Double-blind, controlled study to evaluate safety and efficacy of doripenem and meropenem m patients with complicated urinary tract infection
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Accession number;05A0663328
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| Title;Double-blind, controlled study to evaluate safety and efficacy of doripenem and meropenem m patients with complicated urinary tract infection |
| Author;
KAMIDONO SADAO
(Kobe Univ., School of Medicine, JPN)
ARAKAWA SOICHI
(Kobe Univ., School of Medicine, JPN)
HIROSE TAKAOKI
(Hokkaidoshakaihokenbyoin Hinyokika)
KISHI HIROICHI
(Kokuritsukokusaiiryose Hinyokika)
TSUGAWA MASAYA
(Okayama Univ., Medical School, JPN)
MATSUMOTO TETSURO
(Univ. Occupational and Environmental Health, School of Medicine, Dep. Urology, JPN)
TANAKA MASATOSHI
(Kyudai I Hinyokika)
KAWAHARA MOTOSHI
(Kagoshima Univ., Fac. of Med.)
NAKASHIMA MITSUYOSHI
(Hamamatsucptken)
KATAOKA NOBUMASA
(Kobe Univ., School of Medicine, JPN)
SHIMADA JINGORO
(St. Marianna Univ. School of Medicine, JPN)
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Journal Title;Japanese Journal of Chemotherapy
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Journal Code:F0608A
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ISSN:1340-7007
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VOL.53;NO.Supplement 1;PAGE.244-259(2005)
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| Figure&Table&Reference;FIG.3, TBL.17, REF.19 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;We conducted a double-blind, controlled study to evaluate the safety and efficacy of doripenem (DRPM), a new carbapenem antibiotic for injection, in patients with complicated urinary tract infection with meropenem (MEPM) set as the control drug. Subjects were in-patients aged 20 to 79 years shown to have pyuria of at least 5 WBCs/hpf and bacteriuria of at least 10'4' CFU/ mL. DRPM was administered at 250 mg b.i.d. and MEPM at 500 mg b.i.d. for 5 consecutive days. Based on the criteria proposed by the Japanese UTI Committee, DRPM and MEPM were evaluated for efficacy. Overall efficacy was 96.1% (73/76) in the DRPM group and 88.6% (70/79) in the MEPM group, demonstrating the non inferiority of DRPM to MEPM (Pn=0.0003). The bacteriological response was 95.9% (94/98) in the DRPM group and 96.2% (101/105) in the MEPM group, demonstrating the non inferiority of DRPM to MEPM (p=0.0036). For both gram-negative and gram-positive bacteria, the bacteriological response exceeded 95% in both groups. Clinical efficacy judged by attending urologists was 93.4% (71/76) in the DRPM group and 92.4% (73/79) in the MEPM group, demonstrating the non inferiority of DRPM to MEPM (Pn=0.0098). For safety, the incidence of adverse drug reactions (symptoms) was 4.3% (4/92) in the DRPM group and 4.0% (4/101) in the MEPM group. The incidence of adverse drug reactions (abnormal laboratory findings) was 17.6% (16/91) in the DRPM group and 22.2% (22/99) in the MEPM group, with no significant difference between groups (Pe=1.0000, 0.4709). These results show that DRPM at 250 mg b.i.d. is useful for treating patients with complicated urinary tract infection, and equivalent to MEPM at 500 mg b.i.d.. (author abst.) |
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