF 162/181, 89.5%; ERTA 174/185, 94.1%; 95% CI -9.2, 1.9), and patients with non-appendicitis (MXF 160/180, 88.9%; ERTA 157/171, 91.8%; 95% CI -8.8, 3.5). Good bacteriological efficacy was also seen overall (Table) and in patients with polymicrobial infections (MBV population: MXF 212/250, 84.8%; ERTA 205/231, 88.7%). Similar numbers of patients in both arms experienced drug-related treatment-emergent adverse events (ITT/safety population: MXF 77/408, 18.9%; ERTA 74/390, 19.0%).

Conclusions: MXF, the only fluoroquinolone currently marketed for monotherapy of cIAI, was as effective and well tolerated as ERTA. This included good efficacy in the most severely ill patients.

Table 1. Clinical and bacteriological response in the different patient populations of the PROMISE study

PopulationsMXF, n/N (%)ERTA, n/N (%)95% CI
Clinical response
PP315/352 (89.5)324/347 (93.4)-7.9, 0.4
MBV265/297 (89.2)254/276 (92.0)-7.6, 1.9
ITT334/408 (81.9)339/390 (86.9)-9.9, 0.0
ITT with organisms280/340 (82.4)263/308 (85.4)-8.8, 2.2
Bacteriological response
MBV257/297 (86.5)249/276 (90.2)-9.0, 1.5
ITT with organisms271/340 (79.7)258/308 (83.8)-10.0, 1.5
PP: per protocol, MBV: microbiologically valid, ITT: intent-to-treat.

Session Details

Date: 10/04/2010
Time: 00:00-00:00
Session name: Abstracts 20th European Congress of Clinical Microbiology and Infectious Diseases
Subject:
Location: Vienna, Austria, 10 - 13 April 2010
Presentation type:
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