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Scientific article
Open access
English

LOw-dose CT Or Lung UltraSonography versus standard of care based-strategies for the diagnosis of pneumonia in the elderly: protocol for a multicentre randomised controlled trial (OCTOPLUS)

Published inBMJ open, vol. 12, no. 5, e055869
Publication date2022-05-06
First online date2022-05-06
Abstract

Introduction: Pneumonia is a leading cause of mortality and a common indication for antibiotic in elderly patients. However, its diagnosis is often inaccurate. We aim to compare the diagnostic accuracy, the clinical and cost outcomes and the use of antibiotics associated with three imaging strategies in patients >65 years old with suspected pneumonia in the emergency room (ER): chest X-ray (CXR, standard of care), low-dose CT scan (LDCT) or lung ultrasonography (LUS).

Methods and analysis: This is a multicentre randomised superiority clinical trial with three parallel arms. Patients will be allocated in the ER to a diagnostic strategy based on either CXR, LDCT or LUS. All three imaging modalities will be performed but the results of two of them will be masked during 5 days to the patients, the physicians in charge of the patients and the investigators according to random allocation. The primary objective is to compare the accuracy of LDCT versus CXR-based strategies. As secondary objectives, antibiotics prescription, clinical and cost outcomes will be compared, and the same analyses repeated to compare the LUS and CXR strategies. The reference diagnosis will be established a posteriori by a panel of experts. Based on a previous study, we expect an improvement of 16% of the accuracy of pneumonia diagnosis using LDCT instead of CXR. Under this assumption, and accounting for 10% of drop-out, the enrolment of 495 patients is needed to prove the superiority of LDCT over CRX (alpha error=0.05, beta error=0.10).

Ethics and dissemination: Ethical approval: CER Geneva 2019-01288.

Trial registration number: NCT04978116.

eng
Keywords
  • Respiratory infections
  • Thoracic medicine
  • Aged
  • Anti-Bacterial Agents / therapeutic use
  • Humans
  • Lung / diagnostic imaging
  • Multicenter Studies as Topic
  • Pneumonia / diagnostic imaging
  • Pneumonia / drug therapy
  • Randomized Controlled Trials as Topic
  • Standard of Care
  • Tomography, X-Ray Computed
  • Ultrasonography / methods
  • Geriatric medicine
Citation (ISO format)
PRENDKI, Virginie et al. LOw-dose CT Or Lung UltraSonography versus standard of care based-strategies for the diagnosis of pneumonia in the elderly: protocol for a multicentre randomised controlled trial (OCTOPLUS). In: BMJ open, 2022, vol. 12, n° 5, p. e055869. doi: 10.1136/bmjopen-2021-055869
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ISSN of the journal2044-6055
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Technical informations

Creation10/06/2022 12:53:00 PM
First validation10/06/2022 12:53:00 PM
Update time03/16/2023 10:51:37 AM
Status update03/16/2023 10:51:34 AM
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