T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam - Full Text View

Sponsor:	University of Bologna
Collaborator:	St. Orsola Hospital
Information provided by:	University of Bologna
ClinicalTrials.gov Identifier:	NCT00630513

Purpose

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.

Condition	Intervention	Phase
Intra-Abdominal Infection	Drug: Ertapenem Drug: Ampicillin-Sulbactam	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Ampicillin sodium Ampicillin Sulbactam Sulbactam sodium Sultamicillin L 749345 Ertapenem Ampicillin trihydrate

U.S. FDA Resources

Further study details as provided by University of Bologna:

Primary Outcome Measures:

Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Any other complication [ Time Frame: intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up ] [ Designated as safety issue: Yes ]
The total costs of antibiotic therapy [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment:	142
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
E: Experimental 3 days regimen with Ertapenem	Drug: Ertapenem 3 days regimen with Ertapenem (1 g/day i.v.)
AS: Active Comparator 3 days treatment with Ampicillin-Sulbactam	Drug: Ampicillin-Sulbactam 3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630513

Contacts

Contact: Fausto Catena, MD PhD

+390516363235

fausto.catena@aosp.bo.it

Locations

Italy
S.Orsola-Malpighi University Hospital - University of Bologna	Recruiting
BOLOGNA, Italy
Contact: Fausto Catena, M.D. PhD +396363235 fausto.catena@aosp.bo.it
Principal Investigator: Fausto Catena, M.D. PhD
Principal Investigator: Luca Ansaloni, M.D.
Sub-Investigator: Filippo Gazzotti, M.D.
Sub-Investigator: Luigi D'Alessandro, M.D.
Principal Investigator: Giorgio Ercolani, MD
Principal Investigator: Antonio Daniele Pinna, MD
Principal Investigator: Cristina Puggioli, MD
Sub-Investigator: Federico Coccolini, MD
Principal Investigator: Salomone Di Saverio, M.D.

Sponsors and Collaborators

University of Bologna

St. Orsola Hospital

Investigators

Study Director:	Fausto Catena, MD PhD	S.Orsola-Malpighi University Hospital - University of Bologna
Principal Investigator:	Luca Ansaloni, MD	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
Principal Investigator:	Salomone Di Saverio, M.D.	S.Orsola-Malpighi University Hospital - University of Bologna

More Information

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 >/=5 days in community-acquired intraabdominal infection. J Gastrointest Surg. 2008 Mar;12(3):592-600. Epub 2007 Sep 11.

Responsible Party:	University of Bologna - St Orsola-Malpighi University Hospital ( Dr. Fausto Catena MD PhD )
Study ID Numbers:	T.E.A. Study
Study First Received:	February 27, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00630513 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Bologna:

localized community acquired intra-abdominal infection (IAI)
antibiotics
localized peritonitis
ertapenem

Additional relevant MeSH terms:

Ertapenem
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Ampicillin
Enzyme Inhibitors
Sultamicillin
Infection
Pharmacologic Actions
Sulbactam

ClinicalTrials.gov processed this record on November 27, 2009