Rapid Pathogen Identification in Ventilated Patients With Pneumonia
|ClinicalTrials.gov Identifier: NCT03996330|
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : November 19, 2019
|Condition or disease||Intervention/treatment|
|Pneumonia Mechanical Ventilation Complication||Diagnostic Test: taqman array card|
Pneumonia is a common cause of admission to the intensive care unit, and can also develop as a secondary complication of mechanical ventilation. The diagnosis of pneumonia relies on a combination of clinical and radiographic signs, demonstrating an inflammatory infiltrate to the lung parenchyma combined with evidence of infection. The treatment is appropriate antibiotics, together with supportive care as required by the patient's condition.
The selection of appropriate antibiotics presents a significant challenge, as between 60 and 70% of cases of pneumonia do not yield positive results on microbial cultures. This is the case in both community acquired and hospital acquired pneumonia. It can take up to 72 hours for results of conventional cultures to be returned, and these two aspects mean that pneumonia is commonly treated with empiric broad spectrum antibiotics. Rapid, sensitive tests for microbes could lead to a significant reduction in antibiotic use 1 and use of narrower spectrum agents, which will reduce the selective pressure for anti-microbial resistant organisms.
The investigators on this study have previously shown that a multiplex polymerase chain reactions targeting respiratory pathogens can enhance the detection of such organisms in patients with community-acquired pneumonia and immuno-compromised patients developing pneumonia. The use of a TaqMan microarray card allows for large multiplexing of the PCR reactions, which would allow a single card to target a wide range of potential respiratory pathogens including both community-acquired and hospital-acquired organisms.
The aim of this study is to evaluate a new taqMan multiplex PCR array card, which targets common community and hospital-acquired respiratory pathogens. The investigators anticipate that the results from this card will be available more rapidly than conventional culture. The investigators also aim to evaluate the diagnostic performance of the card, compared to conventional cultures, and validate its use in the population of ventilated patients in intensive care. In addition, conventional cultures of blood have a significantly lower yield in pneumonia that respiratory samples, however as they are considerably less invasive to obtain than broncho-alveolar lavage it would be advantageous if a highly sensitive assay for bacteria could detect relevant respiratory pathogen DNA in the blood. Therefore alongside the testing of respiratory samples, the investigators will assess the ability of the taqMan array to detect organisms in a contemporaneously obtained blood sample.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||The Taqman Microarray Card for Rapid Pathogen Identification in Ventilated Patients With Pneumonia|
|Actual Study Start Date :||February 5, 2018|
|Actual Primary Completion Date :||August 16, 2019|
|Actual Study Completion Date :||August 23, 2019|
- Diagnostic Test: taqman array card
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.
- Time to result relative to conventional microbial culture [ Time Frame: 5 days ]Comparison of the time to result returned to clinicians between the taqman array card and conventional microbial culture
- Diagnostic performance compared to conventional culture [ Time Frame: 5 days ]Comparison of sensitivity and negative predictive value of array card relative to conventional microbial culture
- Number and nature of organisms detected on taq-man array and not detected by conventional culture [ Time Frame: 5 days ]Description of organisms detected on taq-man array and not detected by conventional culture
- Sensitivity of PCR from blood relative to bronchoalveolar lavage PCR [ Time Frame: 24 hours ]Comparison of the results of detection from broncho-alveolar lavage and blood
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996330
|Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, Cambs, United Kingdom, CB2 0QQ|
|Principal Investigator:||Vilas Navapurkar, MB ChB||Cambridge University Hospitals NHS Foundation Trust|