PneumoniaCAPNORNCT04660084
Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP
A study testing Ultra-rapid molecular point-of-care testing in people with Pneumonia, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Investigators will recruit patients suspected of community-acquired pneumonia at Haukeland University Hospital, Bergen, into a pragmatic randomized controlled trial to assess if provision of ultra-rapid, high-quality accurate molecular diagnostics with direct feedback to the clinician can facilitate pathogen-directed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Ultra-rapid molecular point-of-care testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteNorway
- Study dates
- 25 Sep 2020to 21 Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- Adults (aged ≥18 years),
- Clinical diagnosis of CAP (presence of at least two clinical criteria [new/worsening cough, new/worsening expectoration of sputum, haemoptysis, new/worsening dyspnoea, pleuritic chest pain, fever, or abnormalities on chest auscultation or percussion] or one clinical criterion and radiological evidence of CAP)
- Requiring hospitalisation to a non-ICU ward
- Capacity to give informed written consent or consent provided by the patient's legally authorized representative.
Who cannot join
- Pulmonary embolism
- Lung tumor
- Cystic fibrosis
- Palliative approach
- Patients who decline to provide respiratory tract specimens
- Severe immunodeficiency
- Hospitalization for two or more days in the last 14 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP in Norway: a Pragmatic Randomised Controlled Trial
Investigators will recruit patients suspected of community-acquired pneumonia at Haukeland University Hospital, Bergen, into a pragmatic randomized controlled trial to assess if provision of ultra-rapid, high-quality accurate molecular diagnostics with direct feedback to the clinician can facilitate pathogen-directed usage of antibiotics, shorten antibiotic exposure and admission time and is safe. Additionally, transcriptional and immune marker profiling of patients will guide appropriate management through a targeted focus on the individual patient's physical capacity, nutritional status and co- morbidities. The pragmatic design of this trial together with broad inclusion criteria and a straightforward intervention would make our results generalisable to other similar centres.
Read the detailed description
The study is a pragmatic, single-blind, single-centre randomised controlled trial (RCT) where community-acquired pneumonia (CAP) patients will receive standard of care microbiological testing or standard of care microbiological testing and comprehensive ultra-rapid molecular testing (UR-MT).
Investigators will over a 3-year period (2020-2022), consecutively enroll cases of CAP admitted (~900/year) to Haukeland University Hospital (HUS, Bergen). The study will consist of representative patients admitted with CAP and thus, will potentially be generalisable to hospitalised patients with CAP in Norway. As COVID-19 cannot be distinguished clinically from other pneumonias, the study will therefore include patients with suspected CAP, including with COVID-19. Approximately 1500 CAP patients will be screened to achieve a total of 1060 (allowing for a 10% dropout rate) enrolled patients that are randomly assigned to receive standard of care microbiological testing or standard of care testing microbiological and the comprehensive ultra-rapid molecular test (UR-MT).
Inclusion criteria for the study are: adults (aged ≥18 years), with a clinical diagnosis of CAP (presence of at least two clinical criteria [new/worsening cough, new/worsening expectoration of sputum, haemoptysis, new/worsening dyspnoea, pleuritic chest pain, fever, or abnormalities on chest auscultation or percussion] or one clinical criterion and radiological evidence of CAP), requiring hospitalisation to a non-ICU ward, and with a capacity to give informed written consent or consent provided by the patient's legally authorized representative.
Exclusion criteria include: lung tumour, cystic fibrosis, a palliative approach, patients who decline to provide respiratory tract specimens, severe immunodeficiency, and hospitalization for two or more days in the last 14 days.
Based on clinical evaluation and data of admission, patients will be triaged for severity according to current risk assessment guidelines, as well as the CRB-65 score for the assessment of severity of pneumonia. Randomization of CAP patients to the two treatment arms (1:1) will be performed in blocks of size 4, 6, or, 8, occurring in random order, to ensure approximately equal allocation over the year.
