Procalcitonin for Stewardship in Respiratory Infections A Stewardship Project

NCT03109106 | Completed DMC

• 1 other identifier: IRB00120126
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

Antibiotics are overused in hospitals nationwide, leading to unnecessary drug costs and adverse events. Antibiotic stewardship is now a national and international priority and regulatory authorities are mandating antibiotic stewardship programs in all hospitals. Respiratory infections account for a large percentage of antibiotic overuse. Procalcitonin has been shown to help providers significantly shorten the duration of antibiotic therapy in respiratory infections. As such, this institution seeks to evaluate the impact of PCT-guided antibiotic management on antibiotic use in subjects with acute Lower Respiratory Tract Infection (LRTI) with or without sepsis. Multiple studies have been conducted in Europe and demonstrate the safety of the PCT-guided antibiotic management in pneumonia as well as sepsis. This study will apply PCT-guided therapy to those populations in an all-US study evaluating patient outcomes along with safety and efficacy.

Conditions

LRTI

Keywords

MICU; CICU; PCT - Procalcitonin; B·R·A·H·M·S PCT sensitive Kryptor®; Antibiotic initiation; Antibiotic de-escalation

Outcome Measures

Primary Outcomes (1)

• Antibiotic Exposure

  Total and median days of antibiotic therapy by subject compared to controls

  Hospital admission through 30 days post discharge

Secondary Outcomes (4)

• Length of stay

  Hospital admission through 30 days post discharge

• Mortality

  Hospital admission through 30 days post discharge

• 30-day readmission

  30 days post discharge

• Cost per case

  Hospital admission through discharge date, evaluated at 3 months post discharge

Study Arms (2)

PCT Arm

EXPERIMENTAL

oAntibiotic management includes use of a validated PCT algorithm in addition to clinical judgment, other laboratory values, and microbiological pathogen identification. Subjects will be enrolled and data collected prospectively in 2017. Patient records will be reviewed for outcomes data and the patients will receive a phone call for outcomes assessment at 30 days post discharge.

Device: PCT Arm

Control Group

NO INTERVENTION

Patients enrolled during the control blocks will receive antibiotics for respiratory infection at the provider's discretion in keeping with current standards of care. Patient records will be reviewed for outcomes data and the patients will receive a phone call for outcomes assessment at 30 days post discharge.

Interventions

PCT Arm DEVICE

PCT-guided antibiotic therapy per study protocol

Also known as: B·R·A·H·M·S PCT sensitive KRYPTOR®

PCT Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate patients will have evidence of an acute lower respiratory tract infection (pneumonia or acute exacerbation of chronic bronchitis) as defined as follows:
• o NEW onset within past 28 days
• At least one respiratory symptom: cough, sputum production, dyspnea, tachypnea, pleuritic chest pain, wheezing
• PLUS: At least one :
• auscultation abnormality suggestive of pneumonia (rales, ronchi, egophony)
• OR a new consolidation on chest radiology consistent with pneumonia
• OR at least one sign of systemic infection: fever \>38.1 or WBC \>10,000 or \<4,000 AND provider initiating empiric antibiotics

You may not qualify if:

• \- Age \<18
• Microbiologically documented infections caused by organisms for which a prolonged duration is standard of care (i.e. Pseudomonas, Acinetobacter, Listeria, Legionella, Pneumocystis, M. tuberculosis, Non-tuberculous mycobacterium (NTM) infection, S. aureus pneumonia or cavitary pneumonia)
• Severe infections due to viruses and parasites with a risk of bacterial translocation (hemorrhagic fever, malaria)
• Infectious conditions requiring prolonged therapy: endocarditis, brain abscess, deep abscess
• Antibiotics already started 24 hours prior to initial PCT value
• Chronic localized infections (i.e. chronic osteomyelitis, mediastinitis, brain abscess)
• Severely immunocompromised patients (HIV with CD4\<200, neutropenic with absolute neutrophil count (ANC) \<500, patients on immunosuppressive therapy after solid organ transplantation or those with autoimmune disease (corticosteroids allowed but no more than 20 mg/day (prednisone equivalent) for 14 days). Cystic fibrosis
• Active IV drug abuse
• Pregnant patients
• Patients lacking capacity to consent
• Patients admitted for burn injuries
• Patients within 30 days of major intra-thoracic or intra-abdominal surgery
• Patients receiving antibiotics for a non-respiratory infection

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Will identify eligible patients and controls prospectively in 2 week alternating blocks. Study candidates enrolled during the intervention blocks will receive PCT-guided therapy. Study candidates enrolled during the control periods will receive standard care.

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 12, 2017
• Study Start: April 15, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 15, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)