PneumoniaDEFINENCT02736097
Drug Resistance Factors In Healthcare-associated Pneumonia
An observational study of Pneumonia and Critical Illness, run by Critical Care Pharmacotherapy Trials Network at 30 sites in 2 countries.
Trial summary
Recently clinical guidelines categorize pneumonia in to three types: community, healthcare-associated, and hospital-acquired. Much of the existing research to describe the epidemiology of pneumonia in critically ill patients comes from single-center studies or from retrospective database analyses, which limit… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Pneumonia, Critical Illness
- How many people
- 679 participants
- Where
- 30 sitesin 2 countries
- Study dates
- Nov 2016to 28 Feb 2017
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to an intensive care unit requiring anti-infective therapy for the traetment of pneumonia.
Who may be able to join
- Age ≥ 18 years old
- ICU admission
- Empiric or directed anti-infective treatment for pneumonia for ≥ 5 days
Who cannot join
- Patient stay in ICU for < 24 hours
- Patient transfer to the ICU from a hospital floor following prescription for anti-infective therapy in the previous 24 hours of ICU admission
- Diagnosis of cystic fibrosis or bronchiectasis
- Fungal pneumonia
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States29 sites
Seton Healthcare Family
Austin, Texas, 78701
Brigham and Women's Hospital
Boston, Massachusetts, 02116
Massachusetts General Hospital
Boston, Massachusetts, 02116
Mercy Medical Center
Canton, Ohio, 44708
Roper St. Francis Healthcare
Charleston, South Carolina, 29401
University of Chicago Medical Center
Chicago, Illinois, 60037
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic - Cleveland
Cleveland, Ohio, 44195
Detroit Medical Center
Detroit, Michigan, 48201
Spectrum Health
Grand Rapids, Michigan, 49503
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Hartford Healthcare
Hartford, Connecticut, 06102
Memorial Hermann Healthcare System
Houston, Texas, 77030
Roudebush - Indianapolis Veterans Administration Hospital
Indianapolis, Indiana, 46202
University of Florida - Jacksonville Hospital
Jacksonville, Florida, 32209
Northeast Regional Medical Center
Kirksville, Missouri, 63501
Lakes Regional General Healthcare
Laconia, New Hampshire, 03246
University of Kentucky Healthcare - Chandler Medical Center
Lexington, Kentucky, 40506
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Wisconsin Hospital
Madison, Wisconsin, 53792
Medical College of Wisconsin/ Froedtert Hospital
Milwaukee, Wisconsin
University of Minnesota - Fairview Health Services
Minneapolis, Minnesota, 55454
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
University of Rochester Medical Center
Rochester, New York, 14642
Beaumont Health System
Royal Oak, Michigan, 48073
Memorial University Medical Center
Savannah, Georgia, 31401
Cleveland Clinic - Florida
Weston, Florida, 33331
Saudi Arabia1 site
Ministry of of National Guard-Health Affaires
Riyahd, 1515
About this study
Official title: A Multicenter Study to Evaluate Predictive Factors for Multidrug Resistant Healthcare Associated Pneumonia in Critically Ill Patients
Recently clinical guidelines categorize pneumonia in to three types: community, healthcare-associated, and hospital-acquired. Much of the existing research to describe the epidemiology of pneumonia in critically ill patients comes from single-center studies or from retrospective database analyses, which limit generalizability and lead to over-prescription of broad-spectrum antibacterial agents. This will be a prospective, multicenter epidemiological study to characterize pneumonia epidemiology in critically ill adult patients.
Read the detailed description
Pneumonia is one of the leading causes of death in the United States and is associated with significant costs to the healthcare system. Recent treatment guidelines describe a new subtype of pneumonia, healthcare-associated pneumonia (HCAP), to identify those patients who present to a hospital from the community and are thought to be at greater risk for developing pneumonia due to multidrug resistant organisms (MDRO).
The HCAP categorization scheme is intended to improve the prescription of initial appropriate empiric antibacterial agents and minimize the morbidity and mortality associated with inappropriate empiric selection.However, one of the chief criticisms of the guideline recommendations is that the criteria used to define HCAP is overly broad, which may result in greater use of broad-spectrum antibiotics.
The prevailing notion is that many patients in the community will be at the lowest risk for experiencing MDR pneumonia and can be treated with a less broad anti-infective regimen. Patients with increasing exposure to the healthcare system will receive initial anti-infective therapy that is more broad in an effort to target MDROs. The investigator group believes that it is not simply exposure to the healthcare system that predicts the incidence of MDR pneumonia (i.e., criteria for HCAP), but rather, the "intensity" of exposure to the healthcare system that is predictive of MDR pneumonia. The aim of this study is to identify risk factors for MDR HCAP pneumonia in critically ill patients. .
