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)

Virginie Prendki, Nicolas Garin, Jerome Stirnemann, Christophe Combescure, Alexandra Platon, Enos Bernasconi, Thomas Sauter, Wolf Hautz, OCTOPLUS study group, Nicolas Garin, Christophe Combescure, Gianluca Argentieri, Christine Baumgartner, Cristina Boehm-Bosmani, Tanja Birrenbach, Clémence Cuvelier, Christophe Fehlmann, Pauline Gosselin, Olivier Grosgurin, François Herrmann, Alessandro Jessula, Laurent Kaiser, Aileen Kharat, Véronique Lachat, Cornelia Lambrigger, Beat Lehmann, Antonio Leidi, Elisa Marchi, Christophe Marti, Mihaela Martinvalet, Lara Morosoli, Daniel Ott, Thibault Parent, Pierre-Alexandre Poletti, Jean-Luc Reny, Xavier Roux, Frédéric Rouyer, Thomas Ruder, Max Scheffler, Guillaume Soret, Jérôme Tessieras, Catherine Vindret, Dina Zekry, Enrico Zucconi, Virginie Prendki, Nicolas Garin, Jerome Stirnemann, Christophe Combescure, Alexandra Platon, Enos Bernasconi, Thomas Sauter, Wolf Hautz, OCTOPLUS study group, Nicolas Garin, Christophe Combescure, Gianluca Argentieri, Christine Baumgartner, Cristina Boehm-Bosmani, Tanja Birrenbach, Clémence Cuvelier, Christophe Fehlmann, Pauline Gosselin, Olivier Grosgurin, François Herrmann, Alessandro Jessula, Laurent Kaiser, Aileen Kharat, Véronique Lachat, Cornelia Lambrigger, Beat Lehmann, Antonio Leidi, Elisa Marchi, Christophe Marti, Mihaela Martinvalet, Lara Morosoli, Daniel Ott, Thibault Parent, Pierre-Alexandre Poletti, Jean-Luc Reny, Xavier Roux, Frédéric Rouyer, Thomas Ruder, Max Scheffler, Guillaume Soret, Jérôme Tessieras, Catherine Vindret, Dina Zekry, Enrico Zucconi

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.

Keywords: GERIATRIC MEDICINE; Respiratory infections; Thoracic medicine.

Conflict of interest statement

Competing interests: WH has received research funding from the European Union, the Swiss National Science foundation, Zoll foundation, Dräger Medical Germany, Mundipharma Research UK, MDI International Australia, Roche Diagnostics Germany, all outside the submitted work. WH has provided paid consultancies to AO foundation Switzerland and MDI International Australia, all outside the submitted work. WH has received financial support for a congress he chaired from EBSCO Germany, Isabel Healthcare UK, Mundipharma Medical Switzerland, VisualDx USA, all outside the submitted work.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study design. CXR, chest X-ray; ER, emergency room; LDCT, low-dose CT scan; LUS, lung ultrasonography.

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