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|Title: ||Azithromycin during Acute Chronic Obstructive Pulmonary Disease Exacerbations Requiring Hospitalization (BACE) A Multicenter, Randomized, Double-Blind, Placebo-controlled Trial|
|Authors: ||Vermeersch, Kristina|
Demedts, Ingel K.
Verleden, Geert M.
Brusselle, Guy G.
|Issue Date: ||2019|
|Publisher: ||AMER THORACIC SOC|
|Citation: ||AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 200(7), p. 857-868|
|Abstract: ||Rationale: Azithromycin prevents acute exacerbations of chronic obstructive pulmonary disease (AECOPDs); however, its value in the treatment of an AECOPD requiring hospitalization remains to be defined. Objectives: We investigated whether a 3-month intervention with low-dose azithromycin could decrease treatment failure (TF) when initiated at hospital admission and added to standard care. Methods: In an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial, patients who had been hospitalized for an AECOPD and had a smoking history of pack >= 10 years and one or more exacerbations in the previous year were randomized (1:1) within 48 hours of hospital admission to azithromycin or placebo. The study drug (500 mg/d for 3 d) was administered on top of a standardized acute treatment of systemic corticosteroids and antibiotics, and subsequently continued for 3 months (250 mg/2 d). The patients were followed for 6 months thereafter. Time-to-first-event analyses evaluated the TF rate within 3 months as a novel primary endpoint in the intention-to-treat population, with TF defined as the composite of treatment intensification with systemic corticosteroids and/or antibiotics, a step-up in hospital care or readmission for respiratory reasons, or allcause mortality. Measurements and Main Results: A total of 301 patients were randomized to azithromycin (n = 147) or placebo (n = 154). The TF rate within 3 months was 49% in the azithromycin group and 60% in the placebo group (hazard ratio, 073; 95% confidence interval, 0.53-1.01; P = 0.0526). Treatment intensification, step-up in hospital care, and mortality rates within 3 months were 47% versus 60% (P = 0.0272), 13% versus 28% (P = 0.0024), and 2% versus 4% (P = 0.5075) in the azithromycin and placebo groups, respectively. Clinical benefits were lost 6 months after withdrawal. Conclusions: Three months of azithromycin for an infectious AECOPD requiring hospitalization may significantly reduce TF during the highest-risk period. Prolonged treatment seems to be necessary to maintain clinical benefits.|
|Notes: ||[Vermeersch, Kristina; Everaerts, Stephanie; Verleden, Geert M.; Troosters, Thierry; Janssens, Wim] Katholieke Univ Leuven, Lab Resp Dis, Dept Chron Dis Metab & Ageing, Leuven, Belgium. [Belmans, Ann; Bogaerts, Kris] Katholieke Univ Leuven, I BioStat, Leuven, Belgium. [Troosters, Thierry] Katholieke Univ Leuven, Dept Rehabil Sci, Fac Kinesiol & Rehabil Sci, Leuven, Belgium. [Vermeersch, Kristina; Everaerts, Stephanie; Verleden, Geert M.; Janssens, Wim] Univ Hosp Leuven, Dept Resp Dis, Leuven, Belgium. [Vandenberk, Bert; Willems, Rik] Univ Hosp Leuven, Dept Cardiol, Leuven, Belgium. [Gabrovska, Maria; Ninane, Vincent] Univ Libre Bruxelles, Ctr Hosp Univ St Pierre, Dept Pneumol, Brussels, Belgium. [Aumann, Joseph] Jessa Ziekenhuis, Dept Pneumol, Hasselt, Belgium. [Demedts, Ingel K.] AZ Delta Roeselare Menen, Dept Resp Med, Roeselare, Belgium. [Corhay, Jean-Louis] Ctr Hosp Univ, Dept Pneumol, Liege, Belgium. [Marchand, Eric] CHU UCL Namur, Dept Pneumol, Yvoir, Belgium. [Marchand, Eric] Univ Namur, Lab Resp Physiol, Fac Med, NARILIS, Namur, Belgium. [Slabbynck, Hans] ZNA Middelhe, Dept Resp Med, Antwerp, Belgium. [Haenebalcke, Christel] Acad Hosp St Jan, Dept Pneumol, Brugge Oostende, Belgium. [Haerens, Michiel] AZ Groeninge, Dept Pneumol, Kortrijk, Belgium. [Hanon, Shane] UZ Brussel, Dept Pneumol, Jette, Belgium. [Jordens, Paul] Onze Lieve Vrouw Hosp, Dept Pneumol, Aalst, Belgium. [Peche, Rudi] Ctr Hosp Univ Charleroi, Dept Pneumol, Charleroi, Belgium. [Fremault, Antoine] Grand Hop Charleroi, Dept Pneumol, Charleroi, Belgium. [Lauwerier, Tine] Imelda Ziekenhuis, Dept Pneumol, Bonheiden, Belgium. [Delporte, Anja; Brusselle, Guy G.] Ghent Univ Hosp, Dept Resp Med, Ghent, Belgium. [Belmans, Ann; Bogaerts, Kris] Univ Hasselt, Hasselt, Belgium. [Ninane, Vincent] CHU St Pierre, Brussels, Belgium. [Aumann, Joseph] Jessa Ziekenhuis, Hasselt, Belgium. [Demedts, Ingel K.] AZ Delta, Roeselare Menen, Belgium. [Slabbynck, Hans] ZNA Middelheim, Antwerp, Belgium. [Marchand, Eric] CHU UCL Namur, Yvoir, Belgium. [Haenebalcke, Christel] AZ St Jan Ziekenhuis, Brugge, Belgium. [Peche, Rudi] CHU Charleroi, Charleroi, Belgium. [Brusselle, Guy G.] UZ Gent, Ghent, Belgium. [Vincken, Walter] UZ Brussel, Brussels, Belgium. [Corhay, Jean-Louis] CHU Liege, Luik, Belgium. [Haerens, Michiel] AZ Groeninge, Kortrijk, Belgium. [Fremault, Antoine] Grand Hop Charleroi, Charleroi, Belgium. [Lauwerier, Tine] Imelda Ziekenhuis, Bonheiden, Belgium. [Debrock, Alix] St Augustinus Ziekenhuis, Antwerp, Belgium. [Lamont, Jan] Maria Middelares Ziekenhuis, Ghent, Belgium. [Tits, Geert] St Andriesziekenhuis, Tielt, Belgium. [Jordens, Paul] Onze Lieve Vrouw Hosp, Aalst, Belgium. [Delobbe, Alain] Clin Reine Astrid, Malmedy, Belgium. [Martinot, Jean-Benoit] Clin Ste Elisabeth, Namur, Belgium.|
|ISI #: ||000488777100015|
|Type: ||Journal Contribution|
|Appears in Collections: ||Research publications|
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