PneumoniaNCT03996330
Rapid Pathogen Identification in Ventilated Patients With Pneumonia
An observational study of Pneumonia and Mechanical Ventilation Complication, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Mechanical Ventilation Complication
- What is being tested?
- taqman array card
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Feb 2018to 23 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated patients in intensive care with suspected pneumonia, from community acquired, hospital acquired and ventilator-associated sources.
Who may be able to join
- Age >18
- Mechanically ventilated
- Treating clinician clinically suspects pneumonia and is planning to undertake diagnostic bronchoscopy and lavage
Who cannot join
- Inability to gain advice from a personal or professional consultee. Where a patient has capacity, declining consent for the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambs, CB2 0QQ
About this study
Official title: The Taqman Microarray Card for Rapid Pathogen Identification in Ventilated Patients With Pneumonia
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.
Read the detailed description
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.
- Conditions
- Pneumonia, Mechanical Ventilation Complication
- Being tested
- taqman array card
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taqman array cardDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 days
Diagnostic performance compared to conventional culture
Comparison of sensitivity and negative predictive value of array card relative to conventional microbial culture
Measured: 5 days
Secondary outcomes (2)
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
Measured: 5 days
Sensitivity of PCR from blood relative to bronchoalveolar lavage PCR
Comparison of the results of detection from broncho-alveolar lavage and blood
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start5 Feb 2018
- Primary completion16 Aug 2019
- Study completion23 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, Public Health England
- Responsible party
- Principal investigator, Andrew Conway Morris, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Vilas Navapurkar, MB ChB, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996330
- Sponsor's protocol ID
- 228951
- Status last verified
- Nov 2019
- First submitted
- 20 Jun 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Taqman Microarray Card for Rapid Pathogen Identification in Ventilated Patients With Pneumonia
- ClinicalTrials.gov ID
- NCT03996330
- Acronym / sponsor ID
- 228951
- Conditions
- Pneumonia, Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge, Public Health England
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients in intensive care with suspected pneumonia, from community acquired, hospital acquired and ventilator-associated sources.
Key inclusion criteria (3 listed)
- Age >18
- Mechanically ventilated
- Treating clinician clinically suspects pneumonia and is planning to undertake diagnostic bronchoscopy and lavage
Key exclusion criteria (1 listed)
- Inability to gain advice from a personal or professional consultee. Where a patient has capacity, declining consent for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taqman array cardThe 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. | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
Number and nature of organisms detected on taq-man array and not detected by conventional culture
Time frame: 5 days
Sensitivity of PCR from blood relative to bronchoalveolar lavage PCR
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilas Navapurkar, MB ChB principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Mechanical Ventilation Complication, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to result relative to conventional microbial culture (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.