PLoS ONE (Jan 2015)

Antibiotic treatment of severe exacerbations of chronic obstructive pulmonary disease with procalcitonin: a randomized noninferiority trial.

  • Alessia Verduri,
  • Fabrizio Luppi,
  • Roberto D'Amico,
  • Sara Balduzzi,
  • Roberto Vicini,
  • Anna Liverani,
  • Valentina Ruggieri,
  • Mario Plebani,
  • Maria Pia Foschino Barbaro,
  • Antonio Spanevello,
  • Giorgio Walter Canonica,
  • Alberto Papi,
  • Leonardo Michele Fabbri,
  • Bianca Beghè,
  • FARM58J2XH Study Group

DOI
https://doi.org/10.1371/journal.pone.0118241
Journal volume & issue
Vol. 10, no. 3
p. e0118241

Abstract

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The duration of antibiotic treatment of exacerbations of COPD (ECOPD) is controversial. Serum procalcitonin (PCT) is a biomarker of bacterial infection used to identify the cause of ECOPD.We investigated whether a PCT-guided plan would allow a shorter duration of antibiotic treatment in patients with severe ECOPD. For this multicenter, randomized, non-inferiority trial, we enrolled 184 patients hospitalized with ECOPD from 18 hospitals in Italy. Patients were assigned to receive antibiotics for 10 days (standard group) or for either 3 or 10 days (PCT group). The primary outcome was the rate of ECOPD at 6 months. Having planned to recruit 400 patients, we randomized only 183: 93 in the PCT group and 90 in the standard group. Thus, the completed study was underpowered. The ECOPD rate at 6 months between PCT-guided and standard antibiotic treatment was not significant (% difference, 4.04; 90% confidence interval [CI], -7.23 to 15.31), but the CI included the non-inferiority margin of 15. In the PCT-guided group, about 50% of patients were treated for 3 days, and there was no difference in primary or secondary outcomes compared to patients treated for 10 days.Although the primary and secondary clinical outcomes were no different for patients treated for 3 or 10 days in the PCT group, the conclusion that antibiotics can be safely stopped after 3 days in patients with low serum PCT cannot be substantiated statistically. Thus, the results of this study are inconclusive regarding the noninferiority of the PCT-guided plan compared to the standard antibiotic treatment. The study was funded by Agenzia Italiana del Farmaco (AIFA-FARM58J2XH). Clinical trial registered with www.clinicaltrials.gov (NCT01125098).ClinicalTrials.gov NCT01125098.