• Antonio Anzueto, Oriol Sibila, Grant Waterer, Richard Wunderink, Marcos Restrepo, Paola Faverio, Alejandro Arango, and Eric Mortensen.
• Chest. 2014 Mar 1;145(3 Suppl):151A.

Session TitleRespiratory Infections PostersSESSION TYPE: Poster PresentationsPRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PMPURPOSE: Azithromycin (AZ) is a macrolide that has shown increased survival in patients with community-acquired pneumonia and bacteremic pneumococcal pneumonia. Immunomodulatory properties are claimed to be associated with the beneficial effects of macrolides. However, limited data are available about the clinical efficacy in patients with severe sepsis. Our aim was to assess the efficacy of AZ in addition to standard of care (SOC) therapy compared to SOC antimicrobial therapy in a pilot randomized controlled trial (RCT) in critically ill patients with severe sepsis.MethodsThis is an open-label RCT that compared AZ/SOC vs. SOC in critically ill patients with severe sepsis with at least one organ failure according to the ACCP guidelines. The study was performed at two tertiary teaching hospitals. The Per-Protocol (PP) interventions included patients that received at least 3 days of AZ (500 mg daily of 5 days of therapy) vs. appropriate SOC for at least 3 days. Exclusion criteria were: 1) immunosuppressed, 2) allergy to macrolides, 3) QTc prolongation and the use of concomitant medications that may prolong the QTc. The primary outcome was 28-day mortality and the secondary outcomes were short- (ICU and in-hospital mortality), long-term mortality (at 180-days and 365-days) and length of stay (LOS) in the ICU and in the hospital.ResultsWe enrolled 47 subjects in the PP analysis that completed at least 3-days of antimicrobial treatment (n=22 AZ/SOC and n=25 SOC). The primary outcome of 28-day mortality was similar in both groups (AZ/SOC, n=3 [14%] vs. SOC, n=2 [8%], p=0.5). The secondary outcomes were ICU mortality (AZ/SOC, n=2 [9%] vs. SOC n=1 [4%], p=0.5), in-hospital mortality (AZ/SOC, n=2 [9%] vs. SOC n=2 [8%], p=0.9), 180-day mortality (AZ/SOC, n=4 [18%] vs. SOC, n=5 [21%], p=0.5), and 360-day mortality (AZ/SOC n=5 [24%] vs. SOC n=9 [39%], p=0.2). The ICU LOS was AZ/SOC median (IQR) 7 (4-16) vs. 8 (4-13) days, p=.5; and hospital LOS AZA/SOC median (IQR) 19 (7-26) vs. 18 (13-28) days, p=.9; respectively.ConclusionsIn this pilot open label RCT the use of AZ in addition to SOC was not associated with better survival or shorter LOS in the PP analysis of severe septic patients who received at least 3-days of antimicrobial therapy.Clinical ImplicationsFurther RCTs should assess the clinical efficacy of AZ in patients with severe sepsis or septic shock.DisclosureMarcos Restrepo: Grant monies (from sources other than industry): NIH/NHLBI K23HL096054 The following authors have nothing to disclose: Paola Faverio, Alejandro Arango, Oriol Sibila, Eric Mortensen, Grant Waterer, Richard Wunderink, Antonio AnzuetoNo Product/Research Disclosure Information.

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