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

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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.

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Acknowledgements

We would like to thank all physicians and nurses from all study sites for their help and support; and Isabelle Hoffmann, Ferial Toumi, Cyndie Nilusmas and Nadia Ettalhaoui (Clinical Research Unit, CHU Bichat-Claude Bernard) for their assistance in monitoring and study management.

Clinical investigators of the DURAPOP Trial Group (named with permission): CHU Bichat-Claude Bernard, Paris: Philippe Montravers MD, PhD; Regis Bronchard MD; Mathieu Desmard MD, PhD; CHU Amiens, Amiens: Herve Dupont MD, PhD; Melanie Levrard MD, Yazine Mahjoub MD, PhD; CHU Angers, Angers: Sigismond lasocki MD, PhD; Soizic Gergaud MD, Thomas Gaillard MD; CH Victor Dupouy, Argenteuil: Gaetan Plantefeve MD; Olivier Pajot MD; CHU Besançon, Besançon: Gilles Blasco MD; Emmanuel Samain MD, PhD; Guillaume Besch MD; Sebastien Pily-Floury MD, PhD; CHU Beaujon, Clichy: Catherine Paugam MD, PhD; Sebastien Pease MD, Paer Abback MD; CHU Dijon, Dijon: Claude Girard MD, PhD; CHU Grenoble, Grenoble: Jean-Francois Payen MD, PhD; Marie-Christine Herault MD; CHU Montpellier, Montpellier: Samir Jaber MD, PhD; Boris Jung MD, PhD; Jean-Marc Delay MD; CH Mulhouse, Mulhouse: Josette Gally MD; CHU Brabois, Nancy: Claude Meistelman MD, PhD; Jean-François Perrier MD; CHU Nantes, Nantes: Karim Asehnoune MD, PhD; Raphael Cinotti MD; CHU Cochin, Paris: Antoine Tesniere MD, PhD; Alexandre Mignon MD, PhD; CHU St Antoine, Paris: Thomas Lescot MD, PhD; Nouria Belhadj-Tahar MD; Marc Beaussier MD, PhD; CHU Lyon Sud, Pierre Bénite: Alain Lepape MD; Vincent Piriou MD, PhD; Florent Wallet MD; Candice Tassin MD; CHU Reims, Reims: Joel Cousson MD; Pascal Raclot MD; Thierry Floch MD; CHU Rennes, Rennes: Philippe Seguin MD, PhD; Yoann Launey MD, PhD; CHU Rouen, Rouen: Benoit Veber MD, PhD; Philippe Gouin MD; Thomas Clavier MD; CHU St-Etienne, St-Etienne: Christian Auboyer MD, PhD; CHRU Strasbourg, Strasbourg: Olivier Collanges MD, PhD; CH Intercommunal Villeneuve-St-George, Villeneuve-St-George: Jean-François Georger MD.

Funding

This work was supported by the Programme Hospitalier de Recherche Clinique (PHRC) National, 2009 (AOM 09024), funded by the French Ministry of Health. The sponsor was the Direction de la Recherche Clinique de l’Assistance Publique des Hôpitaux de Paris (France). Funding/Support and Role of Funder/Sponsor. The manuscript was prepared, reviewed and approved by the authors with no intervention from the sponsor, who also did not influence the decision to submit the manuscript for publication.

Author information

Authors and Affiliations

  1. Anaesthesiology and Critical Care Medicine, Bichat-Claude Bernard University Hospital, HUPNSV, AP-HP, INSERM, UMR 1152, Paris Diderot Sorbonne Cite University, Paris, France

    Philippe Montravers

  2. Département de Biostatistique, Santé Publique et Information Médicale (BIOSPIM), Hôpital Pitié-Salpêtrière, AP-HP, INSERM, UMR 1123, ECEVE, CIC-EC 1425, Sorbonne Universités, UPMC Univ Paris 06, 75013, Paris, France

    Florence Tubach

  3. Department of Anaesthesiology and Critical Care Medicine, St Antoine Hospital, APHP, Sorbonne Universites, UPMC Univ Paris 06, Paris, France

