Vol.53 No.S-1 July 2005
Study of safety and efficacy of doripenem in patients with sepsis and infective endocarditis
1)Department of Medicine and Therapeutics, Control and Prevention of Infectious Diseases, Faculty of Medicine,
University of the Ryukyus, 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
2)Department of Urology, Kobe University, School of Medicine
3)Department of General Medical Treatment, Hiroshima University Hospital (Present: Aki Municipal Hospital)
4)Department of Microbiology, Toho University School of Medicine
5)St. Marianna University School of Medicine
Abstract
In this study, doripenem (DRPM) was administered to 11 patients (2: infective endocarditis, 9: sepsis). Of the 9 patients with sepsis, the primary focus was infection arising from urology in 7 and surgery in 2. DRPM was administered for 3-14 days for sepsis and 28 days for infective endocarditis. Based on the health of patients, the investigator or subinvestigator chose the number of doses per day considered appropriate. Clinical findings improved as expected and in all cases, DRPM was effective in treatment. The causative organism and identified in 5 cases: in sepsis, 1 case of Klebsiella pneumoniae and 2 cases of Escherichia coli, and in infective endocarditis, 1 each of Streptococcus sanguis and Streptococcus vestibularis. After completion of administration, all causative organisms had been eradicated.
For safety, nonlaboratory adverse drug reactions were observed in 2 patients: constipation in one and vomiting and diarrhea in the other. Laboratory adverse drug reactions were observed in 3, i.e., increased ALT (GPT) in 1, increased ALT (GPT) and γ-GTP in 1, and eosinophilia in 1.
These results show that DRPM is sufficiently therapeutic and that a dose of 500 mg b.i.d. or t.i.d. is appropriate for sepsis and infective endocarditis.
Key word
doripenem, sepsis, endocarditis, clinical evaluation
Received
January 11, 2005
Accepted
March 1, 2005
Jpn. J. Chemother. 53 (S-1): 332-340, 2005
