Efficacy and Safety of Ertapenem Versus Piperacillin-Tazobactam for the Treatment of Intra-Abdominal Infections Requiring Surgical Intervention

Peña, Alfredo; Asperger, Walter; Köckerling, F.; Raz, Raul; Kafka, Reinhold; Warren, Brian; Shivaprakash, Malathi; Giezek, Hilde; DiNubile, Mark J.; Chan, Christina Y.

doi:10.1016/j.gassur.2005.06.015

Cited by 40 publications

(42 citation statements)

References 28 publications

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“…[17][18][19] The clinical outcome of evaluable patients was classified into three groups: cure (no signs or symptoms of infection and no further antimicrobial therapy), failure (no improvement, infection progression, or death caused by infection), or late failure (recurrence between cessation of antibiotics and follow-up).…”

Section: Clinical and Laboratory Assessmentsmentioning

confidence: 99%

“…1,3,5,16,17 In three earlier double-blind, randomized clinical trials, a standard duration therapy with ertapenem was comparably effective and as well tolerated as a standard duration therapy with piperacillintazobactam and ceftriaxone plus metronidazole. [17][18][19] Demonstrating that short course of ertapenem is an effective monotherapy for community acquired intraabdominal infection is particularly important in the context of resistance and of cost.…”

Section: Introductionmentioning

confidence: 99%

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A Prospective, Double-Blind, Multicenter, Randomized Trial Comparing Ertapenem 3 Vs ≥5 Days in Community-Acquired Intraabdominal Infection

Basoli

Chirletti

Cirino

et al. 2008

Journal of Gastrointestinal Surgery

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Severe secondary peritonitis is diagnosed in only 20-30% of all patients, but studies to date have persisted in using a standard fixed duration of antibiotic therapy. This prospective, double-blind, multicenter, randomized clinical study compared the clinical and bacteriological efficacy and tolerability of ertapenem (1 g/day) 3 days (group I) vs >or=5 days (group II) in 111 patients with localized peritonitis (appendicitis vs non-appendicitis) of mild to moderate severity, requiring surgical intervention. In evaluable patients, the clinical response as primary efficacy outcome were assessed at the test-of-cure 2 and 4 weeks after discontinuation of antibacterial therapy. Ninety patients were evaluable. In groups I and II, 92.9 and 89.6% of patients were cured, respectively; 95.3% in group I and 93.7% in group II showed eradication. These differences were not statistically significant. The most frequent bacteria recovered were Escherichia coli and Bacteroides fragilis. A wound infection developed in seven patients (7.7%) and an intraabdominal infection in one patient (1.1%). There was a low frequency of drug-related clinical or laboratory adverse effects in both groups. Our study demonstrated that, in patients with localized community-acquired intraabdominal infection, a 3-day course of ertapenem had the same clinical and bacteriological efficacy as a standard duration.

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Section: Clinical and Laboratory Assessmentsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Prospective, Double-Blind, Multicenter, Randomized Trial Comparing Ertapenem 3 Vs ≥5 Days in Community-Acquired Intraabdominal Infection

Basoli

Chirletti

Cirino

et al. 2008

Journal of Gastrointestinal Surgery

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“…In an earlier double-blind randomized clinical trial, Ertapenem proved to be just as effective as piperacillin-tazobactam [12]. …”

Section: Introductionmentioning

confidence: 99%

A prospective, multi centre, randomized clinical study to compare the efficacy and safety of Ertapenem 3 days versus Ampicillin - Sulbactam 3 days in the treatment of localized community acquired intra-abdominal infection. (T.E.A. Study: Three days Ertapenem vs three days Ampicillin-sulbactam)

