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Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Hospital resource utilization with doripenem versus imipenem in the treatment of ventilator-associated pneumonia.
Clinical Therapeutics 2008 April
BACKGROUND: Ventilator-associated pneumonia (VAP) is a common nosocomial infection that is associated with prolonged length of stay (LOS) and significant mortality.
OBJECTIVE: The aim of this study was to compare resource utilization with doripenem, an investigational carbapenem, versus imipenem from a hospital perspective among patients with VAP.
METHODS: This analysis was based on data from a Phase III, randomized, open-label, noninferiority study that compared clinical cure of VAP with doripenem 500 mg q8h i.v. (4-hour infusion) with imipenem 500 mg q6h (30-minute infusion) or 1000 mg q8h i.v. (1-hour infusion). Total hospital LOS, intensive care unit (ICU) LOS, and time on mechanical ventilation for doripenem and imipenem were compared in a clinical modified intent-to-treat population. P values were determined using the generalized Wilcoxon test, which compared treatments in a time-to-event analysis, censoring patients at the late follow-up visit (28-35 days after the end of i.v. therapy).
RESULTS: Patients in the doripenem and imipenem groups had similar baseline clinical characteristics. Median hospital LOS was significantly shorter with doripenem versus imipenem (22 vs 27 days; P=0.010); median time on mechanical ventilation was significantly shorter for doripenem (7 vs 10 days; P=0.034); median ICU LOSs were similar between the 2 groups (12 vs 13 days). Clinical cure and mortality rates were similar.
CONCLUSIONS: Of the 3 primary end points in this analysis, hospital LOS and time on mechanical ventilation were significantly shorter with doripenem compared with imipenem; no statistical significance was observed in ICU LOS. These findings suggest that doripenem use may be associated with an economic and clinical benefit to patients and hospitals.
OBJECTIVE: The aim of this study was to compare resource utilization with doripenem, an investigational carbapenem, versus imipenem from a hospital perspective among patients with VAP.
METHODS: This analysis was based on data from a Phase III, randomized, open-label, noninferiority study that compared clinical cure of VAP with doripenem 500 mg q8h i.v. (4-hour infusion) with imipenem 500 mg q6h (30-minute infusion) or 1000 mg q8h i.v. (1-hour infusion). Total hospital LOS, intensive care unit (ICU) LOS, and time on mechanical ventilation for doripenem and imipenem were compared in a clinical modified intent-to-treat population. P values were determined using the generalized Wilcoxon test, which compared treatments in a time-to-event analysis, censoring patients at the late follow-up visit (28-35 days after the end of i.v. therapy).
RESULTS: Patients in the doripenem and imipenem groups had similar baseline clinical characteristics. Median hospital LOS was significantly shorter with doripenem versus imipenem (22 vs 27 days; P=0.010); median time on mechanical ventilation was significantly shorter for doripenem (7 vs 10 days; P=0.034); median ICU LOSs were similar between the 2 groups (12 vs 13 days). Clinical cure and mortality rates were similar.
CONCLUSIONS: Of the 3 primary end points in this analysis, hospital LOS and time on mechanical ventilation were significantly shorter with doripenem compared with imipenem; no statistical significance was observed in ICU LOS. These findings suggest that doripenem use may be associated with an economic and clinical benefit to patients and hospitals.
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