minocycline and Diverticulitis

Source control, any procedure used to control the source of a major infection, is critical to the resolution of intra-abdominal infections. We sought to characterize whether surgeons agree on methods of source control for patients who had persistent infection despite initial surgical treatment and antimicrobials.. We analyzed source control decisions in a trial comparing tigecycline with imipenem in the treatment of intra-abdominal infections for patients who were clinical failures and had persistent abdominal infections after treatment with antibiotics and undergoing source control.. We found that source control agreement was least among patients who had Acute Physiology and Chronic Health Evaluation (APACHE) II scores greater than 15 (kappa = -.17, P = .533) and those with complicated appendicitis (kappa = .08, P = .446). There was excellent agreement in the source control decisions for perforation (kappa = .76, P = 0.002) and diverticulitis (kappa = 1.00, P = .005).. Agreement on source control is lacking on more severely ill patients and those with complicated appendicitis. These data should be used to seek optimal management for these conditions and to minimize variability in future clinical trials of intra-abdominal infection.

Topics: Abdominal Abscess; Abdominal Cavity; Aged; Anti-Bacterial Agents; Appendicitis; Cholecystitis; Decision Making; Digestive System Diseases; Diverticulitis; Double-Blind Method; Female; Humans; Imipenem; Intestinal Perforation; Male; Middle Aged; Minocycline; Peritonitis; Professional Practice; Tigecycline

Complicated intra-abdominal infections (cIAI) remain challenging to treat because of their polymicrobial etiology including multi-drug resistant bacteria. The efficacy and safety of tigecycline, an expanded broad-spectrum glycylcycline antibiotic, was compared with imipenem/cilastatin (IMI/CIS) in patients with cIAI.. A prospective, double-blind, multinational trial was conducted in which patients with cIAI randomly received intravenous (IV) tigecycline (100 mg initial dose, then 50 mg every 12 hours [q12h]) or IV IMI/CIS (500/500 mg q6h or adjusted for renal dysfunction) for 5 to14 days. Clinical response at the test-of-cure (TOC) visit (14-35 days after therapy) for microbiologically evaluable (ME) and microbiological modified intent-to-treat (m-mITT) populations were the co-primary efficacy endpoint populations.. A total of 825 patients received >or= 1 dose of study drug. The primary diagnoses for the ME group were complicated appendicitis (59%), and intestinal (8.8%) and gastric/duodenal perforations (4.6%). For the ME group, clinical cure rates at TOC were 80.6% (199/247) for tigecycline versus 82.4% (210/255) for IMI/CIS (95% CI -8.4, 5.1 for non-inferiority tigecycline versus IMI/CIS). Corresponding clinical cure rates within the m-mITT population were 73.5% (227/309) for tigecycline versus 78.2% (244/312) for IMI/CIS (95% CI -11.0, 2.5). Nausea (31.0% tigecycline, 24.8% IMI/CIS [P = 0.052]), vomiting (25.7% tigecycline, 19.4% IMI/CIS [P = 0.037]), and diarrhea (21.3% tigecycline, 18.9% IMI/CIS [P = 0.435]) were the most frequently reported adverse events.. This study demonstrates that tigecycline is as efficacious as imipenem/cilastatin in the treatment of patients with cIAI.

Topics: Abdomen; Adult; Anti-Bacterial Agents; Appendicitis; Bacterial Infections; Cholecystitis; Cilastatin; Cilastatin, Imipenem Drug Combination; Diverticulitis; Double-Blind Method; Drug Combinations; Female; Humans; Imipenem; Intestinal Perforation; Male; Middle Aged; Minocycline; Peptic Ulcer Perforation; Peritonitis; Tigecycline

Topics: Acute Disease; Aged; Anti-Bacterial Agents; Bacteremia; Diverticulitis; Female; Humans; Minocycline; Tigecycline; Tomography, X-Ray Computed