Study to Determine Quicker Methods of Diagnosing Pneumonia Caused by a Breathing Machine in Critically Ill Patients

Ventilator Acquired Pneumonia Clinical Trial

Official title:

Rapid Bacterial Identification and Antibiotic Resistance Testing in Critically Ill Adults at Risk for Ventilator Acquired Pneumonia (VAP).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938002
• Other study ID #: 09-0321
• Secondary ID: UL1RR025780
• Status: Completed
• Start date: July 2009
• Est. completion date: September 19, 2019

Study information

• Verified date: December 2019
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Critically ill patients on a breathing machine are at risk of developing a type of pneumonia called Ventilator Acquired Pneumonia (VAP). The purpose of this study is to determine if regular lung rinses sent for microbiological testing can reduce the time to diagnose VAP. The study also plans to test the accuracy and speed of a new technology, using multiplexed automated digital microscopy, to identify the germs causing the VAP.

Description:

Ventilator-associated pneumonia (VAP) is a common, life-threatening hospital-acquired infectious complication of prolonged mechanical ventilation (MV). Despite aggressive efforts to prevent VAP, rates remain high because clinical diagnosis is imprecise and microbiological diagnosis is frequently delayed. Diagnosis of VAP depends on clinical signs as well as microbiologic evidence from Bronchioalveolar Lavage (BAL) cultures. Ordinarily, these cultures are only ordered after the patient presents with clinical signs and symptoms of VAP, which can significantly delay diagnosis and effective therapy. This research proposes to implement additional surveillance BAL cultures in order to reduce the time to diagnosis of VAP in mechanically ventilated critically ill adults. To further reduce the time to diagnosis of VAP, this research aims to test part of the BAL cultures using a novel flowcell/surface-capture device that allows direct from specimen visualization of bacteria using multiplexed automated digital microscopy (BACcel™) for rapid bacterial identification and antibiotic resistance testing. Additionally, molecular assays of the BAL sample will characterize lower respiratory tract antimicrobial peptide host-innate immune molecule and local anti-oxidant defenses in mechanically ventilated adults at risk for VAP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 19, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written, informed consent (by surrogate if unconscious or if altered mental status)

2. = 18 years old

3. Admission to a Medical Intensive care unit

4. Orally/nasally intubated, evaluable within 72 h of initial intubation

5. Expected to remain mechanically ventilated for at least 48 h after the first study procedure

Exclusion Criteria:

1. Previously documented cystic fibrosis

2. Diffuse bronchiectasis

3. Severe or massive hemoptysis

4. Presence of an advanced directive to withhold life-sustaining treatment

5. Morbid state or expected to survive less than 14 days because of an advanced co-morbid medical condition

6. Participation in a clinical trial of any unlicensed drug or device within 30 days

7. Pregnant or Nursing

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Acquired Pneumonia

Intervention

Diagnostic Test:
• Acceler8 Pheno

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	Accerl8 Technology Corporation, National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in time to diagnosis and treatment of VAP in an at risk population		30 days