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| Tracking Information | |||||||||||||||||||||||||
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| First Received Date ICMJE | February 27, 2008 | ||||||||||||||||||||||||
| Last Updated Date | September 8, 2008 | ||||||||||||||||||||||||
| Start Date ICMJE | January 2008 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI [ Time Frame: 3 days ] [ Designated as safety issue: Yes ] | ||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00630513 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam | ||||||||||||||||||||||||
| Official Title ICMJE | 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) | ||||||||||||||||||||||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||||||||||||||||||
| Condition ICMJE | Intra-Abdominal Infection | ||||||||||||||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| 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. | ||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 142 | ||||||||||||||||||||||||
| Estimated Completion Date | September 2010 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | 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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| Gender | Both | ||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT ID ICMJE | NCT00630513 | ||||||||||||||||||||||||
| Responsible Party | Dr. Fausto Catena MD PhD, University of Bologna - St Orsola-Malpighi University Hospital | ||||||||||||||||||||||||
| Study ID Numbers ICMJE | T.E.A. Study | ||||||||||||||||||||||||
| Study Sponsor ICMJE | University of Bologna | ||||||||||||||||||||||||
| Collaborators ICMJE | St. Orsola Hospital | ||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Bologna | ||||||||||||||||||||||||
| Verification Date | September 2008 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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