Catena

Ansaloni

et al. 2011

BMC Gastroenterol

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BackgroundThe recommendations outlined in the latest guidelines published by the Surgical Infection Society (SIS) and the Infectious Disease Society of America (IDSA) regarding the proper duration of antibiotic therapy in patients with intra-abdominal infections are limited and non-specific. This ambiguity is due mainly to the lack of clinical trials on the topic of optimal duration of therapy. It is well known that the overuse of antibiotics has several important consequences such as increased treatment costs, reduced clinical efficacy, and above all, the increased emergence of antibiotic-resistant pathogens. Ampicillin-Sulbactam is a commonly used "first line" antibiotic for intra-abdominal infections. Ertapenem and Ampicillin-sulbactam are recommended as primary treatment agents for localized peritonitis by both the SIS and IDSA guidelines.Methods/DesignThis study is a prospective multi-center randomized investigation. The study will be performed in the Departments of General, Emergency, and Transplant Surgery of Sant'Orsola-Malpighi University Hospital in Bologna, Italy, in the General Surgery Department of the Ospedali Riuniti of Bergamo, Italy, and in the Trauma and Emergency Surgery Department of Maggiore Hospital in Bologna, Italy, and will be conducted by all surgeons willing to participate in the study. The inclusion period of the study will take approximately two years before the planned number of 142 enrolled patients is reached.DiscussionErtapenem and Ampicillin-sulbactam are recommended both as primary treatment agents for localized peritonitis by both the SIS and IDSA guidelines. As one of the discussed topic is the optimal duration of the antibiotic therapy and this ambiguity is due mainly to the lack of clinical trials on the topic, the present study aims for obtain precise data.Trial RegistrationClinicalTrials.gov: NCT00630513

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“…Although ertapenem has limited activity in vitro against enterococci and Pseudomonas aeruginosa which may be encountered in cIAIs, APIs and cSSSIs, several randomized controlled trials (RCTs) suggested that ertapenem is at least as effective as piperacillin/tazobactam, a β-lactam/β-lactamase inhibitor combination agent that is routinely used in the treatment of these complicated infections [11-16]. Aiming to compare more conclusively the efficacy and safety of ertapenem with piperacillin/tazobactam in these complicated infections, we undertook a system review with meta-analysis of relevant RCTs.…”

Section: Introductionmentioning

confidence: 99%

Ertapenem versus piperacillin/tazobactam for the treatment of complicated infections: a meta-analysis of randomized controlled trials

Zou

Shen

et al. 2009

BMC Infect Dis

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BackgroundErtapenem, a new carbapenem with a favorable pharmacokinetic profile, has been approved for the treatment of complicated intra-abdominal Infections (cIAIs), acute pelvic infections (APIs) and complicated skin and skin-structure infections (cSSSIs). The aim of this study is to compare the efficacy and safety of ertapenem with piperacillin/tazobactam, which has been reported to possess good efficacy for the treatment of these complicated infections.MethodsWe performed a meta-analysis of randomized controlled trials identified in PubMed, Cochrane library and Embase that compared the efficacy and safety of ertapenem with piperacillin/tazobactam for the treatment of complicated infections including cIAIs, APIs, cSSSIs. The primary efficacy outcome was clinical treatment success assessed at the test-of-cure visit. The primary safety outcome was drug related clinical and laboratory adverse events occurred during the treatment and the post-treatment period.ResultSix RCTs, involving 3161 patients, were included in our meta-analysis. Ertapenem was associated similar clinical treatment success with piperacillin/tazobactam for complicated infections treatment (clinically evaluable population, 1937 patients, odds ratios: 1.15, 95% confidence intervals: 0.89-1.49; modified intention to treat population, 2855 patients, odds ratios: 1.03, 95% confidence intervals: 0.87-1.22). All of secondary efficacy outcomes analysis obtained similar findings with clinical treatment success. No difference was found about the incidence of drug related adverse events between ertapenem and piperacillin/tazobactam groups.ConclusionThis meta-analysis provides evidence that ertapenem 1 g once a day can be used as effectively and safely as recommended dose of piperacillin/tazobactam, for the treatment of complicated infections, particularly of mild to moderate severity. It is an appealing option for the treatment of these complicated infections.

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Efficacy and Safety of Ertapenem Versus Piperacillin-Tazobactam for the Treatment of Intra-Abdominal Infections Requiring Surgical Intervention

Cited by 40 publications

References 28 publications

A Prospective, Double-Blind, Multicenter, Randomized Trial Comparing Ertapenem 3 Vs ≥5 Days in Community-Acquired Intraabdominal Infection

A Prospective, Double-Blind, Multicenter, Randomized Trial Comparing Ertapenem 3 Vs ≥5 Days in Community-Acquired Intraabdominal Infection

A prospective, multi centre, randomized clinical study to compare the efficacy and safety of Ertapenem 3 days versus Ampicillin - Sulbactam 3 days in the treatment of localized community acquired intra-abdominal infection. (T.E.A. Study: Three days Ertapenem vs three days Ampicillin-sulbactam)

Ertapenem versus piperacillin/tazobactam for the treatment of complicated infections: a meta-analysis of randomized controlled trials

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