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Moxifloxacin is non-inferior to combination therapy with ceftriaxone plus metronidazole in patients with community-origin complicated intra-abdominal infections.
Int J Antimicrob Agents. 2009 Nov; 34(5):439-45.IJ

Abstract

Management of community-origin complicated intra-abdominal infections (cIAIs) requires surgical intervention and antimicrobial therapy. This multinational, randomised, double-blind clinical trial carried out in Asia compared the efficacy and safety of moxifloxacin monotherapy and ceftriaxone/metronidazole combination therapy in adults with confirmed or suspected cIAI. Patients received surgical intervention and either intravenous (i.v.) moxifloxacin 400 mg once daily or i.v. ceftriaxone 2 g once daily plus i.v. metronidazole 500 mg twice daily. A total of 364 patients were randomised [intent-to-treat (ITT), moxifloxacin N=180, comparator N=181; per-protocol (PP), moxifloxacin N=174, comparator N=171]. The most common cIAI diagnosis was complicated appendicitis. Moxifloxacin was non-inferior to ceftriaxone/metronidazole in terms of clinical response at test-of-cure in the PP population [clinical cure, 90.2% for moxifloxacin vs. 96.5% for ceftriaxone/metronidazole; 95% confidence interval (CI) of the difference -11.7 to -1.7] and in the ITT population (87.2% for moxifloxacin vs. 91.2% for ceftriaxone/metronidazole; 95% CI -10.7 to 1.9). Bacteriological cure rates in the microbiologically evaluable population support the clinical results (89.4% for moxifloxacin vs. 95.9% for ceftriaxone/metronidazole; 95% CI -13.3 to -0.6). The incidence of treatment-emergent adverse events was similar for both treatment groups (moxifloxacin 31.7% vs. comparator 24.3%). These results confirm previous findings that moxifloxacin plus adequate source control is an appropriate treatment of cIAI.

Authors+Show Affiliations

Division of Trauma/Critical Care, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH 45267-0558, USA. joseph.solomkin@uc.eduNo 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

19692210

Citation

Solomkin, Joseph, et al. "Moxifloxacin Is Non-inferior to Combination Therapy With Ceftriaxone Plus Metronidazole in Patients With Community-origin Complicated Intra-abdominal Infections." International Journal of Antimicrobial Agents, vol. 34, no. 5, 2009, pp. 439-45.
Solomkin J, Zhao YP, Ma EL, et al. Moxifloxacin is non-inferior to combination therapy with ceftriaxone plus metronidazole in patients with community-origin complicated intra-abdominal infections. Int J Antimicrob Agents. 2009;34(5):439-45.
Solomkin, J., Zhao, Y. P., Ma, E. L., Chen, M. J., & Hampel, B. (2009). Moxifloxacin is non-inferior to combination therapy with ceftriaxone plus metronidazole in patients with community-origin complicated intra-abdominal infections. International Journal of Antimicrobial Agents, 34(5), 439-45. https://doi.org/10.1016/j.ijantimicag.2009.06.022
Solomkin J, et al. Moxifloxacin Is Non-inferior to Combination Therapy With Ceftriaxone Plus Metronidazole in Patients With Community-origin Complicated Intra-abdominal Infections. Int J Antimicrob Agents. 2009;34(5):439-45. PubMed PMID: 19692210.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Moxifloxacin is non-inferior to combination therapy with ceftriaxone plus metronidazole in patients with community-origin complicated intra-abdominal infections. AU - Solomkin,Joseph, AU - Zhao,Yu-Pei, AU - Ma,En-Ling, AU - Chen,Min-Jun, AU - Hampel,Barbara, AU - ,, Y1 - 2009/08/18/ PY - 2009/03/26/received PY - 2009/06/23/revised PY - 2009/06/26/accepted PY - 2009/8/21/entrez PY - 2009/8/21/pubmed PY - 2009/11/7/medline SP - 439 EP - 45 JF - International journal of antimicrobial agents JO - Int. J. Antimicrob. Agents VL - 34 IS - 5 N2 - Management of community-origin complicated intra-abdominal infections (cIAIs) requires surgical intervention and antimicrobial therapy. This multinational, randomised, double-blind clinical trial carried out in Asia compared the efficacy and safety of moxifloxacin monotherapy and ceftriaxone/metronidazole combination therapy in adults with confirmed or suspected cIAI. Patients received surgical intervention and either intravenous (i.v.) moxifloxacin 400 mg once daily or i.v. ceftriaxone 2 g once daily plus i.v. metronidazole 500 mg twice daily. A total of 364 patients were randomised [intent-to-treat (ITT), moxifloxacin N=180, comparator N=181; per-protocol (PP), moxifloxacin N=174, comparator N=171]. The most common cIAI diagnosis was complicated appendicitis. Moxifloxacin was non-inferior to ceftriaxone/metronidazole in terms of clinical response at test-of-cure in the PP population [clinical cure, 90.2% for moxifloxacin vs. 96.5% for ceftriaxone/metronidazole; 95% confidence interval (CI) of the difference -11.7 to -1.7] and in the ITT population (87.2% for moxifloxacin vs. 91.2% for ceftriaxone/metronidazole; 95% CI -10.7 to 1.9). Bacteriological cure rates in the microbiologically evaluable population support the clinical results (89.4% for moxifloxacin vs. 95.9% for ceftriaxone/metronidazole; 95% CI -13.3 to -0.6). The incidence of treatment-emergent adverse events was similar for both treatment groups (moxifloxacin 31.7% vs. comparator 24.3%). These results confirm previous findings that moxifloxacin plus adequate source control is an appropriate treatment of cIAI. SN - 1872-7913 UR - https://www.unboundmedicine.com/medline/citation/19692210/Moxifloxacin_is_non_inferior_to_combination_therapy_with_ceftriaxone_plus_metronidazole_in_patients_with_community_origin_complicated_intra_abdominal_infections_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0924-8579(09)00336-7 DB - PRIME DP - Unbound Medicine ER -