Intra-Abdominal Infection
Conditions
Keywords
localized community acquired intra-abdominal infection (IAI), antibiotics, localized peritonitis, ertapenem
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.
Interventions
DRUGErtapenem
3 days regimen with Ertapenem (1 g/day i.v.)
3 days treatment with Ampicillin-Sulbactam (AS 3g x 3/ day i.v.)
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the failure rate of short therapy with Ertapenem and with AS in localized IAI | 3 days |
Secondary
| 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 |
Countries
Italy
Outcome results
None listed