Vol.53 No.S-1 July 2005

Therapeutic exploratory study of the efficacy and safety of doripenem in patients with hospital-acquired pneumonia

Atsushi Saito¹⁾, Akira Watanabe²⁾, Shigeru Itabashi³⁾, Takefumi Saito⁴⁾, Kazuhiro Yamaguchi⁵⁾, Kunihiko Yoshimura⁶⁾, Yuji Watanuki⁷⁾, Nobuki Aoki⁸⁾, Koichi Wada⁹⁾, Hiroshi Hayakawa¹⁰⁾, Yoshito Niki¹¹⁾, Hiroki Hara¹²⁾, Masayoshi Kawanishi¹³⁾, Shigeru Kohno¹⁴⁾, Takashi Shinzato¹⁾, Keizo Yamaguchi¹⁵⁾ and Jingoro Shimada¹⁶⁾

¹⁾Department of Medicine and Therapeutics, Control and Prevention of Infectious Diseases,
Faculty Medicine, University of Ryukyus, 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
²⁾Department of Respiratory Medicine, Division of Cancer Control,
Institute of Development, Aging and Cancer, Tohoku University
³⁾Department of Respiratory Diseases, Shiogama City Hospital
(Present: Department of Respiratory Diseases, South Miyagi Medical Center)
⁴⁾Department of Respiratory Tract Medicine, National East Ibaraki Hospital
⁵⁾Department of Internal Medicine, Keio University, School of Medicine
(Present: Department of Internal Medicine, Sano Kousei General Hospital)
⁶⁾Department of Respiratory Diseases, Toranomon Hospital
⁷⁾Department of Respiratory Diseases, Kanagawa Prefectural Cardiovascular and
Respiratory Diseases Center Hospital
⁸⁾Department of Internal Medicine, Shinrakuen Hospital
⁹⁾Department of Internal Medicine, Nishi-Niigata Chuo National Hospital
¹⁰⁾Department of Internal Medicine, Tenryu Hospital
¹¹⁾Division of Respiratory Diseases, Department of Internal Medicine, Kawasaki Medical School
¹²⁾Department of Internal Medicine, Kurashiki Daiichi Hospital
¹³⁾Department of Internal Medicine, Kaneda Hospital
¹⁴⁾Division of Molecular and Clinical Microbiology, Department of Microbiology and Immunology,
Nagasaki University Graduate School of Medical Sciences
¹⁵⁾Department of Microbiology, Toho University School of Medicine
¹⁶⁾St. Marianna University School of Medicine

Abstract

We conducted a therapeutic exploratory study to evaluate the efficacy and safety of doripenem (DRPM), a new carbapenem antibiotic for injection, in 18 patients aged 44 to 95 years, with hospital-acquired pneumonia.Of these 18 were evaluated for DRPM efficacy and divided by dose as follows: 10 at 500 mg b.i.d., 3 at 500 mg t.i.d., 1 at 1,000 mg b.i.d., and 1 at a starting dose of 500 mg b.i.d. followed by 250 mg b.i.d. (downward titration based on improvement in symptoms and patient age).
In all 1 of 18, DRPM was effective and clinical efficacy was evidenced as expected before the start of treatment.
For safety, nonlaboratory adverse drug reactions were observed in only 1 case, pseudomembranous colitis. Laboratory adverse drug reactions were observed in 5, most in abnormal liver function tests.
These results show that DRPM is useful for treating patients with hospital-acquired pneumonia.

Key word

doripenem, hospital-acquired pneumonia, clinical evaluation

Received

January 24, 2005

Accepted

February 24, 2005

Jpn. J. Chemother. 53 (S-1): 205-215, 2005