Intra-Abdominal InfectionPhase 4TEANCT00630513
T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam
A Phase 4 study testing Ertapenem and Ampicillin-Sulbactam in people with Intra-Abdominal Infection, run by University of Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Infection
- What is being tested?
- Ertapenem and Ampicillin-Sulbactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
S.Orsola-Malpighi University Hospital - University of Bologna
Bologna
About this 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)
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.
Read the 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.
- Conditions
- Intra-Abdominal Infection
- Being tested
- Ertapenem, Ampicillin-Sulbactam
- Keywords
- localized community acquired intra-abdominal infection (IAI), antibiotics, localized peritonitis, ertapenem
- Medical subject headings
- Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtapenemDrug
3 days regimen with Ertapenem (1 g/day i.v.)
Ampicillin-SulbactamDrug
3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)
| Study group | Role | What they receive |
|---|---|---|
| E | Experimental | 3 days regimen with Ertapenem Receives: Drug: Ertapenem |
| AS | Active comparator | 3 days treatment with Ampicillin-Sulbactam Receives: Drug: Ampicillin-Sulbactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI
Measured: 3 days
Secondary outcomes (2)
Any other complication
Measured: intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up
The total costs of antibiotic therapy
Measured: during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intra-Abdominal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Fausto Catena, MD PhD, Study director, S.Orsola-Malpighi University Hospital - University of BolognaLuca Ansaloni, MD, Principal investigator, S.Orsola-Malpighi University Hospital - University of BolognaGiorgio Ercolani, MD, Principal investigator, S.Orsola-Malpighi University Hospital - University of BolognaAntonio Daniele Pinna, MD, Study chair, S.Orsola-Malpighi University Hospital - University of BolognaCristina Puggioli, MD, Principal investigator, S.Orsola-Malpighi University Hospital - University of BolognaSalomone Di Saverio, M.D., Principal investigator, S.Orsola-Malpighi University Hospital - University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630513
- Sponsor's protocol ID
- T.E.A. Study
- Acronym
- TEA
- Status last verified
- Sep 2008
- First submitted
- 27 Feb 2008
- Last updated
- 18 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17846853Catena 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.
PubMed 23631512Coccolini 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.
PubMed 21501482
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00630513
- Acronym / sponsor ID
- TEA / T.E.A. Study
- Conditions
- Intra-Abdominal Infection
- Keywords
- localized community acquired intra-abdominal infection (IAI), antibiotics, localized peritonitis, ertapenem
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E | Experimental | Drug: Ertapenem3 days regimen with Ertapenem |
| AS | Active comparator | Drug: Ampicillin-Sulbactam3 days treatment with Ampicillin-Sulbactam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ertapenem3 days regimen with Ertapenem (1 g/day i.v.) | Drug | E |
| Ampicillin-Sulbactam3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.) | Drug | AS |
Primary outcome
Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI
Time frame: 3 days
2 secondary outcomes
Any other complication
Time frame: intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up
The total costs of antibiotic therapy
Time frame: during hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2011.
- Background: PubMed 17846853Basoli 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.
- Derived from this study: PubMed 23631512Catena 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.
- Derived from this study: PubMed 21501482Coccolini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fausto Catena, MD PhD study director
S.Orsola-Malpighi University Hospital - University of Bologna
Luca Ansaloni, MD principal investigator
S.Orsola-Malpighi University Hospital - University of Bologna
Giorgio Ercolani, MD principal investigator
S.Orsola-Malpighi University Hospital - University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ertapenem and Ampicillin-Sulbactam in people with Intra-Abdominal Infection, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00630513, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2011.