The prescribed empirical therapy for each patient will be compared with what antimicrobial(s) would have been appropriate for pathogen-directed therapy, based on the UR-MT result. Appropriate pathogen-directed therapy will be determined using national guidelines recommended by the Norwegian directorate of health
- Conditions
- Pneumonia
- Being tested
- Ultra-rapid molecular point-of-care testing
- Keywords
- Microbiology, Bacteria and viruses, Rapid diagnosis, Antibiotic resistance, Diagnostic stewardship
- Medical subject headings
- Pneumonia, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-rapid molecular point-of-care testingDiagnostic test
Also called BioFire® FilmArray® Pneumonia plus platform (Biomérieux)
Ultra-rapid molecular testing (UR-MT) comprises automated detection using the new BioFire® FilmArray® Pneumonia plus platform (Biomérieux). The total turn-around time is <2 hrs.
The UR-MT is combined with standard of care, comprising:
Microbiological processing per current standard of care entails culture of respiratory tract samples according to national protocols to detect respiratory bacteria, identified using biochemical methods and/or matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF MS). Respiratory viruses are identified using real-time PCR (for metapneumovirus, rhinovirus, influenza A, influenza B, parainfluenza 1-3, RSV and SARS-CoV-2). The total turn-around time is up to 48 hrs.
| Study group | Role | What they receive |
|---|---|---|
| Ultra-rapid molecular point-of-care testing | Other | Extended and more rapid diagnostics on microbiological specimens and an active feedback to treating staff with results. Receives: Diagnostic Test: Ultra-rapid molecular point-of-care testing |
| Standard of care | No intervention | Standard collection of microbiological specimens and standard reply to treating staff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The provision of pathogen-directed treatment based on a microbiological test result deemed as clinically relevant within 48 hours of receipt of respiratory samples.
Binary outcome: yes: it was provided/no: it was not provided
Measured: "Up to 72 hours"
Time in hours from receipt of respiratory specimens to receiving pathogen-directed treatment
Quantitative outcome (measured in hours): time from receipt of respiratory specimens to provision of pathogen-directed treatment based on a microbiological test result deemed as clinically relevant or an elapse of 48 hours, whichever event came first.
Measured: "Up to 72 hours"
Secondary outcomes (12)
Duration of antibiotic use in days
Duration of antibiotic use in days
Measured: "Up to 4 weeks"
Proportion of patients receiving narrow-spectrum antibiotics within 48 hours from study inclusion
Proportion of patients receiving narrow-spectrum antibiotics within 48 hours from study inclusion
Measured: "Up to 4 weeks"
Proportion of patients receiving a single dose of antibiotics
Proportion of patients receiving a single dose of antibiotics
Measured: "Up to 1 week"
Proportion of patients receiving ≤48 h of antibiotics
Proportion of patients receiving ≤48 h of antibiotics
Measured: "Up to 1 week"
Proportion of patients receiving intravenous antibiotics
Proportion of patients receiving intravenous antibiotics
Measured: "Up to 1 week"
Duration of intravenous antibiotics in days
Duration of intravenous antibiotics in days
Measured: "Up to 4 weeks"
Proportion of cases where the UR-MT results were used to guide treatment
Proportion of cases where the UR-MT results were used to guide treatment
Measured: "Up to 1 week"
Time in days to isolation or de-isolation
Time in days to isolation or de-isolation
Measured: "Up to 2 weeks"
Duration of "door-to-needle time" in hours
Duration of "door-to-needle time" in hours
Measured: "Up to 1 week"
Length of hospital stay in days
Length of hospital stay in days
Measured: "Up to 3 months"
Proportion of 30-day readmission
Proportion of 30-day readmission
Measured: "Up to 30 days from discharge"
Proportion of 30- and 90-day and 1- and 5 year mortality
Proportion of 30- and 90-day and 1- and 5 year mortality
Measured: "Up to 1 month, 3 months, 1 and 5 years, from admission"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start25 Sep 2020
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Why it stopped: The trial was stopped earlier than planned after an ad hoc interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic, parallel-arm, single-blinded, single-centre, randomised controlled superiority trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Drammen sykehus, University of Copenhagen, Copenhagen University Hospital, Rigshospitalet, UMC Utrecht, University of Southampton, Quadram Institute Bioscience
- Responsible party
- Sponsor
- Investigators
- Harleen Grewal, MD PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660084
- Sponsor's protocol ID
- HaukelandUH_31935
- Acronym
- CAPNOR
- Status last verified
- Mar 2022
- First submitted
- 12 Nov 2020
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saghaug CS, Markussen DL, Knoop ST, Holvik BC, Serigstad S, Ulvestad E, Ritz C, Jenum S, Grewal HMS. Diagnostic accuracy of a host response test in suspected community-Acquired pneumonia during the COVID-19 era. Int J Infect Dis. 2025 Nov;160:108045. doi: 10.1016/j.ijid.2025.108045. Epub 2025 Sep 2.
