Drug Resistance Factors In Healthcare-associated Pneumonia (DEFINE)

• ClinicalTrials.gov Identifier: NCT02736097
• Recruitment Status: Completed
• First Posted: April 13, 2016
• Last Update Posted: August 1, 2017
• Sponsor: Critical Care Pharmacotherapy Trials Network
• Collaborator: University of Arkansas
• Information provided by (Responsible Party): Ishaq Lat, Critical Care Pharmacotherapy Trials Network

Tracking Information

• First Submitted Date: April 8, 2016
• First Posted Date: April 13, 2016
• Last Update Posted Date: August 1, 2017
• Actual Study Start Date: November 2016
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 12, 2016): Incidence of multidrug resistant pneumonia pathogen [ Time Frame: 30 days ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02736097 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: April 12, 2016): Incidence of pneumonia subtypes [ Time Frame: 30 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Drug Resistance Factors In Healthcare-associated Pneumonia
• Official Title: A Multicenter Study to Evaluate Predictive Factors for Multidrug Resistant Healthcare Associated Pneumonia in Critically Ill Patients
• Brief 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 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients admitted to an intensive care unit requiring anti-infective therapy for the traetment of pneumonia.

Condition

• Pneumonia
• Critical Illness

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 29, 2017): 679
• Original Estimated Enrollment (submitted: April 12, 2016): 600
• Actual Study Completion Date: February 28, 2017
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age ≥ 18 years old
• ICU admission
• Empiric or directed anti-infective treatment for pneumonia for ≥ 5 days

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Saudi Arabia, United States

Administrative Information

• NCT Number: NCT02736097
• Other Study ID Numbers: 15071001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Ishaq Lat, Critical Care Pharmacotherapy Trials Network
• Study Sponsor: Critical Care Pharmacotherapy Trials Network
• Collaborators: University of Arkansas
• Investigators: Not Provided
• PRS Account: Critical Care Pharmacotherapy Trials Network
• Verification Date: July 2017