CTTI Risk Factors for HABP/VABP Study

Pneumonia, Bacterial Clinical Trial

— PROPHETIC  

Official title:

Prospective Observational Study of the Risk Factors for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689531
• Other study ID #: Pro00068313
• Status: Completed
• Start date: February 2016
• Est. completion date: February 2018

Study information

• Verified date: October 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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antibiotics for either indication will subsequently be screened for the development of pneumonia, as defined by the FDA draft guidance document for drug development in HABP/VABP. Subjects who meet the FDA draft guidance definition of pneumonia will have vitals and physiologic data collected and will be followed for 4 days after pneumonia is diagnosed to capture the results of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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7530
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria (Adult arm => 18 years old):

• Admission to participating ICU

• Hospitalized for >48 hours or admitted <7 days after discharge from an inpatient acute or chronic care facility

High-Risk Inclusion (Adult arm => 18 years old):

Treated with one or more of the following respiratory modalities for at least 12 hours, either currently or within the prior 7 days:

• Invasive mechanical ventilation

• Noninvasive ventilation (BiPAP or CPAP for any indication other than obstructive sleep apnea)

• High-flow, supplemental oxygen therapy via nasal cannula. Only include systems that using an air/oxygen blender capable of delivering a precise FiO2 level, not just a flow in LPM.

• High flow supplemental oxygen therapy delivering at least 50% FiO2 via aerosol facemask or tracheostomy collar (mask). Only include systems using an air/oxygen blender capable of delivering a precise FiO2 level, not just a flow in LPM.

• Supplemental oxygen therapy delivered via either partial or non-rebreather face mask

Other-ICU Inclusion(Adult arm => 18 years old):

All patients who meet ICU and time-frame eligibility criteria, but do not fulfill high-risk criteria, and are receiving an antibiotic for treatment of LRTI or undifferentiated sepsis.

Exclusion Criteria(Adult arm => 18 years old):

• Age <18 years old

• Pregnancy (current) or breastfeeding

• Lung cancer or another malignancy metastatic to the lungs (currently receiving treatment)

• Patient previously enrolled and treated for suspected HABP or VABP (More than CRF Part 1 was previously completed)

• Patient is on comfort measures (e.g. would not receive antibiotics)

Inclusion Criteria (Pediatric Arm: < 18 years old)

• < 18 years old

• Admission to participating ICU or intermediate care unit

• Hospitalized for >48 hours or admitted <7 days after discharge from an inpatient acute or chronic care facility Note: Children and infants with pulmonary and cardiac anomalies are eligible to participate.

High-Risk Inclusion (Pediatric Arm: < 18 years old)

Subjects =120 days old and <18 years old:

Currently treated with one or more of the following respiratory modalities for at least 24 hours:

• Invasive mechanical ventilation via endotracheal intubation

• New initiation of mechanical ventilation, BiPAP or CPAP via tracheostomy

• Noninvasive ventilation (BiPAP or CPAP for any indication other than obstructive sleep apnea)

• High-flow, supplemental oxygen therapy delivering at least 1.5LMP with 100% FiO2 via nasal cannula when delivered using an air/oxygen blender capable of delivering a precise FiO2 level, not just a flow in LPM

• High flow supplemental oxygen therapy delivering at least 50% FiO2 via aerosol facemask or tracheostomy collar (mask) when delivered using an air/oxygen blender capable of delivering a precise FiO2 level, not just a flow in LPM

• Supplemental oxygen therapy delivered via either partial or non-rebreather face mask

Subjects <120 days old:

Currently treated with mechanical ventilation via endotracheal intubation for at least 5 days

Standard-Risk Inclusion (Pediatric Arm: < 18 years old) All patients who meet pediatric eligibility criteria, but do not fulfill high-risk criteria, and are receiving an antibiotic for treatment of LRTI or undifferentiated sepsis.

Exclusion Criteria (Pediatric Arm: < 18 years old)

• Known pregnancy (current) or breastfeeding

• Lung cancer or another malignancy metastatic to the lungs (currently receiving treatment)

• Patient previously enrolled and treated for suspected HABP or VABP (More than Pediatric CRF Part 1 was previously completed)

• Patient is on comfort measures (e.g. would not receive antibiotics)

Related Conditions & MeSH terms

• Healthcare-Associated Pneumonia
• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Hospital-Acquired
• Pneumonia, Ventilator-Associated

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Clinical Trials Transformation Initiative, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bergin SP, Calvert SB, Farley J, Sun JL, Chiswell K, Dieperink W, Kluytmans J, Lopez-Delgado JC, Leon-Lopez R, Zervos MJ, Kollef MH, Sims M, Kabchi BA, Rubin D, Santiago J, Natarajan M, Tenaerts P, Fowler VG, Holland TL, Bonten MJ, Hullegie SJ. PROPHETIC — View Citation

Bergin SP, Coles A, Calvert SB, Farley J, Powers JH, Zervos MJ, Sims M, Kollef MH, Durkin MJ, Kabchi BA, Donnelly HK, Bardossy AC, Greenshields C, Rubin D, Sun JL, Chiswell K, Santiago J, Gu P, Tenaerts P, Fowler VG Jr, Holland TL. PROPHETIC: Prospective — View Citation

Ericson JE, McGuire J, Michaels MG, Schwarz A, Frenck R, Deville JG, Agarwal S, Bressler AM, Gao J, Spears T, Benjamin DK Jr, Smith PB, Bradley JS; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee and the Clinical Trials T — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of HABP/VABP	Estimate the rate of HABP/VABP diagnosis in ICU subjects who meet the predetermined high-risk criteria.	Through completion of the study, up to 12 months
Primary	Eligibility for typical antibacterial clinical trial	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	Through completion of the study, up to 12 months
Secondary	In enrolled subjects, what factors are associated with the development of hospital acquired or ventilator associated pneumonia.	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	Through completion of the study, up to 12 months