Evidence map›Paper›PMID 21501482›Full record

Trial reportBMC gastroenterology2011

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).

Federico Coccolini, Fausto Catena, Luca Ansaloni, Giorgio Ercolani, Salomone Di Saverio, Filippo Gazzotti, Daniel Lazzareschi, Antonio D Pinna

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2011. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.2field-weighted citation impact, top 21% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Trial
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

8 authors at 3 institutions in 2 countries.

Federico CoccoliniUnit of General, Emergency and Transplant Surgery, St, Orsola-Malpighi University Hospital, Bologna, Italy. fedecocco@iol.it
Fausto Catena
Luca Ansaloni
Giorgio Ercolani
Salomone Di Saverio
Filippo Gazzotti
Daniel Lazzareschi
Antonio D Pinna
Policlinico S.Orsola-Malpighi · ITAzienda Ospedaliero Universitaria Ospedali Riuniti · ITUniversity of California, Berkeley · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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. DISCUSSION: Ertapenem 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.

Indexed as

AbdomenAdultAmpicillinAnti-Bacterial AgentsBacterial Infectionsbeta-LactamsClinical ProtocolsCommunity-Acquired InfectionsDrug Therapy, CombinationErtapenemHumansPeritonitisSulbactamAmpicillinAnti-Bacterial Agentsbeta-LactamsErtapenemSulbactam

Identifiers

PMID21501482
PMCPMC3090366
OpenAlexW1976588007

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.