Table 4.

Exclusion criteria for clinical trial of tigecycline in patients with complicated intraabdominal infections^∗

Suspicion of spontaneous bacterial peritonitis

Simple cholecystitis

Gangrenous cholecystitis without rupture

Simple appendicitis

Acute suppurative cholangitis

Pancreatic abscess

APACHE II score of >30

Active or treated leukemia or systemic malignancy within prior 3 months

Metastatic abdominal cancer within prior 6 months

Known AIDS

Uncontrolled central nervous system disease

Pregnancy or breast-feeding

Hypersensitivity to either study drug or related compounds

Concomitant ganciclovir therapy

Significant hepatic disease (AST/ALT >10× ULN or total bilirubin >3× ULN)

Acute hepatic failure or acute decompensation of chronic hepatic failure

Significant renal disease (creatinine clearance <41 mL/min)

Neutropenia with absolute neutrophil count <1000/mm3

Abdominal infection caused by one or more bacteria not susceptible to either of the study drugs

Surgical procedures with expected re-exploration

Administration of intraoperative or peritoneal antimicrobial irrigants

∗From reference 14.

APACHE II indicates Acute Physiology and Chronic Health Evaluation II; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal.