title: A PROspective study on the Usage patterns of Doripenem in the Asia-Pacific region (PROUD study).
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].
authors.affiliation: Department of Medicine, Hospital Raja Perempuan Zainab II, 15000 Kota Bharu, Kelantan, Malaysia. Electronic address: mahiranmustafa@hotmail.com.
authors.forename: Mahiran
authors.initials: M
authors.lastname: Mustafa
authors.affiliation: Adult Intensive Care Unit, Queen Mary Hospital, University of Hong Kong, 102 Pokfulam Road, Hong Kong.
authors.forename: Wai Ming
authors.initials: WM
authors.lastname: Chan
authors.affiliation: Department of Medicine, ID Unit and Department of Medicine, Hospital Sungai Buloh, Selangor 47000, Malaysia.
authors.forename: Christopher
authors.initials: C
authors.lastname: Lee
authors.affiliation: Department of Anesthesiology, Dr Cipto Mangunkusumo Hospital, Diponegoro St No. 71, Kenari Village, Senen, Central Jakarta City 10430, Indonesia.
authors.forename: Eddy
authors.initials: E
authors.lastname: Harijanto
authors.affiliation: Department of Respiratory and Critical Care Medicine, Singapore General Hospital, Outram Road, Singapore 169608, Singapore.
authors.forename: Chian Min
authors.initials: CM
authors.lastname: Loo
authors.affiliation: Intensive Care Unit, National Hospital for Tropical Diseases, Giai Phong Street, Hanoi, Vietnam.
authors.forename: Nguyen
authors.initials: N
authors.lastname: Van Kinh
authors.affiliation: Emergency Department, Bach Mai Hospital, 78 Duong Giai Phong, Phuong Mai, Dong Da, Hanoi, Vietnam.
authors.forename: Nguyen Dat
authors.initials: ND
authors.lastname: Anh
authors.affiliation: Janssen Pharmaceutica, A Division of Johnson & Johnson Pte Ltd., Edison Road, Barrio Ibayo, Parañaque City 1700, Philippines.
authors.forename: Jemelyn
authors.initials: J
authors.lastname: Garcia
mesh_terms: D000151:Acinetobacter Infections / Q000188:drug therapy; D040981:Acinetobacter baumannii / Q000187:drug effects / Q000472:pathogenicity; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D001208:Asia; D015780:Carbapenems / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D000077726:Doripenem; D004926:Escherichia coli / Q000187:drug effects / Q000472:pathogenicity; D004927:Escherichia coli Infections / Q000188:drug therapy; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D059413:Intraabdominal Infections / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality; D007710:Klebsiella Infections / Q000188:drug therapy; D007711:Klebsiella pneumoniae / Q000187:drug effects / Q000472:pathogenicity; D008297:Male; D008875:Middle Aged; D053717:Pneumonia, Ventilator-Associated / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality; D011446:Prospective Studies; D011552:Pseudomonas Infections / Q000188:drug therapy; D011550:Pseudomonas aeruginosa / Q000187:drug effects / Q000472:pathogenicity; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D015780:Carbapenems; D000077726:Doripenem
keywords: Asia-Pacific; Doripenem; Medical resource utilisation