Procalcitonin Antibiotic Consensus Trial (ProACT)

University of Pittsburgh

Status: Completed

Conditions: Lower Respiratory Tract Infection (LRTI)

Treatments: Other: Procalcitonin level; Other: Provide procalcitonin guideline to treating clinician; Other: Telephone Visit; Other: Results of procalcitonin (PCT) level to treating clinician

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02130986

1R01GM101197 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,664 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,664 participants in 2 patient groups

Procalcitonin (PCT) group

Experimental group

Description:

Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30

Treatment:

Other: Telephone Visit

Other: Provide procalcitonin guideline to treating clinician

Other: Results of procalcitonin (PCT) level to treating clinician

Other: Procalcitonin level

Usual Care group

Active Comparator group

Description:

Telephone Visit at Day 15 and Day 30

Treatment:

Other: Telephone Visit