- Conditions
- Pneumonia, Critical Illness
- Medical subject headings
- Pneumonia, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of multidrug resistant pneumonia pathogen
Measured: 30 days
Secondary outcomes (1)
Incidence of pneumonia subtypes
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- 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
- 679 participants (actual)
Sponsor and investigators
- Lead sponsor
- Critical Care Pharmacotherapy Trials Network
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas
- Responsible party
- Principal investigator, Ishaq Lat, Critical Care Pharmacotherapy Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736097
- Sponsor's protocol ID
- 15071001
- Acronym
- DEFINE
- Status last verified
- Jul 2017
- First submitted
- 8 Apr 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lat I, Daley MJ, Shewale A, Pangrazzi MH, Hammond D, Olsen KM; DEFINE study group and the Discovery Research Network. A Multicenter, Prospective, Observational Study to Determine Predictive Factors for Multidrug-Resistant Pneumonia in Critically Ill Adults: The DEFINE Study. Pharmacotherapy. 2019 Mar;39(3):253-260. doi: 10.1002/phar.2171. Epub 2018 Oct 3.
PubMed 30101412
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate Predictive Factors for Multidrug Resistant Healthcare Associated Pneumonia in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02736097
- Acronym / sponsor ID
- DEFINE / 15071001
- Conditions
- Pneumonia, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 679 participants (actual)
- Lead sponsor
- Critical Care Pharmacotherapy Trials NetworkUniversity, hospital or other
- Collaborators
- University of Arkansas
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 13 Apr 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.
Recently clinical guidelines categorize pneumonia in to three types: community, healthcare-associated, and hospital-acquired. Much of the existing research to describe the epidemiology of pneumonia in critically ill patients comes from single-center studies or from retrospective database analyses, which limit generalizability and lead to over-prescription of broad-spectrum antibacterial agents. This will be a prospective, multicenter epidemiological study to characterize pneumonia epidemiology in critically ill adult patients.
Detailed description
Pneumonia is one of the leading causes of death in the United States and is associated with significant costs to the healthcare system. Recent treatment guidelines describe a new subtype of pneumonia, healthcare-associated pneumonia (HCAP), to identify those patients who present to a hospital from the community and are thought to be at greater risk for developing pneumonia due to multidrug resistant organisms (MDRO).
The HCAP categorization scheme is intended to improve the prescription of initial appropriate empiric antibacterial agents and minimize the morbidity and mortality associated with inappropriate empiric selection.However, one of the chief criticisms of the guideline recommendations is that the criteria used to define HCAP is overly broad, which may result in greater use of broad-spectrum antibiotics.
The prevailing notion is that many patients in the community will be at the lowest risk for experiencing MDR pneumonia and can be treated with a less broad anti-infective regimen. Patients with increasing exposure to the healthcare system will receive initial anti-infective therapy that is more broad in an effort to target MDROs. The investigator group believes that it is not simply exposure to the healthcare system that predicts the incidence of MDR pneumonia (i.e., criteria for HCAP), but rather, the "intensity" of exposure to the healthcare system that is predictive of MDR pneumonia. The aim of this study is to identify risk factors for MDR HCAP pneumonia in critically ill patients. .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to an intensive care unit requiring anti-infective therapy for the traetment of pneumonia.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- ICU admission
- Empiric or directed anti-infective treatment for pneumonia for ≥ 5 days
Key exclusion criteria (4 listed)
- Patient stay in ICU for < 24 hours
- Patient transfer to the ICU from a hospital floor following prescription for anti-infective therapy in the previous 24 hours of ICU admission
- Diagnosis of cystic fibrosis or bronchiectasis
- Fungal pneumonia
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
Incidence of multidrug resistant pneumonia pathogen
Time frame: 30 days
1 secondary outcome
Incidence of pneumonia subtypes
Time frame: 30 days
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 1 Aug 2017.
- Derived from this study: PubMed 30101412Lat I, Daley MJ, Shewale A, Pangrazzi MH, Hammond D, Olsen KM; DEFINE study group and the Discovery Research Network. A Multicenter, Prospective, Observational Study to Determine Predictive Factors for Multidrug-Resistant Pneumonia in Critically Ill Adults: The DEFINE Study. Pharmacotherapy. 2019 Mar;39(3):253-260. doi: 10.1002/phar.2171. Epub 2018 Oct 3.
- Individual participant dataSharing planned: No
Related trials for Pneumonia
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Critical Illness, run by Critical Care Pharmacotherapy Trials Network at 30 sites in 2 countries.
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 3 inclusion and 4 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Saudi Arabia. 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?
Incidence of multidrug resistant pneumonia pathogen (time frame: 30 days). 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 NCT02736097, which also lists 1 linked publication.
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 1 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.