Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
7530 participants
OBSERVATIONAL
2016-02-29
2018-02-28
Brief Summary
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Detailed Description
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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antibiotics for either indication will subsequently be screened for the development of pneumonia, as defined by the FDA draft guidance document for drug development in HABP/VABP. Subjects who meet the FDA draft guidance definition of pneumonia will have vitals and physiologic data collected and will be followed for 4 days after pneumonia is diagnosed to capture the results of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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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.
No interventions assigned to this group
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
No interventions assigned to this group
High-Risk (Pediatric <120 days old)
Currently treated with mechanical ventilation via endotracheal intubation for at least 5 days
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
* \< 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
* 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)
* 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)
ALL
No
Sponsors
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Clinical Trials Transformation Initiative
OTHER
Food and Drug Administration (FDA)
FED
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Vance G Fowler, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Royal Oak, Michigan, United States
St Louis, Missouri, United States
Rochester, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Study Documents
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Document Type: Individual Participant Data Set
View DocumentOther Identifiers
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Pro00068313
Identifier Type: -
Identifier Source: org_study_id
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