PubMed 40907740Markussen DL, Wathne JS, Ritz C, van Werkhoven CH, Serigstad S, Bjorneklett RO, Ulvestad E, Knoop ST, Jenum S, Grewal HMS. Determinants of non-adherence to antibiotic treatment guidelines in hospitalized adults with suspected community-acquired pneumonia: a prospective study. Antimicrob Resist Infect Control. 2024 Nov 23;13(1):140. doi: 10.1186/s13756-024-01494-2.
PubMed 39580437Markussen DL, Serigstad S, Ritz C, Knoop ST, Ebbesen MH, Faurholt-Jepsen D, Heggelund L, van Werkhoven CH, Clark TW, Bjorneklett RO, Kommedal O, Ulvestad E, Grewal HMS. Diagnostic Stewardship in Community-Acquired Pneumonia With Syndromic Molecular Testing: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e240830. doi: 10.1001/jamanetworkopen.2024.0830.
PubMed 38446481Serigstad S, Knoop ST, Markussen DL, Ulvestad E, Bjorneklett RO, Ebbesen MH, Kommedal O, Grewal HMS. Diagnostic utility of oropharyngeal swabs as an alternative to lower respiratory tract samples for PCR-based syndromic testing in patients with community-acquired pneumonia. J Clin Microbiol. 2023 Sep 21;61(9):e0050523. doi: 10.1128/jcm.00505-23. Epub 2023 Aug 16.
PubMed 37585220Serigstad S, Ritz C, Faurholt-Jepsen D, Markussen D, Ebbesen MH, Kommedal O, Bjorneklett RO, Heggelund L, Clark TW, van Werkhoven CH, Knoop ST, Ulvestad E, Grewal HMS; CAPNOR study group. Impact of rapid molecular testing on diagnosis, treatment and management of community-acquired pneumonia in Norway: a pragmatic randomised controlled trial (CAPNOR). Trials. 2022 Aug 1;23(1):622. doi: 10.1186/s13063-022-06467-7.
PubMed 35915452
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP in Norway: a Pragmatic Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04660084
- Acronym / sponsor ID
- CAPNOR / HaukelandUH_31935
- Conditions
- Pneumonia
- Keywords
- Microbiology, Bacteria and viruses, Rapid diagnosis, Antibiotic resistance, Diagnostic stewardship
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was stopped earlier than planned after an ad hoc interim analysis
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen, Drammen sykehus, University of Copenhagen, Copenhagen University Hospital, Rigshospitalet, UMC Utrecht, University of Southampton, Quadram Institute Bioscience
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 9 Dec 2020 (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.
Investigators will recruit patients suspected of community-acquired pneumonia at Haukeland University Hospital, Bergen, into a pragmatic randomized controlled trial to assess if provision of ultra-rapid, high-quality accurate molecular diagnostics with direct feedback to the clinician can facilitate pathogen-directed usage of antibiotics, shorten antibiotic exposure and admission time and is safe. Additionally, transcriptional and immune marker profiling of patients will guide appropriate management through a targeted focus on the individual patient's physical capacity, nutritional status and co- morbidities. The pragmatic design of this trial together with broad inclusion criteria and a straightforward intervention would make our results generalisable to other similar centres.
Detailed description
The study is a pragmatic, single-blind, single-centre randomised controlled trial (RCT) where community-acquired pneumonia (CAP) patients will receive standard of care microbiological testing or standard of care microbiological testing and comprehensive ultra-rapid molecular testing (UR-MT).
Investigators will over a 3-year period (2020-2022), consecutively enroll cases of CAP admitted (~900/year) to Haukeland University Hospital (HUS, Bergen). The study will consist of representative patients admitted with CAP and thus, will potentially be generalisable to hospitalised patients with CAP in Norway. As COVID-19 cannot be distinguished clinically from other pneumonias, the study will therefore include patients with suspected CAP, including with COVID-19. Approximately 1500 CAP patients will be screened to achieve a total of 1060 (allowing for a 10% dropout rate) enrolled patients that are randomly assigned to receive standard of care microbiological testing or standard of care testing microbiological and the comprehensive ultra-rapid molecular test (UR-MT).
