Efficacy of two comparative antibiotic regimens in the treatment of serious intra-abdominal infections: results of a multicenter study.
A multicenter, open-label randomized trial was conducted to evaluate the efficacy and tolerability of monotherapy with imipenem-cilastatin (I-C) compared with combination therapy with clindamycin and an aminoglycoside (C+A) for treatment of 117 patients with serious intra-abdominal infections. Fifty-three patients (45%) received I-C and 64 patients (55%) received C+A. The overall clinical success rate was 96.2% for the I-C patients and 92.2% for the C+A patients. Clinical failure rates were 3.8% and 7.8%, respectively (P = NS). Eradication or suppression of pathogens was observed in 81.8% and 82.2% of patients, respectively. Uniform bacteriologic response was observed among all infection subgroups. Fourteen of 145 patients experienced adverse symptoms, including six of 66 (9.1%) monotherapy patients and eight of 79 (10.1%) combination-therapy patients (P = NS). The results of this study demonstrate that I-C monotherapy was as effective as C+A combination therapy for the treatment of serious intra-abdominal infections, regardless of the site or severity of infection or the clinical status of the patient. Both regimens also were found to be comparable in tolerability.
Eckhauser
F E
FE
Division of GI Surgery, University of Michigan Medical School, Ann Arbor.
Knol
J A
JA
Raper
S E
SE
Mulholland
M W
MW
Helzerman
P
P
D000005:Abdomen / Q000382:microbiology*; D000368:Aged; D000369:Aged, 80 and over; D000617:Aminoglycosides; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D001442:Bacteroides Infections / Q000188:drug therapy; D015377:Cilastatin / Q000009:adverse effects / Q000627:therapeutic use*; D002981:Clindamycin / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000627:therapeutic use; D004927:Escherichia coli Infections / Q000188:drug therapy; D005260:Female; D006801:Humans; D015378:Imipenem / Q000009:adverse effects / Q000627:therapeutic use*; D007710:Klebsiella Infections / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013290:Streptococcal Infections / Q000188:drug therapy
D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D015377:Cilastatin; D002981:Clindamycin; D015378:Imipenem