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| Name | Class |
|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER |
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The aim of the study was to compare the activity (efficacy and safety) of Ertapenem administered according to a short treatment for three days versus a short treatment for three days with AS in patients with an community acquired IAI of mild to moderate severity.
The study project is a prospective, randomized controlled investigation. The study will be performed in the Department of Transplant, General and Emergency Surgery of St Orsola-Malpighi University Hospital (Bologna, Italy), a large teaching institution, with the participation of all surgeons who accept to be involved in.
The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations.
The tolerability and efficacy of a 3 days treatment with Ampicillin- Sulbactam (AS 3g x 3/ day i.v.) is compared a 3 days regimen with Ertapenem (1 g/day i.v.). in patients with localized peritonitis with a blinded evaluation of efficacy end points. Evaluation of cure or failure is blinded by use of designated third party individuals who are unaware of the treatment assigned to the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E | Experimental | 3 days regimen with Ertapenem |
|
| AS | Active Comparator | 3 days treatment with Ampicillin-Sulbactam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertapenem | Drug | 3 days regimen with Ertapenem (1 g/day i.v.) |
| |
| Ampicillin-Sulbactam |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Any other complication | intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up | |
| The total costs of antibiotic therapy | during hospital stay |
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Inclusion Criteria:
Adult patients ( > 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fausto Catena, MD PhD | S.Orsola-Malpighi University Hospital - University of Bologna | Study Director |
| Luca Ansaloni, MD | S.Orsola-Malpighi University Hospital - University of Bologna | Principal Investigator |
| Giorgio Ercolani, MD | S.Orsola-Malpighi University Hospital - University of Bologna | Principal Investigator |
| Antonio Daniele Pinna, MD | S.Orsola-Malpighi University Hospital - University of Bologna | Study Chair |
| Cristina Puggioli, MD | S.Orsola-Malpighi University Hospital - University of Bologna | Principal Investigator |
| Salomone Di Saverio, M.D. | S.Orsola-Malpighi University Hospital - University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.Orsola-Malpighi University Hospital - University of Bologna | Bologna | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17846853 | Background | Basoli A, Chirletti P, Cirino E, D'Ovidio NG, Doglietto GB, Giglio D, Giulini SM, Malizia A, Taffurelli M, Petrovic J, Ecari M; Italian Study Group. A prospective, double-blind, multicenter, randomized trial comparing ertapenem 3 vs >or=5 days in community-acquired intraabdominal infection. J Gastrointest Surg. 2008 Mar;12(3):592-600. doi: 10.1007/s11605-007-0277-x. Epub 2007 Sep 11. | |
| 23631512 |
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| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077727 | Ertapenem |
| C035444 | sultamicillin |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Drug |
3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.) |
|
| Derived |
| Catena F, Vallicelli C, Ansaloni L, Sartelli M, Di Saverio S, Schiavina R, Pasqualini E, Amaduzzi A, Coccolini F, Cucchi M, Lazzareschi D, Baiocchi GL, Pinna AD. T.E.A. Study: three-day ertapenem versus three-day Ampicillin-Sulbactam. BMC Gastroenterol. 2013 Apr 30;13:76. doi: 10.1186/1471-230X-13-76. |
| 21501482 | Derived | Coccolini F, Catena F, Ansaloni L, Ercolani G, Di Saverio S, Gazzotti F, Lazzareschi D, Pinna AD. 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 Gastroenterol. 2011 Apr 18;11:42. doi: 10.1186/1471-230X-11-42. |
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |