Clinical trial NCT00630513: T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intra-Abdominal Infection
Keywords: localized community acquired intra-abdominal infection (IAI)
antibiotics
localized peritonitis
ertapenem
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
First posted: 2008-03-07
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI
timeFrame: 3 days
Secondary outcomes:
measure: Any other complication
timeFrame: intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up
measure: The total costs of antibiotic therapy
timeFrame: during hospital stay
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: S.Orsola-Malpighi University Hospital - University of Bologna
Study officials:
affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
name: Fausto Catena, MD PhD
role: STUDY_DIRECTOR
affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
name: Luca Ansaloni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
name: Giorgio Ercolani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
name: Antonio Daniele Pinna, MD
role: STUDY_CHAIR
affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
name: Cristina Puggioli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
name: Salomone Di Saverio, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.