Evidence map›Paper›PMID 23631512›Full record

Trial reportBMC gastroenterology2013

T.E.A. Study: three-day ertapenem versus three-day Ampicillin-Sulbactam.

Fausto Catena, Carlo Vallicelli, Luca Ansaloni, Massimo Sartelli, Salomone Di Saverio, Riccardo Schiavina, Eddi Pasqualini, Annalisa Amaduzzi, Federico Coccolini, Michele Cucchi and 3 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00630513 (A Prospective, Double-blind, Multi Center, 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), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 28% 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.

NCT00630513 phase4completednot on this map

A Prospective, Double-blind, Multi Center, 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 (IAI). (T.E.A. Study Three Days Ertapenem vs Three Days Ampicillin- Sulbactam)

TypeinterventionalSponsorUniversity of BolognaRan2008 to 2010Enrolled142ConditionsIntra-Abdominal InfectionArmsErtapenem, Ampicillin-Sulbactam
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
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 6 institutions in 2 countries.

Fausto CatenaEmergency Surgery Department, Parma University Hospital, Parma, Italy. lavoriscientif@hotmail.it
Carlo Vallicelli
Luca Ansaloni
Massimo Sartelli
Salomone Di Saverio
Riccardo Schiavina
Eddi Pasqualini
Annalisa Amaduzzi
Federico Coccolini
Michele Cucchi
Daniel Lazzareschi
Gian Luca Baiocchi
Antonio D Pinna
Policlinico S.Orsola-Malpighi · ITUniversity of Bergamo · ITUniversity of Brescia · ITUniversity of California, Berkeley · USUniversity of Macerata · ITUniversity of Parma · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntra-abdominal infections are one of the most common infections encountered by a general surgeon. However, despite this prevalence, standardized guidelines outlining the proper use of antibiotic therapy are poorly defined due to a lack of clinical trials investigating the ideal duration of antibiotic treatment. The aim of this study is to compare the efficacy and safety of a three-day treatment regimen of Ampicillin-Sulbactam to that of a three-day regimen of Ertapenem in patients with localized peritonitis ranging from mild to moderate severity.

methodsThis study is a prospective, multi-center, randomized investigation performed in the Department of General, Emergency, and Transplant Surgery of St. Orsola-Malpighi University Hospital in Bologna, Italy. Discrete data were analyzed using the Chi-squared and Fisher exact tests. Differences between the two study groups were considered statistically significant for p-values less than 0.05.

results71 patients were treated with Ertapenem and 71 patients were treated with Ampicillin-Sulbactam. The two groups were comparable in terms of age and gender as well as the site of abdominal infection. Post-operative infection was identified in 12 patients: 10 with wound infections and 2 with intra-abdominal infections. In the Ertapenem group, 69 of the 71 patients (97%) were treated successfully, while the therapy failed in 2 cases (3%). Therapy failures were more frequent in the Unasyn group, amounting to 10 of 71 cases (p = 0.03).

conclusionAccording to these preliminary findings, the authors conclude that a three-day Ertapenem treatment regimen is the most effective antibiotic therapy for patients with localized intra-abdominal infections ranging from mild to moderate severity.

trial registrationTrial registration: ClinicalTrials.gov: NCT00630513.

Indexed as

AmpicillinAnti-Bacterial Agentsbeta-LactamsChi-Square DistributionDrug Administration ScheduleErtapenemFemaleHumansMaleMiddle AgedPeritonitisSulbactamSurgical Wound InfectionTreatment OutcomeAmpicillinAnti-Bacterial Agentsbeta-LactamsErtapenemSulbactamsultamicillin

Identifiers

PMID23631512
PMCPMC3660242
OpenAlexW2083974084

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.