Inclusion criteria for the study are: adults (aged ≥18 years), with a clinical diagnosis of CAP (presence of at least two clinical criteria [new/worsening cough, new/worsening expectoration of sputum, haemoptysis, new/worsening dyspnoea, pleuritic chest pain, fever, or abnormalities on chest auscultation or percussion] or one clinical criterion and radiological evidence of CAP), requiring hospitalisation to a non-ICU ward, and with a capacity to give informed written consent or consent provided by the patient's legally authorized representative.
Exclusion criteria include: lung tumour, cystic fibrosis, a palliative approach, patients who decline to provide respiratory tract specimens, severe immunodeficiency, and hospitalization for two or more days in the last 14 days.
Based on clinical evaluation and data of admission, patients will be triaged for severity according to current risk assessment guidelines, as well as the CRB-65 score for the assessment of severity of pneumonia. Randomization of CAP patients to the two treatment arms (1:1) will be performed in blocks of size 4, 6, or, 8, occurring in random order, to ensure approximately equal allocation over the year.
The prescribed empirical therapy for each patient will be compared with what antimicrobial(s) would have been appropriate for pathogen-directed therapy, based on the UR-MT result. Appropriate pathogen-directed therapy will be determined using national guidelines recommended by the Norwegian directorate of health
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A pragmatic, parallel-arm, single-blinded, single-centre, randomised controlled superiority trial
| Arm | Type | Receives |
|---|---|---|
| Ultra-rapid molecular point-of-care testing | Other | Diagnostic Test: Ultra-rapid molecular point-of-care testingExtended and more rapid diagnostics on microbiological specimens and an active feedback to treating staff with results. |
| Standard of care | No intervention | –Standard collection of microbiological specimens and standard reply to treating staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (aged ≥18 years),
- Clinical diagnosis of CAP (presence of at least two clinical criteria [new/worsening cough, new/worsening expectoration of sputum, haemoptysis, new/worsening dyspnoea, pleuritic chest pain, fever, or abnormalities on chest auscultation or percussion] or one clinical criterion and radiological evidence of CAP)
- Requiring hospitalisation to a non-ICU ward
- Capacity to give informed written consent or consent provided by the patient's legally authorized representative.
Key exclusion criteria (7 listed)
- Pulmonary embolism
- Lung tumor
- Cystic fibrosis
- Palliative approach
- Patients who decline to provide respiratory tract specimens
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 |
|---|---|---|
| Ultra-rapid molecular point-of-care testingAlso: BioFire® FilmArray® Pneumonia plus platform (Biomérieux)Ultra-rapid molecular testing (UR-MT) comprises automated detection using the new BioFire® FilmArray® Pneumonia plus platform (Biomérieux). The total turn-around time is <2 hrs. The UR-MT is combined with standard of care, comprising: Microbiological processing per current standard of care entails culture of respiratory tract samples according to national protocols to detect respiratory bacteria, identified using biochemical methods and/or matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF MS). Respiratory viruses are identified using real-time PCR (for metapneumovirus, rhinovirus, influenza A, influenza B, parainfluenza 1-3, RSV and SARS-CoV-2). The total turn-around time is up to 48 hrs. | Diagnostic test | Ultra-rapid molecular point-of-care testing |
Primary outcome
The provision of pathogen-directed treatment based on a microbiological test result deemed as clinically relevant within 48 hours of receipt of respiratory samples.
Time frame: "Up to 72 hours"
Binary outcome: yes: it was provided/no: it was not provided
Time in hours from receipt of respiratory specimens to receiving pathogen-directed treatment
Time frame: "Up to 72 hours"
Quantitative outcome (measured in hours): time from receipt of respiratory specimens to provision of pathogen-directed treatment based on a microbiological test result deemed as clinically relevant or an elapse of 48 hours, whichever event came first.
