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OpenTrials
Completed

NCT Number: NCT02736097

Drug Resistance Factors In Healthcare-associated Pneumonia

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ministry of of National Guard-Health Affaires, Riyahd, Saudi Arabia

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About this study

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. .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of multidrug resistant pneumonia pathogen

    Time frame: 30 days

Secondary outcomes

  1. Incidence of pneumonia subtypes

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Critical Care Pharmacotherapy Trials Network

Other

Collaborators

  • University of Arkansas

Registry information

Official study title

A Multicenter Study to Evaluate Predictive Factors for Multidrug Resistant Healthcare Associated Pneumonia in Critically Ill Patients

Acronym: DEFINE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2016
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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