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NCT Number: NCT02130986

Procalcitonin Antibiotic Consensus Trial (ProACT)

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).

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Key information

Conditions

Lower Respiratory Tract Infection (LRTI) Bronchial Diseases Bronchitis Chronic Disease Community-Acquired Infections Community-Acquired Pneumonia Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years old
  • A primary clinical diagnosis in the ED of acute LRTI (< 28 days duration)
  • Clinician willing to consider procalcitonin in antibiotic decision-making

Exclusion criteria

  • Systemic antibiotics before ED presentation (All prophylactic antibiotic regimens, OR received >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

Treatment and study plan

Procalcitonin level

Other

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 names: PCT level

Results of procalcitonin (PCT) level to treating clinician

Other

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

Provide procalcitonin guideline to treating clinician

Other

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)

  • 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.
  • 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.

Telephone Visit

Other

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

Primary outcomes

  1. Total Antibiotic Exposure Days

    Time frame: 30 days

    Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30.

  2. Number of Participants With Any Adverse Outcome

    Time frame: 30 days

    Primary Safety Outcome - Combined endpoint of adverse outcomes (death, endotracheal intubation, vasopressors, renal failure, lung abscess/empyema, pneumonia in non-CAP patient, and hospital readmissions) that could be attributable to withholding antibiotics in lower respiratory tract infection (LRTI).

    Number is based on the number of participants that experienced any adverse outcome.

Secondary outcomes

  1. Antibiotic Prescription in Emergency Department(ED)

    Time frame: While in the ED or before ED discharge (majority patients < 1 day)

    Antibiotic prescription in the ED includes post-randomization receipt of antibiotics in ED and provision of an antibiotic prescription for patients at the time of discharge from the ED.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • BioMérieux
  • National Institute of General Medical Sciences (NIGMS)

Registry information

Acronym: ProACT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 6, 2014
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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