1. A PROspective study on the Usage patterns of Doripenem in the Asia-Pacific region (PROUD study).
- Author
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Mustafa M, Chan WM, Lee C, Harijanto E, Loo CM, Van Kinh N, Anh ND, and Garcia J
- Subjects
- Acinetobacter Infections drug therapy, Acinetobacter baumannii drug effects, Acinetobacter baumannii pathogenicity, Adolescent, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents adverse effects, Anti-Bacterial Agents blood, Asia, Carbapenems adverse effects, Carbapenems blood, Doripenem, Escherichia coli drug effects, Escherichia coli pathogenicity, Escherichia coli Infections drug therapy, Female, Humans, Intensive Care Units, Intraabdominal Infections microbiology, Intraabdominal Infections mortality, Klebsiella Infections drug therapy, Klebsiella pneumoniae drug effects, Klebsiella pneumoniae pathogenicity, Male, Middle Aged, Pneumonia, Ventilator-Associated microbiology, Pneumonia, Ventilator-Associated mortality, Prospective Studies, Pseudomonas Infections drug therapy, Pseudomonas aeruginosa drug effects, Pseudomonas aeruginosa pathogenicity, Treatment Outcome, Urinary Tract Infections microbiology, Urinary Tract Infections mortality, Young Adult, Anti-Bacterial Agents therapeutic use, Carbapenems therapeutic use, Intraabdominal Infections drug therapy, Pneumonia, Ventilator-Associated drug therapy, Urinary Tract Infections drug therapy
- Abstract
Doripenem is approved in the Asia-Pacific (APAC) region for treating nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP), complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs). Clinical usage of doripenem (500mg intravenously, infused over 1h or 4h every 8h for 5-14 days) in APAC was evaluated in a prospective, open-label, non-comparative, multicentre study of inpatients (≥18 years) with NP, VAP, cIAI or cUTI. A total of 216 [intention-to-treat (ITT)] patients received doripenem: 53 NP (24.5%); 77 VAP (35.6%); 67 cIAI (31.0%); and 19 cUTI (8.8%). Doripenem MIC90 values for Pseudomonas aeruginosa, Acinetobacter baumannii, Escherichia coli and Klebsiella pneumoniae were 32, 32, 0.094 and 0.64μg/mL, respectively. Doripenem was used most commonly as monotherapy (86.6%) and as second-line therapy (62.0%). The clinical cure rate in clinically evaluable patients was 86.7% at the end of therapy (EOT) and 87.1% at test of cure (TOC) (7-14 days after EOT). In the ITT population, overall clinical cure rates were 66.2% at EOT and 56.5% at TOC. The median duration of hospital stay, intensive care unit (ICU) stay and mechanical ventilation was 20, 12 and 10 days, respectively. Of 146 discharged patients, 7 were re-admitted within 28 days of EOT; 1 VAP patient was re-admitted to the ICU. The all-cause mortality rate was 22.7% (49/216). The most common treatment-related adverse events were diarrhoea (1.4%) and vomiting (1.4%). Doripenem is a viable option for treating APAC patients with NP, VAP, cIAI or cUTI. [ClinicalTrials.gov: NCT 00986102]., (Copyright © 2014 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.)
- Published
- 2014
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