NCT02130986

Procalcitonin Antibiotic Consensus Trial (ProACT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,664 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

There is a need for improved decision-making for antibiotic prescription in acute suspected infection. Infections, particularly in the early stages, can have protean manifestations, often do not manifest with "classic" signs, and clinically overlap with non-infectious conditions. However, the imperative to quickly give antibiotics for bacterial infection has led to antibiotic overuse and resistance. Strategies that combine novel diagnostics with therapeutics have improved decision-making in oncology, cardiology, and other fields. These strategies aim to identify those patients most likely to be helped or harmed by the therapeutic intervention and allow more individualized care. This approach takes diagnostics to the next level, by demanding a test not only measure well, but also that clinical care be improved by tying the test to a treatment strategy. Procalcitonin, a novel biomarker of bacterial infection, may help physicians make more appropriate antibiotic decisions. Lower respiratory tract infection (LRTI) is an ideal trial population. LRTI accounts for a large proportion of antibiotic prescription, and exemplifies the imprecise clinical phenotype of infection.However, key questions of generalizability and safety preclude widespread application.

Conditions

• Lower Respiratory Tract Infection (LRTI)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-11-03
• Primary completion: 2017-07-21
• Completion: 2017-07-21
• First posted: 2014-05-06
• Last updated: 2019-01-15
• Results posted: 2019-01-15

Locations

13 sites across 1 country: United States