Rapid Pathogen Identification in Ventilated Patients With Pneumonia

NCT03996330 | Completed

• 1 other identifier: 228951
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pneumonia, a serious infection of the lungs, is a common reason for Intensive Care Unit (ICU) admission. It may also develop as a significant complication of being on a mechanical ventilator. Although the clinical diagnosis is generally straight-forward to make, determining which organism is causing the infection (pathogen) presents a much greater challenge. Existing detection of pathogens relies on growing the organism under specific conditions in a microbiology laboratory. This process is slow, typically taking 48 to 72 hours, and is influenced by factors such as presence of antibiotics and the ease with which specific organisms can be grown. Conventional microbiology may only be positive less than 40% of cases of pneumonia and this means that patients are often treated with 'best guess' antibiotics. These antibiotics are generally broad spectrum, and risk the development of antibiotic resistance. Equally, organisms which are less commonly seen may not be covered by the initial antibiotic selection and may only be started once this organism is grown after 48 to 72 hours leading to delays in appropriate treatment. The aim of this study is to evaluate the performance of a new form of diagnostic test, using detection of pathogens by gene analysis rather than relying on growth. The investigators believe that this approach will be more rapid and more sensitive, and therefore likely to translate into more rapid and appropriate use of antibiotics.

Conditions

Pneumonia; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (2)

• Time to result relative to conventional microbial culture

  Comparison of the time to result returned to clinicians between the taqman array card and conventional microbial culture

  5 days

• Diagnostic performance compared to conventional culture

  Comparison of sensitivity and negative predictive value of array card relative to conventional microbial culture

  5 days

Secondary Outcomes (2)

• Number and nature of organisms detected on taq-man array and not detected by conventional culture

  5 days

• Sensitivity of PCR from blood relative to bronchoalveolar lavage PCR

  24 hours

Interventions

taqman array card DIAGNOSTIC_TEST

The array card contains multiple PCR reactions for microbial pathogens, extracted microbial nuclear material from lavage or blood is run on the card to detect pathogen specific sequences by polymerase chain reaction.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients in intensive care with suspected pneumonia, from community acquired, hospital acquired and ventilator-associated sources.

You may qualify if:

• Age \>18
• Mechanically ventilated
• Treating clinician clinically suspects pneumonia and is planning to undertake diagnostic bronchoscopy and lavage

You may not qualify if:

• Inability to gain advice from a personal or professional consultee. Where a patient has capacity, declining consent for the study.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• University of Cambridge: collaborator
• Public Health England: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambs, CB2 0QQ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

broncho-alveolar lavage, plasma

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Vilas Navapurkar, MB ChB

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Associate and Honorary Consultant

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: February 5, 2018
• Primary Completion: August 16, 2019
• Study Completion: August 23, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)