Evidence map›Paper›PMID 12560782›Full record

Trial reportAnnals of surgery2003

Ertapenem versus piperacillin/tazobactam in the treatment of complicated intraabdominal infections: results of a double-blind, randomized comparative phase III trial.

Joseph S Solomkin, Albert E Yellin, Ori D Rotstein, Nicolas V Christou, E Patchen Dellinger, Jose M Tellado, Osvaldo Malafaia, Alvaro Fernandez, Kyuran A Choe, Alexandra Carides and 3 more

Registry-linked trialOpen access · greenAbstract readClinical TrialClinical Trial, Phase IIIComparative Study
In one paragraph

Trial report in Annals of surgery, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00097734 (A Prospective, Multicenter, Open-Label, Randomized Clinical Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis), which is not on this map. Cited by 50 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 7 pooled it
9.5field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00097734 phase4unknown statusnot on this mapstarted 2004, after this paper: background citation

A Prospective, Multicenter, Open-Label, Randomized Clinical Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis

TypeinterventionalSponsorKlinikum Hanover-Siloah HospitalRan2004 to 2007Enrolled540ConditionsDiverticulitis, Colonic, Acute DiseaseArmsertapenem
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 7 syntheses or guidelines pooled it, 180 citations in OpenAlex.

  1. Pooled it
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  6. Carbapenems versus other beta-lactams in treating severe infections in intensive care: a systematic review of randomised controlled trials.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2008
    Pooled it
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  8. Trial
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  13. A prospective, double-blind, multicenter, randomized trial comparing ertapenem 3 vs >or=5 days in community-acquired intraabdominal infection.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2008
    Trial
  14. Efficacy and safety of ertapenem versus piperacillin-tazobactam for the treatment of intra-abdominal infections requiring surgical intervention.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2006
    Trial
  15. Trial
  16. Bowel colonization with resistant gram-negative bacilli after antimicrobial therapy of intra-abdominal infections: observations from two randomized comparative clinical trials of ertapenem therapy.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2005
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  17. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 1 institution in 1 country.

Joseph S SolomkinDepartment of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267-0558, USA. joseph.solomkin@uc.edu
Albert E Yellin
Ori D Rotstein
Nicolas V Christou
E Patchen Dellinger
Jose M Tellado
Osvaldo Malafaia
Alvaro Fernandez
Kyuran A Choe
Alexandra Carides
Vilas Satishchandran
Hedy Teppler
Protocol 017 Study Group
University of Cincinnati Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo examine the clinical efficacy and safety of ertapenem, a novel beta-lactam agent with wide activity against common pathogens encountered in intraabdominal infection. SUMMARY BACKGROUND DATA: Ertapenem has a pharmacokinetic profile and antimicrobial spectrum that support the potential for use as a once-a-day agent for the treatment of common mixed aerobic and anaerobic infections. METHODS This prospective, randomized, controlled, and double-blind trial was conducted to compare the safety and efficacy of ertapenem with piperacillin/tazobactam as therapy following adequate surgical management of complicated intraabdominal infections.

resultsSix hundred thirty-three patients were included in the modified intent-to-treat population, with 396 meeting all criteria for the evaluable population. Patients with a wide range of infections were enrolled; perforated or abscessed appendicitis was most common (approximately 60% in microbiologically evaluable population). A prospective, expert panel review was conducted to assess the adequacy of surgical source control in patients who were failures as a component of evaluability. For the modified intent-to-treat groups, 245 of 311 patients treated with ertapenem (79.3%) were cured, as were 232 of 304 (76.2) treated with piperacillin/tazobactam. One hundred seventy-six of 203 microbiologically evaluable patients treated with ertapenem (86.7%) were cured, as were 157 of the 193 (81.2%) treated with piperacillin/tazobactam.

conclusionsIn this study, the efficacy of ertapenem 1 g once a day was equivalent to piperacillin/tazobactam 3.375 g every 6 hours in the treatment of a range of intraabdominal infections. Ertapenem was generally well tolerated and had a similar safety and tolerability profile to piperacillin/tazobactam. A formal process for review of adequacy of source control was found to be of benefit. The results of this trial suggest that ertapenem may be a useful option that could eliminate the need for combination and/or multidosed antibiotic regimens for the empiric treatment of intraabdominal infections.

Indexed as

LactamsAbdominal AbscessAdolescentAdultAgedAged, 80 and overAnti-Bacterial Agentsbeta-LactamsDigestive System Surgical ProceduresDouble-Blind MethodDrug Therapy, CombinationErtapenemFemaleGram-Negative Bacterial InfectionsGram-Positive Bacterial InfectionsHospitalizationAnti-Bacterial Agentsbeta-LactamsErtapenemLactamsPenicillanic AcidPiperacillinPiperacillin, Tazobactam Drug Combination

Identifiers

PMID12560782
PMCPMC1522141
OpenAlexW1967549517

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.