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Procalcitonin Antibiotic Consensus Trial (ProACT)

NCT02130986 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1664

Last updated 2019-01-15

Study results available
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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).

Conditions

  • Lower Respiratory Tract Infection (LRTI)

Interventions

OTHER

Procalcitonin level

A procalcitonin (PCT) will be drawn level within one hour after randomization in the ED, and if hospitalized, 6-24 hours after the initial ED blood draw, and on Days 3, 5, and 7. Days 3, 5, and 7 blood draws for procalcitonin will only occur in hospitalized patients on antibiotics and/or at the treating physician's discretion.

OTHER

Results of procalcitonin (PCT) level to treating clinician

In the ED, we will quickly (\<1 hour goal) provide clinicians the procalcitonin result.

OTHER

Provide procalcitonin guideline to treating clinician

Procalcitonin antibiotic guideline -- Procalcitonin level (ug/L) -- Bacterial etiology -- Recommendation \< 0.1 -- Very unlikely -- Antibiotics strongly discouraged(1) 0.1 - 0.25 -- Unlikely -- Antibiotics discouraged(1) \> 0.25 - 0.5 -- Likely -- Antibiotics recommended(2) \> 0.5 -- Very likely -- Antibiotics strongly recommended(2) 1. Initial antibiotics can be considered for critical illness, Legionella pneumophilia. Procalcitonin should be evaluated in context with all findings and the total clinical status; clinical judgment always necessary. 2. For outpatients, antibiotic duration based on level (\> 0.25-0.5 ug/L:3 days; \> 0.5-1.0 ug/L:5 days; \>1.0 ug/L:7 days). Physician follow-up is recommended.

OTHER

Telephone Visit

We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • BioMérieux

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • David T Huang, MD MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-03
Primary Completion
2017-07-21
Completion
2017-07-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02130986 on ClinicalTrials.gov