Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04660084
Status:
TERMINATED
Last Update Posted:
2023-10-26
First Post:
2020-11-12
Brief Title:
Impact of Molecular Testing on Improved Diagnosis Treatment and Management of CAP
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
Impact of Molecular Testing on Improved Diagnosis Treatment and Management of CAP in Norway a Pragmatic Randomised Controlled Trial
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial was stopped earlier than planned after an ad hoc interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPNOR
Brief 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 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 patients 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 900year 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 newworsening cough newworsening expectoration of sputum haemoptysis newworsening 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 patients 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 11 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 antimicrobials 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
Investigators will over a 3-year period 2020-2022 consecutively enroll cases of CAP admitted 900year 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 newworsening cough newworsening expectoration of sputum haemoptysis newworsening 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 patients 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 11 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 antimicrobials 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None