Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04660084 |
| Other study ID # |
HaukelandUH_31935 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 25, 2020 |
| Est. completion date |
June 21, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Haukeland University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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
