In an open, prospective clinical trial, we evaluated the safety and efficacy of
apalcillin in the treatment of complicated
urinary tract infection. 21 hospitalized adult patients received
apalcillin 2 g IV Q8-12 h for 5-17 days. There were 8 upper tract and 13 lower tract
infections. Of 25 functional or anatomic abnormalities of the GU tract among these patients, 9 (36%) were corrected during the study period. Effectiveness of
apalcillin was determined by clinical and bacteriologic response. 16 (76.2%) patients had clinical cures, 4 (19.8%) had clinical improvement, and 1 (4.8%) had clinical failure. Based on 26 pretreatment isolates, there were 16 (61.5%) bacteriologic cures and 10 (38.5%) failures. Failures were due to 6 (23.1%) relapses, 2 (7.7%)
superinfections, and 2 (7.7%) relapses with
superinfection. Adverse reactions were mild, transient, and did not require discontinuation of treatment.
Apalcillin appears to be a safe, although marginally effective single agent
antibiotic for the treatment of complicated
urinary tract infections.