Clinical Study for the Efficacy and Safety of Piperacillin/sulbactam (Combicin(R)) in the Treatment of Urinary Tract Infection (Phase III)

Lee, Kkot Sil; Chang, Kyung Hee; Kim, Young Keun; Kim, Myung Soo; Choi, Jun Yong; Kim, Chang Oh; Huh, Ae Jung; Yeom, Joon Sup; Chung, Doo Ryeon; Chung, Jin Won; Woo, Jun Hee; Kim, June Myung

Abstract

BACKGROUND: Combicin(R) is a new product of beta- lactam and beta-lactamase inhibitor combination which has antibacterial activity against aerobic and anaerobic bacteria, comprised of piperacillin and sulbactam. A phase III randomized clinical trial of Combicin(R) was done to evaluate and compare the efficacy and safety of piperacillin/sulbactam (Combicin(R)) with piperacillin in the treatment of urinary tract infection.
METHODS
A total of 128 adult patients with acute urinary tract infection were enrolled and randomized into one of the two treatment groups during the period from August 1997 to September 1999 in Severance Hospital and Asan Medical Center, Seoul, Korea. Sixty-five patients were excluded in the analysis according to the exclusion criteria, and the rest 63 patients (3 men, 60 women) were eligible for the study. Clinical and bacteriologic responses were evaluated at entry and during the study period. Adverse effects were monitored by daily examination of the patients and periodic evaluations of laboratory findings. Statistical analyses were done by Chi-square test, Fisher's exact test, and Student t-test.
RESULTS
Symptoms and signs such as fever, pyuria, dysuria, frequency, tenesmus, and costovertebral angle tenderness showed improvement in both group. Most commonly isolated microorganism was E. coli. The bacteriological eradication was found in 96.7% of the Combicin(R)-treated patients and in 90.9% of the piperacillin-treated patients. Adverse drug reactions in Combicin(R)-treated patients and piperacillin-treated patients occurred in 3.33% (2/60) and 5.88% (4/68) of the patients, respectively. Adverse events included liver function test elevation, drug fever, rash, indigestion, leukopenia, and nausea. Combicin(R) was well tolerated and side effects were negligible.
CONCLUSION
Combicin(R) is safe and effective in the treatment of urinary tract infections.