Pneumonia, Ventilator-AssociatedPROPHETICNCT02689531
CTTI Risk Factors for HABP/VABP Study
An observational study of Pneumonia, Ventilator-Associated and Pneumonia, Bacterial, run by Duke University at 15 sites in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumonia, Ventilator-Associated, Pneumonia, Bacterial, Pneumonia, Hospital-Acquired
- How many people
- 7,530 participants
- Where
- 15 sitesUnited States
- Study dates
- Feb 2016to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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)
Show all 26Show fewer
- 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.
Who cannot join
- 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)
- Known pregnancy (current) or breastfeeding
Show all 9Show fewer
- 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)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Study site
Birmingham, Alabama
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Detroit, Michigan
Study site
Durham, North Carolina
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Rochester, New York
Study site
Royal Oak, Michigan
Study site
St Louis, Missouri
About this study
Official title: Prospective Observational Study of the Risk Factors for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
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).
Read the 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.
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia, Bacterial, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of HABP/VABP
Estimate the rate of HABP/VABP diagnosis in ICU subjects who meet the predetermined high-risk criteria.
Measured: 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
Measured: 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.
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
Measured: Through completion of the study, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trials Transformation Initiative, Food and Drug Administration (FDA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Vance G Fowler, MD, MHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689531
- Sponsor's protocol ID
- Pro00068313
- Acronym
- PROPHETIC
- Status last verified
- Oct 2019
- First submitted
- 11 Feb 2016
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Following completion of the study, the results of this research will be written up in a manuscript to be submitted to a scientific journal. The IPD and analysis dataset are available on Vivli.org.
Publications
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.
PubMed 32615191Bergin 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.
PubMed 35836748Ericson 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.
PubMed 32150005
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of the Risk Factors for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
- ClinicalTrials.gov ID
- NCT02689531
- Acronym / sponsor ID
- PROPHETIC / Pro00068313
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,530 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Clinical Trials Transformation Initiative, Food and Drug Administration (FDA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (26 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of HABP/VABP
Time frame: 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
Time frame: 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
1 secondary outcome
In enrolled subjects, what factors are associated with the development of hospital acquired or ventilator associated pneumonia.
Time frame: Through completion of the study, up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Results publication: PubMed 32615191Bergin 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.
- Results publication: PubMed 35836748Bergin 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.
- Results publication: PubMed 32150005Ericson 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.
- Individual participant dataSharing planned: Yes. Following completion of the study, the results of this research will be written up in a manuscript to be submitted to a scientific journal. The IPD and analysis dataset are available on Vivli.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vance G Fowler, MD, MHS principal investigator
Duke University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Ventilator-Associated and Pneumonia, Bacterial, run by Duke University at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of HABP/VABP (time frame: Through completion of the study, up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02689531, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.