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)
<p>Abstract</p> <p>Background</p> <p>The 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-a...
Main Authors: | , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2011-04-01
|
Series: | BMC Gastroenterology |
Online Access: | http://www.biomedcentral.com/1471-230X/11/42 |
id |
doaj-99fa0e3ec8824506bc5a16afef84c2df |
---|---|
record_format |
Article |
spelling |
doaj-99fa0e3ec8824506bc5a16afef84c2df2020-11-25T03:40:27ZengBMCBMC Gastroenterology1471-230X2011-04-011114210.1186/1471-230X-11-42A 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)Gazzotti FilippoDi Saverio SalomoneErcolani GiorgioAnsaloni LucaCatena FaustoCoccolini FedericoLazzareschi DanielPinna Antonio D<p>Abstract</p> <p>Background</p> <p>The 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.</p> <p>Methods/Design</p> <p>This 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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00630513">NCT00630513</a></p> http://www.biomedcentral.com/1471-230X/11/42 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Gazzotti Filippo Di Saverio Salomone Ercolani Giorgio Ansaloni Luca Catena Fausto Coccolini Federico Lazzareschi Daniel Pinna Antonio D |
spellingShingle |
Gazzotti Filippo Di Saverio Salomone Ercolani Giorgio Ansaloni Luca Catena Fausto Coccolini Federico Lazzareschi Daniel Pinna Antonio D 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) BMC Gastroenterology |
author_facet |
Gazzotti Filippo Di Saverio Salomone Ercolani Giorgio Ansaloni Luca Catena Fausto Coccolini Federico Lazzareschi Daniel Pinna Antonio D |
author_sort |
Gazzotti Filippo |
title |
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) |
title_short |
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) |
title_full |
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) |
title_fullStr |
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) |
title_full_unstemmed |
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) |
title_sort |
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) |
publisher |
BMC |
series |
BMC Gastroenterology |
issn |
1471-230X |
publishDate |
2011-04-01 |
description |
<p>Abstract</p> <p>Background</p> <p>The 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.</p> <p>Methods/Design</p> <p>This 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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00630513">NCT00630513</a></p> |
url |
http://www.biomedcentral.com/1471-230X/11/42 |
work_keys_str_mv |
AT gazzottifilippo aprospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT disaveriosalomone aprospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT ercolanigiorgio aprospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT ansaloniluca aprospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT catenafausto aprospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT coccolinifederico aprospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT lazzareschidaniel aprospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT pinnaantoniod aprospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT gazzottifilippo prospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT disaveriosalomone prospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT ercolanigiorgio prospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT ansaloniluca prospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT catenafausto prospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT coccolinifederico prospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT lazzareschidaniel prospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam AT pinnaantoniod prospectivemulticentrerandomizedclinicalstudytocomparetheefficacyandsafetyofertapenem3daysversusampicillinsulbactam3daysinthetreatmentoflocalizedcommunityacquiredintraabdominalinfectionteastudythreedaysertapenemvsthreedaysampicillinsulbactam |
_version_ |
1724534841573113856 |