    Thomas Lescot

  4. Pole Anesthésie-Réanimation-SAMU, Rouen University Hospital, Rouen, France

    Benoit Veber

  5. INSERM CIC-EC 1425, Unité de Recherche Clinique, HUPNVS, CHU Bichat-Claude Bernard, APHP, Paris, France

    Marina Esposito-Farèse

  6. Department of Anaesthesiology and Surgical Intensive Care Medicine, CHU Rennes, Rennes, France

    Philippe Seguin

  7. Department of Anaesthesiology and Surgical Intensive Care Medicine, CHU Beaujon, Clichy, Paris Diderot Sorbonne Cite University, Paris, France

    Catherine Paugam

  8. Intensive Care Unit, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre Bénite, France

    Alain Lepape

  9. Service d’Anesthésie Réanimation, CHU Brabois, Nancy, France

    Claude Meistelman

  10. Pôle Anesthésie-Réanimation, CHU Reims, Reims, France

    Joel Cousson

  11. Surgical Intensive Care Unit, CHU Cochin, Paris Descartes University, Paris, France

    Antoine Tesniere

  12. Réanimation Polyvalente, CH Victor Dupouy, Argenteuil, France

    Gaetan Plantefeve

  13. Service d’Anesthésie Réanimation Chirurgicale, CHU Besancon, Besançon, France

    Gilles Blasco

  14. Service d’Anesthésie et Réanimation Chirurgicale, Hotel Dieu, CHU Nantes, Nantes, France

    Karim Asehnoune

  15. Service d’Anesthésie Réanimation, Hopital St Eloi, CHU Montpellier, Montpellier, France

    Samir Jaber

  16. Département d’Anesthésie Réanimation, CHU Angers, L’UBL, Université d’Angers, Angers, France

    Sigismond Lasocki

  17. Critical Care Medicine Department, Amiens University Hospital, INSERM U1088, University of Picardy Jules Verne, Amiens, France

    Herve Dupont

  18. Département d’Anesthésie-Réanimation, CHU Bichat Claude Bernard, 48 rue Henri Huchard, 75018, Paris, France

    Philippe Montravers

Authors
  1. Philippe Montravers
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  2. Florence Tubach
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  3. Thomas Lescot
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Consortia

For the 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

Corresponding author

Correspondence to Philippe Montravers.

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Conflicts of interest

Dr. Montravers reports personal fees and non-financial support from Astellas, AstraZeneca, Basilea, Bayer, Cubist, Menarini, MSD, Parexel, Pfizer, Tetraphase and The Medicines Company unrelated to the submitted work. Dr. Lescot reports grants, personal fees and non-financial support from Baxter, personal fees and non-financial support from Fresenius and personal fees from MSD unrelated to the submitted work. Dr. Paugam reports personal fees from MSD, Astellas and Baxter-Gambro unrelated to the submitted work. Dr. Lepape reports personal fees from Biomerieux unrelated to the submitted work. Dr. Blasco reports personal fees and non-financial support from Baxter, Astellas, Pfizer, MSD and Gilead unrelated to the submitted work. Dr. Asehnoune reports personal fees from LFB, Fresenius and Baxter unrelated to the submitted work. Dr. Jaber reports personal fees from Drager, Hamilton, Maquet and Fisher-Paykel unrelated to the submitted work. Dr. Lasocki reports research grants from Vifor Pharma and grants from LFB and Astellas unrelated to the submitted work. Dr. Dupont reports personal fees from Astellas, Pfizer, Gilead, Astrazeneca, Novartis, Merck, Cubist and and Paratek unrelated to the submitted work. No other disclosures were reported.

Additional information

DURAPOP Trial Group Investigators are listed in the Acknowledgements section.

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Montravers, P., Tubach, F., Lescot, T. et al. Short-course antibiotic therapy for critically ill patients treated for postoperative intra-abdominal infection: the DURAPOP randomised clinical trial. Intensive Care Med 44, 300–310 (2018). https://doi.org/10.1007/s00134-018-5088-x

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  • DOI: https://doi.org/10.1007/s00134-018-5088-x

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