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Antimicrobial Agents and Chemotherapy, August 2000, p. 2028-2033, Vol. 44, No. 8
Departments of Surgical
ICU1 and Internal
Medicine,2 University Hospital Bichat, and
Department of Medical and Surgical ICU, Saint Joseph
Hospital,3 Paris, France
Received 13 January 2000/Returned for modification 28 February
2000/Accepted 1 May 2000
In a randomized trial conducted in 35 centers, we compared the
clinical efficacy and safety of piperacillin plus tazobactam (TAZ)
alone (monotherapy [MT]) versus those of TAZ combined with amikacin
(AMK) (combined therapy [CT]) for the treatment of severe generalized
peritonitis (SGP). Primary analysis consisted of blind assessment by an
independent committee of the failure rate 30 days after the end of
treatment in the modified intent-to-treat (ITT) analysis (mITT)
population. Of the 241 patients with suspected SGP randomized into the
study, 227 were eligible for ITT analysis, including 204 (99 in the MT
group and 105 in the CT group) with confirmed SGP (mITT population). A
total of 159 patients were eligible for per-protocol (PP) analysis. The
clinical failure rates were equivalent in the mITT and PP populations
(MT versus CT): 56 versus 52%, (odds ratio [OR] 0.87, 90%
confidence interval [CI] = 0.6 to 1.27) for mITT and 49 versus 49%
(OR = 1.03, 90% CI = 0.67 to 1.59) for PP analysis.
Mortality rates (ITT population, 19%; PP population, 21%) and overall
adverse event rates (ITT population, 55%; PP population, 54%) were
also similar. Six patients (three in MT group and three in the CT
group) developed acute renal failure. In conclusion, the addition of
AMK to TAZ does not seem to be necessary for the treatment of SGP, even
after adjustment for the simplified acute physiology score (SAPS II) and type of SGP.
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.
Monotherapy with a Broad-Spectrum Beta-Lactam Is as Effective
as Its Combination with an Aminoglycoside in Treatment of Severe
Generalized Peritonitis: a Multicenter Randomized Controlled
Trial
for The Severe Generalized
Peritonitis Study Group
*
Corresponding author. Mailing address:
Département d'Anesthésie Réanimation
Chirurgicale, CHU Bichat Claude Bernard, 46 rue Henri Huchard, 75018 Paris, France. Phone: (33) 140258118. Fax: (33) 140258869. E-mail:
aphp{at}hdupont.claranet.fr.
The members of the Severe Generalized Peritonitis Study Group are
listed in the appendix.
Antimicrobial Agents and Chemotherapy, August 2000, p. 2028-2033, Vol. 44, No. 8
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.
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