T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam (TEA)

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)

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.

Study Overview

• Status: Completed
• Conditions: Intra-Abdominal Infection
• Intervention / Treatment: Drug: Ertapenem; Drug: Ampicillin-Sulbactam

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • S.Orsola-Malpighi University Hospital - University of Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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):

• Acute appendicitis: Ruptured or perforated with abscess
• Acute diverticulitis with perforation and/or abscess
• Acute cholecystitis (including gangrenous) with either rupture or perforation
• Acute gastric and duodenal ( > 24 hours) perforation
• Traumatic (> 12 hours) perforation of the intestines
• Secondary peritonitis due to perforated viscus
• Intra-abdominal abscess (including of liver and spleen)

Exclusion Criteria:

• Traumatic bowel perforation requiring surgery within 12 hours
• Perforation of gastroduodenal ulcers requiring surgery within 24 hours
• other intra-abdominal processes in which the primary etiology was unlikely to be infectious.
• Patients lactating or pregnant
• Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics
• Patients with rapidly progressive or terminal illness;
• Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance < 0.5 ml/min/1.73 m2);
• Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E; 3 days regimen with Ertapenem	Drug: Ertapenem; 3 days regimen with Ertapenem (1 g/day i.v.)
Active Comparator: AS; 3 days treatment with Ampicillin-Sulbactam	Drug: Ampicillin-Sulbactam; 3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI	3 days

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Bologna
• Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Luca Ansaloni, MD, S.Orsola-Malpighi University Hospital - University of Bologna; Principal Investigator: Salomone Di Saverio, M.D., S.Orsola-Malpighi University Hospital - University of Bologna; Study Director: Fausto Catena, MD PhD, S.Orsola-Malpighi University Hospital - University of Bologna; Principal Investigator: Giorgio Ercolani, MD, S.Orsola-Malpighi University Hospital - University of Bologna; Study Chair: Antonio Daniele Pinna, MD, S.Orsola-Malpighi University Hospital - University of Bologna; Principal Investigator: Cristina Puggioli, MD, S.Orsola-Malpighi University Hospital - University of Bologna

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 27, 2008
• First Submitted That Met QC Criteria: February 27, 2008
• First Posted (Estimate): March 7, 2008

Study Record Updates

• Last Update Posted (Estimate): August 18, 2011
• Last Update Submitted That Met QC Criteria: August 17, 2011
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: antibiotics; ertapenem; localized community acquired intra-abdominal infection (IAI); localized peritonitis
• Additional Relevant MeSH Terms: Infections; Intraabdominal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Ampicillin; Ertapenem; Sulbactam; Sultamicillin
• Other Study ID Numbers: T.E.A. Study