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Table 1 Enrollment criteria

From: Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial

Inclusion* Exclusion
Men and non-pregnant, non-lactating women ≥18 years of age who required a surgical procedure for a complicated intra-abdominal infection (cIAI)
cIAI defined as the following:
An intra-abdominal abscess (including liver and spleen) that developed in a postsurgical patient after receiving standard antibacterial therapy (i.e., at least 48 hours, but not more than 5 days of antibiotics);
Appendicitis complicated by perforation and/or a periappendiceal abscess;
Perforated diverticulitis complicated by abscess formation or fecal contamination;
Complicated cholecystitis with evidence of perforation or empyema; perforation of a gastric or duodenal ulcer with symptoms exceeding 24 hours;
Purulent peritonitis or peritonitis associated with fecal contamination;
Perforation of the large or small intestine with abscess or fecal contamination, or traumatic bowel perforation with symptoms lasting at least 12 hours before an operation
Preoperative suspicion of a diagnosis of spontaneous bacterial peritonitis, simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, pancreatic abscess, or infected necrotizing pancreatitis;
Acute Physiologic and Chronic Health Evaluation (APACHE) II score greater than 30;
Surgical procedure requiring that fascia or deep muscular layers be left open or expectation of planned abdominal re-exploration either in or out of the operating room;
Use of immunosuppressive therapy that would decrease the patient's ability to eradicate the infection, including use of high-dose corticosteroids (e.g., 40 mg or more of prednisone or an equivalent per day for more than 3 weeks before randomization) or known diagnosis of acquired immunodeficiency syndrome;
Current intra-abdominal infection known to be caused by one or more bacterial isolates not susceptible to either of the study drugs (e.g., P. aeruginosa, Proteus mirabilis);
Active or treated leukemia or systemic malignancy that requires chemotherapy, immunotherapy, radiation therapy, or antineoplastic therapy within the 3 months before enrollment, or any metastatic malignancy to the abdomen with life expectancy < 6 months;
Presence of any uncontrolled central nervous system disease;
Significant hepatic disease (i.e., aspartate aminotransferase [AST] or alanine aminotransferase [ALT] level > 10 times the upper limit of normal [ULN] or total bilirubin value > 3 times the ULN) or acute hepatic failure or acute decompensation of chronic hepatic failure;
Significant renal disease (i.e., calculated creatinine clearance < 41 mL/min/1.73 m2 after adequate hydration);
Neutropenia with absolute neutrophil count < 1000 mm3 (however, neutrophil counts as low as 500 cells/mm3 permitted if secondary to the acute infectious process);
Concomitant treatment with ganciclovir
  1. *Patients had to satisfy the inclusion criteria to be considered eligible for study participation
  2. Patients were ineligible for study participation if they had one or more of the listed exclusions