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Randomised clinical trial of moxifloxacin versus ertapenem in complicated intra-abdominal infections: results of the PROMISE study.
Int J Antimicrob Agents. 2013 Jan; 41(1):57-64.IJ

Abstract

Antibiotic therapy for complicated intra-abdominal infections (cIAIs) should provide broad-spectrum coverage both Gram-positive and Gram-negative microorganisms. The PROMISE study compared the clinical and bacteriological efficacy and safety of moxifloxacin versus ertapenem for the treatment of cIAIs. This randomised, prospective, double-dummy, double-blind, multicentre trial was designed as a non-inferiority study. The safety and efficacy of 5-14 days of daily intravenous moxifloxacin (400mg) or ertapenem (1g) were compared in patients with cIAIs requiring surgery and parenteral antibiotic therapy. The primary and secondary endpoints included clinical and bacteriological responses at 21-28 days after the end of treatment (TOC), respectively. Of 830 enrolled patients, 699 were efficacy valid. Moxifloxacin was non-inferior to ertapenem regarding clinical success [89.5% (315/352) versus 93.4% (324/347); 95% confidence interval (CI) -7.9%, 0.4%]. There were no significant differences between groups for any of the primary causes or types of cIAI regarding clinical response. Bacteriological success was achieved in 86.5% (257/297) of moxifloxacin-treated patients and 90.2% (249/276) of ertapenem-treated patients (95% CI -9.0%, 1.5%). There were no major differences between groups regarding the frequency or types of organisms eradicated. The incidence of adverse events (AEs) was higher with moxifloxacin than ertapenem (P=0.039), however a similar number of drug-related AEs was seen in each group (P=1.000). Wound infections, nausea and increased lipase were the most commonly reported AEs with both agents. The results show that moxifloxacin is a valuable treatment option for a range of community-acquired cIAIs with mild-to-moderate severity.

Authors+Show Affiliations

Department of Critical Care Medicine, Ghent University Hospital, Ghent, Belgium. Jan.DeWaele@UGent.beNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23153963

Citation

De Waele, J J., et al. "Randomised Clinical Trial of Moxifloxacin Versus Ertapenem in Complicated Intra-abdominal Infections: Results of the PROMISE Study." International Journal of Antimicrobial Agents, vol. 41, no. 1, 2013, pp. 57-64.
De Waele JJ, Tellado JM, Alder J, et al. Randomised clinical trial of moxifloxacin versus ertapenem in complicated intra-abdominal infections: results of the PROMISE study. Int J Antimicrob Agents. 2013;41(1):57-64.
De Waele, J. J., Tellado, J. M., Alder, J., Reimnitz, P., Jensen, M., Hampel, B., & Arvis, P. (2013). Randomised clinical trial of moxifloxacin versus ertapenem in complicated intra-abdominal infections: results of the PROMISE study. International Journal of Antimicrobial Agents, 41(1), 57-64. https://doi.org/10.1016/j.ijantimicag.2012.08.013
De Waele JJ, et al. Randomised Clinical Trial of Moxifloxacin Versus Ertapenem in Complicated Intra-abdominal Infections: Results of the PROMISE Study. Int J Antimicrob Agents. 2013;41(1):57-64. PubMed PMID: 23153963.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised clinical trial of moxifloxacin versus ertapenem in complicated intra-abdominal infections: results of the PROMISE study. AU - De Waele,J J, AU - Tellado,J M, AU - Alder,J, AU - Reimnitz,P, AU - Jensen,M, AU - Hampel,B, AU - Arvis,P, Y1 - 2012/11/13/ PY - 2011/11/22/received PY - 2012/08/15/revised PY - 2012/08/15/accepted PY - 2012/11/17/entrez PY - 2012/11/17/pubmed PY - 2013/5/29/medline SP - 57 EP - 64 JF - International journal of antimicrobial agents JO - Int J Antimicrob Agents VL - 41 IS - 1 N2 - Antibiotic therapy for complicated intra-abdominal infections (cIAIs) should provide broad-spectrum coverage both Gram-positive and Gram-negative microorganisms. The PROMISE study compared the clinical and bacteriological efficacy and safety of moxifloxacin versus ertapenem for the treatment of cIAIs. This randomised, prospective, double-dummy, double-blind, multicentre trial was designed as a non-inferiority study. The safety and efficacy of 5-14 days of daily intravenous moxifloxacin (400mg) or ertapenem (1g) were compared in patients with cIAIs requiring surgery and parenteral antibiotic therapy. The primary and secondary endpoints included clinical and bacteriological responses at 21-28 days after the end of treatment (TOC), respectively. Of 830 enrolled patients, 699 were efficacy valid. Moxifloxacin was non-inferior to ertapenem regarding clinical success [89.5% (315/352) versus 93.4% (324/347); 95% confidence interval (CI) -7.9%, 0.4%]. There were no significant differences between groups for any of the primary causes or types of cIAI regarding clinical response. Bacteriological success was achieved in 86.5% (257/297) of moxifloxacin-treated patients and 90.2% (249/276) of ertapenem-treated patients (95% CI -9.0%, 1.5%). There were no major differences between groups regarding the frequency or types of organisms eradicated. The incidence of adverse events (AEs) was higher with moxifloxacin than ertapenem (P=0.039), however a similar number of drug-related AEs was seen in each group (P=1.000). Wound infections, nausea and increased lipase were the most commonly reported AEs with both agents. The results show that moxifloxacin is a valuable treatment option for a range of community-acquired cIAIs with mild-to-moderate severity. SN - 1872-7913 UR - https://www.unboundmedicine.com/medline/citation/23153963/Randomised_clinical_trial_of_moxifloxacin_versus_ertapenem_in_complicated_intra_abdominal_infections:_results_of_the_PROMISE_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0924-8579(12)00350-0 DB - PRIME DP - Unbound Medicine ER -