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N/A N=1,664 Randomized Single-blind Treatment

Procalcitonin Antibiotic Consensus Trial (ProACT)

Lower Respiratory Tract Infection (LRTI)

Enrolled (actual)
1,664
Serious AEs
1.4%
Results posted
Jan 2019
Primary outcome: Primary: Total Antibiotic Exposure Days — 4.2; 4.3 days — p=0.87

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Procalcitonin level (Other); Results of procalcitonin (PCT) level to treating clinician (Other); Provide procalcitonin guideline to treating clinician (Other); Telephone Visit (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Pittsburgh
Primary completion
Jul 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Antibiotic Exposure Days
4.2; 4.3 0.87
PRIMARY
Number of Participants With Any Adverse Outcome
96; 109 <0.001 sig
SECONDARY
Antibiotic Prescription in Emergency Department(ED)
282; 321

Summary

The ProACT study is a 5 year, multicenter study that will test the effect of implementation of a novel procalcitonin guideline on antibiotic use and adverse outcomes in Emergency Department (ED) patients with Lower Respiratory Tract Infection (LRTI).

Eligibility Criteria

Inclusion Criteria

  • ≥ 18 years old
  • A primary clinical diagnosis in the ED of acute LRTI ( 1 dose within 72 hours prior to ED presentation)
  • Current vasopressor use
  • Mechanical ventilation (via endotracheal tube)
  • Known severe immunosuppression
  • Accompanying non-respiratory infections
  • Known lung abscess or empyema
  • Chronic dialysis
  • Metastatic cancer
  • Surgery in the past 7 days (excluding minor surgery such as skin biopsy)
  • Incarcerated or homeless
  • Enrolled in ProACT in the past 30 days
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02130986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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