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Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: results of a randomized, double-blind, Phase II trial.
J Antimicrob Chemother. 2013 May; 68(5):1183-92.JA

Abstract

OBJECTIVES

Avibactam, a novel non-β-lactam β-lactamase inhibitor, restores the in vitro activity of ceftazidime against class A, C and some class D β-lactamase-producing pathogens, including those commonly associated with complicated intra-abdominal infections (cIAIs). This randomized, active-controlled, double-blind, Phase II trial (NCT00752219) aimed to evaluate the safety and efficacy of ceftazidime/avibactam plus metronidazole compared with meropenem in hospitalized patients with cIAI.

METHODS

Adults with confirmed cIAI requiring surgical intervention and antibiotics were randomized 1 : 1 to receive intravenously either (i) 2000 mg of ceftazidime plus 500 mg of avibactam plus a separate infusion of 500 mg of metronidazole or (ii) 1000 mg of meropenem plus placebo every 8 h for a minimum of 5 days and a maximum of 14 days. The primary efficacy endpoint was the clinical response in microbiologically evaluable (ME) patients at the test-of-cure (TOC) visit 2 weeks after the last dose of study therapy.

RESULTS

Overall, 101 patients received ceftazidime/avibactam plus metronidazole; 102 received meropenem. The median duration of treatment was 6.0 and 6.5 days, respectively. Favourable clinical response at the TOC visit in the ME population was observed in 91.2% (62/68) and 93.4% (71/76) of patients in the ceftazidime/avibactam plus metronidazole and meropenem groups, respectively (observed difference: -2.2%; 95% CI: -20.4%, 12.2%). The incidence of treatment-emergent adverse events was similar for ceftazidime/avibactam plus metronidazole (64.4%) and meropenem (57.8%).

CONCLUSIONS

Ceftazidime/avibactam plus metronidazole was effective and generally well tolerated in patients with cIAI, with a favourable clinical response rate in the ME population of >90%, similar to that of meropenem.

Authors+Show Affiliations

South Jersey Infectious Diseases, Somers Point, NJ, USA. infect123@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23391714

Citation

Lucasti, Christopher, et al. "Comparative Study of the Efficacy and Safety of Ceftazidime/avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults: Results of a Randomized, Double-blind, Phase II Trial." The Journal of Antimicrobial Chemotherapy, vol. 68, no. 5, 2013, pp. 1183-92.
Lucasti C, Popescu I, Ramesh MK, et al. Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: results of a randomized, double-blind, Phase II trial. J Antimicrob Chemother. 2013;68(5):1183-92.
Lucasti, C., Popescu, I., Ramesh, M. K., Lipka, J., & Sable, C. (2013). Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: results of a randomized, double-blind, Phase II trial. The Journal of Antimicrobial Chemotherapy, 68(5), 1183-92. https://doi.org/10.1093/jac/dks523
Lucasti C, et al. Comparative Study of the Efficacy and Safety of Ceftazidime/avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults: Results of a Randomized, Double-blind, Phase II Trial. J Antimicrob Chemother. 2013;68(5):1183-92. PubMed PMID: 23391714.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: results of a randomized, double-blind, Phase II trial. AU - Lucasti,Christopher, AU - Popescu,Irinel, AU - Ramesh,Mayakonda K, AU - Lipka,Joy, AU - Sable,Carole, Y1 - 2013/02/07/ PY - 2013/2/9/entrez PY - 2013/2/9/pubmed PY - 2013/9/28/medline SP - 1183 EP - 92 JF - The Journal of antimicrobial chemotherapy JO - J Antimicrob Chemother VL - 68 IS - 5 N2 - OBJECTIVES: Avibactam, a novel non-β-lactam β-lactamase inhibitor, restores the in vitro activity of ceftazidime against class A, C and some class D β-lactamase-producing pathogens, including those commonly associated with complicated intra-abdominal infections (cIAIs). This randomized, active-controlled, double-blind, Phase II trial (NCT00752219) aimed to evaluate the safety and efficacy of ceftazidime/avibactam plus metronidazole compared with meropenem in hospitalized patients with cIAI. METHODS: Adults with confirmed cIAI requiring surgical intervention and antibiotics were randomized 1 : 1 to receive intravenously either (i) 2000 mg of ceftazidime plus 500 mg of avibactam plus a separate infusion of 500 mg of metronidazole or (ii) 1000 mg of meropenem plus placebo every 8 h for a minimum of 5 days and a maximum of 14 days. The primary efficacy endpoint was the clinical response in microbiologically evaluable (ME) patients at the test-of-cure (TOC) visit 2 weeks after the last dose of study therapy. RESULTS: Overall, 101 patients received ceftazidime/avibactam plus metronidazole; 102 received meropenem. The median duration of treatment was 6.0 and 6.5 days, respectively. Favourable clinical response at the TOC visit in the ME population was observed in 91.2% (62/68) and 93.4% (71/76) of patients in the ceftazidime/avibactam plus metronidazole and meropenem groups, respectively (observed difference: -2.2%; 95% CI: -20.4%, 12.2%). The incidence of treatment-emergent adverse events was similar for ceftazidime/avibactam plus metronidazole (64.4%) and meropenem (57.8%). CONCLUSIONS: Ceftazidime/avibactam plus metronidazole was effective and generally well tolerated in patients with cIAI, with a favourable clinical response rate in the ME population of >90%, similar to that of meropenem. SN - 1460-2091 UR - https://www.unboundmedicine.com/medline/citation/23391714/Comparative_study_of_the_efficacy_and_safety_of_ceftazidime/avibactam_plus_metronidazole_versus_meropenem_in_the_treatment_of_complicated_intra_abdominal_infections_in_hospitalized_adults:_results_of_a_randomized_double_blind_Phase_II_trial_ L2 - https://academic.oup.com/jac/article-lookup/doi/10.1093/jac/dks523 DB - PRIME DP - Unbound Medicine ER -