About The Clinical Trial
Trial Name: Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP (CAPNOR)
ClinicalTrials.gov ID: NCT04660084
Sponsor: Haukeland University Hospital
Completion Date (Actual): June 2022
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Study: PCR-Based Testing Results in Faster, Targeted Treatment for Community-Acquired Pneumonia
When considering community-acquired pneumonia alone, the PCR test identified 113 bacterial detections compared with 57 for the standard of care test.
The usage of polymerase chain reaction (PCR)-based testing for lower respiratory tract pathogens resulted in faster and more targeted treatment for individuals with suspected community-acquired pneumonia (CAP), according to results of a study published in JAMA Network Open. In the clinical trial (NCT04660084), the investigators aimed to determine whether the use of PCR tests led to faster and more accurate test result-based treatment for patients with CAP in the emergency department (ED).
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In the trial, patients were recruited from September 25, 2020, to June 1, 2021, then from August 15, 2021, to June 21, 2022, according to the study authors. Individuals were included if they were aged 18 years or older and presented to the ED with suspected CAP and 2 symptoms, including “new or worsening cough, new or worsening expectoration, new or worsening dyspnea, hemoptysis, pleuritic chest pain, radiological evidence of pneumonia, abnormalities on chest auscultation and/or percussion, or fever,” according to the study criteria. Patients were excluded if they had cystic fibrosis, severe bronchiectasis, were hospitalized within the past 14 days prior to admission, under palliative care, or were unwilling to give a sample, according to the study authors.
Tests were randomized to patients 1:1 with the intervention arm receiving rapid syndromic PCR testing in addition to the standard-of-care diagnostics, or the standard-of-care arm which did not receive the PCR test. There were 2 primary outcomes in the study: provision of treatment based on test result and time to provision of treatment within 48 hours after randomization.
Investigators included 374 patients, with 187 patients assigned to each arm. There were similar patient characteristics in each arm, according to the study authors. The total population was 40.9% female with a median age of 72 years and 208 had CAP. Only 200 provided a lower respiratory tract sample, according to the study authors. Of those 200, 97 were in the intervention arm and 103 were in the standard-of-care arm.
According to the study authors, the trial was ended early following an interim analysis carried out on June 16, 2022, due to slow recruitment. The interim analysis showed differences between both treatment arms for both primary endpoints, according to the results.
Investigators found that 47.4% of those in the intervention arm and 15.5% of those in the standard-of-care arm received pathogen-directed treatment within 48 hours, with a median time to provision of 29.9 hours and 42.3 hours, respectively. The secondary endpoint of turnaround time was significantly slower for the intervention group compared with the standard of care.
Additionally, the median lengths of stay were similar, at 3.3 days and 3.2 days for the intervention and standard-of-care arms, respectively. In the intervention arm, 15.5% were readmitted compared to 18.7% in the standard-of-care arm. Nine patients died in the intervention arm within 30 days and 16 patients died within 90 days compared with 7 and 11 patients, respectively, in the standard-of care arm.
Furthermore, investigators found that the intervention arm had a higher rate of bacterial detections (175) and viral detections (74) compared to the standard-of-care arm at 72 and 34, respectively. When considering CAP alone, the numbers remained high with the intervention arm at 113 compared to 57 and 39 compared to 34, respectively.
There were no serious adverse events (AEs) observed and AEs were similar in both arms for saline-induced sputum, according to the study authors. Investigators of the clinical trial determined that these tests might be used as complementary or could even replace selected standard laboratory-based diagnostics.
Reference
Markussen DL, Serigstad S, Ritz C, et al. Diagnostic Stewardship in Community-Acquired Pneumonia With Syndromic Molecular Testing: A Randomized Clinical Trial. JAMA Netw Open. 2024;7(3):e240830. 2024. doi:10.1001/jamanetworkopen.2024.0830
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