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) - TEA Study

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2007年10月15日最近更新: 2014年2月24日

试验速览

暂无简介。

•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

•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.

发起方

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI