CTTI Risk Factors for HABP/VABP Study

NCT02689531 | Completed

• 1 other identifier: Pro00068313
• Study Type: observational
• Target: 7,530
• Locations: 1 country
• Sites: 15

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).

Conditions

Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Pneumonia, Hospital-Acquired

Outcome Measures

Primary Outcomes (2)

• 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

• 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with HABP/VABP who would be eligible for enrollment in a clinical trial of antibacterial therapy for HABP/VABP per FDA draft guidance on HABP/VABP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 Outcomes (1)

• 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

Study Arms (4)

High-Risk (Adult =>18 years old)

Treated with one or more of the following respiratory modalities for at least 12 continuous 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/Standard Risk

Patients do not fulfill high-risk criteria, but, are receiving an antibiotic for treatment of lower respiratory tract infection or undifferentiated sepsis.

High-Risk (Pediatric ≥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

High-Risk (Pediatric <120 days old)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All ICU patients at participating sites hospitalized for \>48 hours or admitted \<7 days after discharge from an inpatient acute or chronic care facility

You may qualify if:

• Admission to participating ICU
• Hospitalized for \>48 hours or admitted \<7 days after discharge from an inpatient acute or chronic care facility
• 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
• 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.

You may not qualify if:

• 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)
• \< 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.
• 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

Sponsors & Collaborators

• Duke University: lead
• Clinical Trials Transformation Initiative: collaborator
• Food and Drug Administration (FDA): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (15)

Unknown Facility

Birmingham, Alabama, United States

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Los Angeles, California, United States

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Chicago, Illinois, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Detroit, Michigan, United States

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Royal Oak, Michigan, United States

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St Louis, Missouri, United States

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Rochester, New York, United States

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Durham, North Carolina, United States

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Cleveland, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Unknown Facility

Nashville, Tennessee, United States

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Related Publications (3)

• 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 Identification of Pneumonia in Hospitalized Patients in the ICU. Chest. 2020 Dec;158(6):2370-2380. doi: 10.1016/j.chest.2020.06.034. Epub 2020 Jun 29.

  PMID: 32615191 RESULT

• 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 EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts. Open Forum Infect Dis. 2022 May 9;9(7):ofac231. doi: 10.1093/ofid/ofac231. eCollection 2022 Jul.

  PMID: 35836748 RESULT

• 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 Transformation Initiative. Hospital-acquired Pneumonia and Ventilator-associated Pneumonia in Children: A Prospective Natural History and Case-Control Study. Pediatr Infect Dis J. 2020 Aug;39(8):658-664. doi: 10.1097/INF.0000000000002642.

  PMID: 32150005 RESULT

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Vance G Fowler, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 24, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: June 15, 2023

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The IPD and analysis dataset are available on Vivli.org
• Access Criteria: Complete data request process at vivli.org.

Locations

US (15)