CTTI Risk Factors for HABP/VABP Study

Completed

• Conditions: Pneumonia, Hospital-Acquired; Pneumonia, Ventilator-Associated; Pneumonia, Bacterial

• Registration Number: NCT02689531
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to better define the intensive care unit population at highest risk for developing Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP).

Detailed Description

This is a prospective, multi-center, observational study of adult patients (≥18 years old) admitted to ICUs. Generally, all patients admitted to the ICU for any indication will be considered at risk for developing HABP/VABP. A subset of the at-risk patients treated with select respiratory modalities for at least 12 hours will be considered high risk for the development of HABP/VABP, will have baseline data collected, and will be screened daily for antibiotic treatment for suspected pneumonia. Patients not meeting high-risk criteria, "other-ICU patients", will be screened twice weekly for antibiotic treatment for suspected pneumonia.

Once a high-risk subject or other-ICU patient is treated with antibiotics for either a lower respiratory tract infection (LRTI) or undifferentiated sepsis, additional clinical information will be recorded from the subject's medical record. All subjects treated with antibiotics for either indication will subsequently be screened for the development of pneumonia, as defined by the FDA draft guidance document for drug development in HABP/VABP. Subjects who meet the FDA draft guidance definition of pneumonia will have vitals and physiologic data collected and will be followed for 4 days after pneumonia is diagnosed to capture the results of any microbiologic testing and changes to initial antibiotic therapy.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-24
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2019-10
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7530

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of HABP/VABP	Through completion of the study, up to 12 months	Estimate the rate of HABP/VABP diagnosis in ICU subjects who meet the predetermined high-risk criteria.
Eligibility for typical antibacterial clinical trial	Through completion of the study, up to 12 months	Estimate the proportion of ICU subjects diagnosed with HABP/VABP who would be eligible for enrollment in a clinical trial of antibacterial therapy for HABP/VABP per FDA draft guidance on HABP/VABP

Secondary Outcome Measures

Name	Time	Method
In enrolled subjects, what factors are associated with the development of hospital acquired or ventilator associated pneumonia.	Through completion of the study, up to 12 months	Assess the risk factors, comorbid medical illnesses, and treatment exposures associated with the development of HABP/VABP in ICU subjects at high-risk for developing pneumonia using a logistic regression model with age, sex, height (cm), weight (kg), ICU type, admission source, hospital length of stay at the time of screening (calendar days), ICU length of stay at the time of screening, ICU admission diagnosis, aspiration risk, medical history, type and duration of ventilation, enteral nutrition, medications, and other therapies of interest as factors