Vol.58 No.6 November 2010
A clinical phase III study of pazufloxacin in patients with sepsis
1)Department of Infection Control and Prevention, Kobe University Hospital, 7-5-2 Kusunoki, Chuo-ku, Kobe, Hyogo, Japan
2)Department of Infectious Disease, Kyorin University School of Medicine
3)Department of Pharmacology, Jikei University School of Medicine
(Present: Department of Infectious Diseases and Infection Control, Jikei University School of Medicine)
4)Department of Dermatology, Teikyo University
5)Department of Infectious Disease, Tokyo Women's Medical University
Abstract
The clinical efficacy and safety of pazufloxacin(PZFX), an injectable fluoroqunolone antimicrobial, administered at a dose of 1,000 mg twice daily, were evaluated for 27 subjects with sepsis in an open uncontrolled clinical study.
Of the 27, all of whom underwent full analysis set(FAS), 6 had positive blood culture (per protocol set, PPS). Clinical efficacy rate at the end of treatment was 100% (6/6 subjects), as was eradication rate. The infection focus in 3 of subjects was the urinary tract, in 2 the respiratory tract, and in 1 the iliopsoas muscle/lumbar vertebla disk. Causative organisms were 3 Escherichia coli, 2 Streptococcus pneumoniae(PSSP), and 1 Staphylococcus epidermidis. Clinical efficacy was excellent in 11, moderate in 9, poor in 3, and unevaluable in 4. Overall efficacy rate was 87.0% (20/23 subjects).
101 adverse events were seen in 25 of the 27 (92.6%). 59 adverse drug reactions were seen in 21 of the 27 (77.8%). Adverse drug reactions observed in over 5% of subjects included increased AST in 25.5% (7/27 subjects), injection site pain in 18.5% (5/27 subjects), increased ALT in 18.5% (5/27 subjects), increased γ-GTP in 11.5% (3/26 subjects), increased ALP in 11.1% (3/27 subjects), diarrhea in 7.4% (2/27 subjects), and increased bilirubin in 7.4% (2/27 subjects). All adverse drug reactions were mild or moderate and previously known adverse events for PZFX.
We concluded that at 1,000 mg twice daily is useful in those suffering from sepsis.
Key word
pazufloxacin, high dose, sepsis
Received
August 2, 2010
Accepted
September 10, 2010
Jpn. J. Chemother. 58 (6): 650-663, 2010
