Short-course antibiotic therapy for critically ill patients treated for postoperative intra-abdominal infection: the DURAPOP randomised clinical trial

Philippe Montravers, Florence Tubach, Thomas Lescot, Benoit Veber, Marina Esposito-Farèse, Philippe Seguin, Catherine Paugam, Alain Lepape, Claude Meistelman, Joel Cousson, Antoine Tesniere, Gaetan Plantefeve, Gilles Blasco, Karim Asehnoune, Samir Jaber, Sigismond Lasocki, Herve Dupont, DURAPOP Trial Group, Philippe Montravers, Regis Bronchard, Mathieu Desmard, Herve Dupont, Melanie Levrard, Yazine Mahjoub, Sigismond Lasocki, Soizic Gergaud, Thomas Gaillard, Gaetan Plantefeve, Olivier Pajot, Gilles Blasco, Emmanuel Samain, Guillaume Besch, Sebastien Pily-Floury, Catherine Paugam, Sebastien Pease, Paer Abback, Claude Girard, Jean-Francois Payen, Marie-Christine Herault, Samir Jaber, Boris Jung, Jean-Marc Delay, Josette Gally, Claude Meistelman, Jean-François Perrier, Karim Asehnoune, Raphael Cinotti, Antoine Tesniere, Alexandre Mignon, Thomas Lescot, Nouria Belhadj-Tahar, Marc Beaussier, Alain Lepape, Vincent Piriou, Florent Wallet, Candice Tassin, Joel Cousson, Pascal Raclot, Thierry Floch, Philippe Seguin, Yoann Launey, Benoit Veber, Philippe Gouin, Thomas Clavier, Christian Auboyer, Olivier Collanges, Jean-François Georger, Philippe Montravers, Florence Tubach, Thomas Lescot, Benoit Veber, Marina Esposito-Farèse, Philippe Seguin, Catherine Paugam, Alain Lepape, Claude Meistelman, Joel Cousson, Antoine Tesniere, Gaetan Plantefeve, Gilles Blasco, Karim Asehnoune, Samir Jaber, Sigismond Lasocki, Herve Dupont, DURAPOP Trial Group, Philippe Montravers, Regis Bronchard, Mathieu Desmard, Herve Dupont, Melanie Levrard, Yazine Mahjoub, Sigismond Lasocki, Soizic Gergaud, Thomas Gaillard, Gaetan Plantefeve, Olivier Pajot, Gilles Blasco, Emmanuel Samain, Guillaume Besch, Sebastien Pily-Floury, Catherine Paugam, Sebastien Pease, Paer Abback, Claude Girard, Jean-Francois Payen, Marie-Christine Herault, Samir Jaber, Boris Jung, Jean-Marc Delay, Josette Gally, Claude Meistelman, Jean-François Perrier, Karim Asehnoune, Raphael Cinotti, Antoine Tesniere, Alexandre Mignon, Thomas Lescot, Nouria Belhadj-Tahar, Marc Beaussier, Alain Lepape, Vincent Piriou, Florent Wallet, Candice Tassin, Joel Cousson, Pascal Raclot, Thierry Floch, Philippe Seguin, Yoann Launey, Benoit Veber, Philippe Gouin, Thomas Clavier, Christian Auboyer, Olivier Collanges, Jean-François Georger

Abstract

Purpose: Shortening the duration of antibiotic therapy (ABT) is a key measure in antimicrobial stewardship. The optimal duration of ABT for treatment of postoperative intra-abdominal infections (PIAI) in critically ill patients is unknown.

Methods: A multicentre prospective randomised trial conducted in 21 French intensive care units (ICU) between May 2011 and February 2015 compared the efficacy and safety of 8-day versus 15-day antibiotic therapy in critically ill patients with PIAI. Among 410 eligible patients (adequate source control and ABT on day 0), 249 patients were randomly assigned on day 8 to either stop ABT immediately (n = 126) or to continue ABT until day 15 (n = 123). The primary endpoint was the number of antibiotic-free days between randomisation (day 8) and day 28. Secondary outcomes were death, ICU and hospital length of stay, emergence of multidrug-resistant (MDR) bacteria and reoperation rate, with 45-day follow-up.

Results: Patients treated for 8 days had a higher median number of antibiotic-free days than those treated for 15 days (15 [6-20] vs 12 [6-13] days, respectively; P < 0.0001) (Wilcoxon rank difference 4.99 days [95% CI 2.99-6.00; P < 0.0001). Equivalence was established in terms of 45-day mortality (rate difference 0.038, 95% CI - 0.013 to 0.061). Treatments did not differ in terms of ICU and hospital length of stay, emergence of MDR bacteria or reoperation rate, while subsequent drainages between day 8 and day 45 were observed following short-course ABT (P = 0.041).

Conclusion: Short-course antibiotic therapy in critically ill ICU patients with PIAI reduces antibiotic exposure. Continuation of treatment until day 15 is not associated with any clinical benefit. CLINICALTRIALS.

Gov identifier: NCT01311765.

Keywords: Antibiotic therapy; Duration of therapy; Multidrug-resistant bacteria; Peritonitis; Postoperative intra-abdominal infection.

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