localized community acquired intra-abdominal infection (IAI) MedDRA version: 6.1 Level: HLT Classification code 10017967
Conditions
Interventions
Trade Name: UNASYN*EV 1FL 1G+2G
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: AMPICILLINA
CAS Number: 69-53-4
Concentration unit: % percent
Concentration type: equal
Concentration num
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (>18 years) to require surgical intervention within 24 hours of diagnosis. 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 |
|---|---|
| Main Objective: To compare in patients with mild to moderate form of localized peritonitis (appendicitis vs non appendicitis) the clinical and bacteriological efficacy and tolerability of a 3 days treatment with Ampicillin- Sulbactam (AS 3g x 3/ day i.v.) vs a 3 days regimen with Ertapenem (1 g/day i.v.);Secondary Objective: None declared;Primary end point(s): The primary endpoint of the study will be: To compare the failure rate of short therapy with Ertapenem and with AS in localized IAI The onset of any other complications will be recorded intraoperatively, postoperatively, at discharge, at 7-days, 1-month, 6-months follow-up. | — |
Countries
Italy
Outcome results
None listed