Pneumonia Clinical Trial
Official title:
The Taqman Microarray Card for Rapid Pathogen Identification in Ventilated Patients With Pneumonia
NCT number | NCT03996330 |
Other study ID # | 228951 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 5, 2018 |
Est. completion date | August 23, 2019 |
Verified date | November 2019 |
Source | Cambridge University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 23, 2019 |
Est. primary completion date | August 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age >18 - Mechanically ventilated - Treating clinician clinically suspects pneumonia and is planning to undertake diagnostic bronchoscopy and lavage Exclusion Criteria: • Inability to gain advice from a personal or professional consultee. Where a patient has capacity, declining consent for the study. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge | Cambs |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust | Public Health England, University of Cambridge |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Diagnostic performance compared to conventional culture | Comparison of sensitivity and negative predictive value of array card relative to conventional microbial culture | 5 days | |
Secondary | Number and nature of organisms detected on taq-man array and not detected by conventional culture | Description of organisms detected on taq-man array and not detected by conventional culture | 5 days | |
Secondary | Sensitivity of PCR from blood relative to bronchoalveolar lavage PCR | Comparison of the results of detection from broncho-alveolar lavage and blood | 24 hours |
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