cilastatin--imipenem-drug-combination and Gangrene

The objective of this study was to compare ticarcillin/clavulanate given at 3.1 g every 6 hours with imipenem/cilistatin given at 500 mg every 6 hours for the treatment of infections associated with gangrenous or perforated appendicitis. One hundred thirty-seven patients were found to have gangrenous or perforated appendicitis and received the study medication for 3 to 5 days in a double-blinded, randomized manner. Clinical success was similar for the two treatment groups, 96.9 and 95.9 per cent in the ticarcillin/clavulanate and imipenem/cilistatin groups, respectively (P=0.99; 95% confidence interval for the difference was -5.6% to 7.6%). Bacteriologic success at the end of therapy was similar in the two groups, 100 and 98.4 per cent in the ticarcillin/clavulanate and imipenem/ cilistatin groups, respectively (P=0.99; 95% confidence interval for the difference was -1.8% to 4.7%). The occurrence of adverse events related to treatment was similar for the two groups (P=0.31) and led to study withdrawal for four patients (one with ticarcillin/clavulanate and three with imipenem/ cilistatin). Ticarcillin/clavulanate given at 3.1 g every 6 hours is as effective and as safe as imipenem/ cilistatin given at 500 mg every 6 hours for treatment of gangrenous or perforated appendicitis.

Topics: Adolescent; Adult; Aged; Appendicitis; Appendix; Child; Cilastatin; Cilastatin, Imipenem Drug Combination; Clavulanic Acids; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Gangrene; Humans; Imipenem; Intestinal Perforation; Male; Middle Aged; Prospective Studies; Ticarcillin; Treatment Outcome

An open-label prospective study was performed employing intramuscularly administered imipenem as an adjunct to surgery in 20 patients with acute cholecystitis and 24 patients with perforated or gangrenous appendicitis. Three (12.5%) septic failures occurred in appendicitis patients and 2 (10%) failures in cholecystitis patients. There were no deaths. Adverse effects were minor, and there was no toxicity. Although failures were not associated with in vitro resistance, Pseudomonas spp. were recovered from 2 of 3 appendicitis failures. Intramuscular imipenem appeared to be an effective single-drug antimicrobial when used as an adjunct to surgery in patients with acute cholecystitis or perforated appendicitis. It should be a more cost-effective alternative to the current multiple-drug therapy frequently employed in patients with intra-abdominal sepsis.

Topics: Adult; Appendicitis; Cholecystitis; Cilastatin; Cilastatin, Imipenem Drug Combination; Combined Modality Therapy; Drug Combinations; Female; Gangrene; Half-Life; Humans; Imipenem; Injections, Intramuscular; Intestinal Perforation; Lidocaine; Male; Prospective Studies; Rupture, Spontaneous