Study of safety and efficacy of doripenem in patients with sepsis and infective endocarditis

Accession number;05A0663336
Title;Study of safety and efficacy of doripenem in patients with sepsis and infective endocarditis
Author; SAITO ATSUSHI (Ryukyudai Daigakuin'igakukenkyuka Kansenbyotaiseigyogaku Bunshibyotaikansenshogakubun'ya) KAMIDONO SADAO (Kobe Univ., School of Medicine, JPN) YOKOYAMA TAKASHI (Hiroshima Univ. Medical Hospital, JPN) YAMAGUCHI KEIZO (Toho Univ., School of Med.) SHIMADA JINGORO (St. Marianna Univ. School of Medicine, JPN)
Journal Title;Japanese Journal of Chemotherapy
Journal Code:F0608A
ISSN:1340-7007
VOL.53;NO.Supplement 1;PAGE.332-340(2005)
Figure&Table&Reference;TBL.6, REF.15
Pub. Country;Japan
Language;Japanese
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 .GAMMA.-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. (author abst.)