Individualizing duration of antibiotic therapy in community-acquired pneumonia
Section snippets
Take home message
Shortening antibiotic duration according to clinical stability might not be effective in all CAP patients.
Study design
This was a multicenter, phase IV, non-inferiority, pragmatic, randomized, controlled clinical trial enrolling adult patients hospitalized because of a CAP episode in 18 centres across Italy from January 1st, 2012 to December 27th, 2014. Ethical committee approvals were obtained both at the coordinating centre (Policlinico Hospital, Milan) and at each study centre. All recruited patients provided written informed consent. The study was registered on ClinicalTrials.gov (#NCT01492387). No
Study patients
From January 1st, 2012 to December 27th, 2014, a total of 1450 patients were screened and 260 underwent randomization: 135 were assigned to the “standard” group and 125 to the “individualized” group, see Fig. 1. The follow-up period ended on March 27th, 2015. The trial was interrupted by the safety committee because of apparent inferiority of the Individualized group over the standard treatment in regard to the primary outcome. Follow-up data were available for 100% of the patients at both 30
Discussion
The present trial was interrupted because of a higher prevalence at the ITT analysis of early failure at 30 days in hospitalized CAP patients treated with an individualized duration of antibiotic therapy according to time to clinical stability in comparison with those receiving a duration of therapy dictated by the treating physician. This difference (7.4% in the standard vs. 11.2% in the individualized group) was neither statistically significant nor was exceeding the 5% pre-planned delta.
Funding
This study was supported by an unrestricted grant from the Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy. The funding source did not have any involvement in either collection, analysis and interpretation of the data, nor in the writing of the report, nor in the decision to submit the paper for publication.
Contributions
Study concept and design: SA, JR, FB. Acquisition of data: FG, ST, MC, VV, MM, MC, RP, MDF, GM, PF, LR, MD, MV, AV, ET, MB, AB, BM. Analysis and interpretation of data: SA, FB, JR, TW, GS. Drafting of the manuscript: SA, JR, FB, GS. Critical revision of the manuscript for important intellectual content: All authors. Statistical analysis: SA, TW, GS. Study supervision: FB, JR. All authors read and approved the final manuscript. The corresponding author had full access to all the data in the
Declaration of conflict of interests
All the authors declare no competing interests.
Acknowledgments
The authors would like to acknowledge the assistance of Letizia Corinna Morlacchi and Nicola Montano (Policlinico Hospital, Milan), Sandro Amaducci (San Carlo Hospital, Milan), Paula Peyrani (University of Louisville, KY, USA), Fabio Franzetti (Luigi Sacco Hospital, Milan), Paolo Rossi and Silvia Duranti (Santa Maria della Misericordia Hospital, Udine), Giulia Bonaiti, Giulia Suigo and Alberto Pesci MD (San Gerardo Hospital, Monza), Stefano Nava, Silvia Libassi and Pierluigi Viale (Sant’Orsola
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