12 secondary outcomes
Duration of antibiotic use in days
Time frame: "Up to 4 weeks"
Proportion of patients receiving narrow-spectrum antibiotics within 48 hours from study inclusion
Time frame: "Up to 4 weeks"
Proportion of patients receiving a single dose of antibiotics
Time frame: "Up to 1 week"
Proportion of patients receiving ≤48 h of antibiotics
Time frame: "Up to 1 week"
Proportion of patients receiving intravenous antibiotics
Time frame: "Up to 1 week"
Duration of intravenous antibiotics in days
Time frame: "Up to 4 weeks"
Proportion of cases where the UR-MT results were used to guide treatment
Time frame: "Up to 1 week"
Time in days to isolation or de-isolation
Time frame: "Up to 2 weeks"
Duration of "door-to-needle time" in hours
Time frame: "Up to 1 week"
Length of hospital stay in days
Time frame: "Up to 3 months"
Proportion of 30-day readmission
Time frame: "Up to 30 days from discharge"
Proportion of 30- and 90-day and 1- and 5 year mortality
Time frame: "Up to 1 month, 3 months, 1 and 5 years, from admission"
Results and safety
The study was stopped early (reason given: The trial was stopped earlier than planned after an ad hoc interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 40907740Saghaug CS, Markussen DL, Knoop ST, Holvik BC, Serigstad S, Ulvestad E, Ritz C, Jenum S, Grewal HMS. Diagnostic accuracy of a host response test in suspected community-Acquired pneumonia during the COVID-19 era. Int J Infect Dis. 2025 Nov;160:108045. doi: 10.1016/j.ijid.2025.108045. Epub 2025 Sep 2.
- Derived from this study: PubMed 39580437Markussen DL, Wathne JS, Ritz C, van Werkhoven CH, Serigstad S, Bjorneklett RO, Ulvestad E, Knoop ST, Jenum S, Grewal HMS. Determinants of non-adherence to antibiotic treatment guidelines in hospitalized adults with suspected community-acquired pneumonia: a prospective study. Antimicrob Resist Infect Control. 2024 Nov 23;13(1):140. doi: 10.1186/s13756-024-01494-2.
- Derived from this study: PubMed 38446481Markussen DL, Serigstad S, Ritz C, Knoop ST, Ebbesen MH, Faurholt-Jepsen D, Heggelund L, van Werkhoven CH, Clark TW, Bjorneklett RO, Kommedal O, Ulvestad E, Grewal HMS. Diagnostic Stewardship in Community-Acquired Pneumonia With Syndromic Molecular Testing: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e240830. doi: 10.1001/jamanetworkopen.2024.0830.
- Derived from this study: PubMed 37585220Serigstad S, Knoop ST, Markussen DL, Ulvestad E, Bjorneklett RO, Ebbesen MH, Kommedal O, Grewal HMS. Diagnostic utility of oropharyngeal swabs as an alternative to lower respiratory tract samples for PCR-based syndromic testing in patients with community-acquired pneumonia. J Clin Microbiol. 2023 Sep 21;61(9):e0050523. doi: 10.1128/jcm.00505-23. Epub 2023 Aug 16.
- Derived from this study: PubMed 35915452Serigstad S, Ritz C, Faurholt-Jepsen D, Markussen D, Ebbesen MH, Kommedal O, Bjorneklett RO, Heggelund L, Clark TW, van Werkhoven CH, Knoop ST, Ulvestad E, Grewal HMS; CAPNOR study group. Impact of rapid molecular testing on diagnosis, treatment and management of community-acquired pneumonia in Norway: a pragmatic randomised controlled trial (CAPNOR). Trials. 2022 Aug 1;23(1):622. doi: 10.1186/s13063-022-06467-7.
- 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.
Harleen Grewal, MD PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-rapid molecular point-of-care testing in people with Pneumonia, run by Haukeland University Hospital at 1 site in Norway.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 Oct 2023. 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 Norway. 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 was stopped early (reason given: The trial was stopped earlier than planned after an ad hoc interim analysis). Results are not available in the source record.
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?
The provision of pathogen-directed treatment based on a microbiological test result deemed as clinically relevant within 48 hours of receipt of respiratory samples. (time frame: "Up to 72 hours"). 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?
On the ClinicalTrials.gov record for NCT04660084, which also lists 5 linked publications.
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 26 Oct 2023.