Vol.53 No.S-1 July 2005
A study of doripenem efficacy and safety in internal medicine
1)Department of Medicine and Therapeutics, Control and Prevention of Infectious Diseases, Faculty of Medicine,
University of Ryukyus, 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
2)St. Marianna University School of Medicine
3)Department of Internal Medicine (Department of Infection Control), The Jikei University
4)Tokyo Metropolitan Geriatric Medical Center
Abstract
We conducted a late phase II study of doripenem (DRPM), a new carbapenem antibiotic for injection, in internal medicine.
1. Clinical efficacy
DRPM was administered at a dose of 250 mg b.i.d., 250 mg t.i.d., or 500 mg b.i.d. for 3 to 14 days in patients with chronic respiratory tract infection, pneumonia, pulmonary suppuration, pyothorax, peritonsillar abscess, and cholecystitis. Overall efficacy was 87.6% (92/105). By disease, efficacy for patients with secondary infections associated with chronic respiratory disease was 93.1% (27/29) and for those with pneumonia, etc., 84.9% (62/73). A clinical efficacy evaluation of "effective" or "highly effective" was obtained in two patients with acute upper respiratory tract infection and in one with biliary tract infection.
2. Bacteriological effect
Bacterial eradication was observed in all 36 patients in whom changes in bacterial count from the baseline were investigated. Bacterial eradication was 100.0%.
3. Safety
Nonlaboratory adverse drug reactions occurred in two of 108 patients (1.9%) and laboratory adverse drug reactions in 32 of 106 patients (30.2%).
These results suggest that DRPM at a dose of 250 mg b.i.d., 250 mg t.i.d., or 500 mg b.i.d. has sufficient therapeutic effect on patients with infection in internal medicine.
Key word
doripenem, respiratory tract infection, peritonsillar abscess, cholecystitis, clinical evaluation
Received
January 11, 2005
Accepted
March 17, 2005
Jpn. J. Chemother. 53 (S-1): 157-168, 2005
