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)

IntroductionPneumonia 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...

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Published in:	BMJ open Vol. 12; no. 5; p. e055869
Main Authors:	Prendki, Virginie, Garin, Nicolas, Stirnemann, Jerome, Combescure, Christophe, Platon, Alexandra, Bernasconi, Enos, Sauter, Thomas, Hautz, Wolf, Argentieri, Gianluca, Baumgartner, Christine, Boehm-Bosmani, Cristina, Birrenbach, Tanja, Cuvelier, Clémence, Fehlmann, Christophe, Gosselin, Pauline, Grosgurin, Olivier, Herrmann, François, Jessula, Alessandro, Kaiser, Laurent, Kharat, Aileen, Lachat, Véronique, Lambrigger, Cornelia, Lehmann, Beat, Leidi, Antonio, Marchi, Elisa, Marti, Christophe, Martinvalet, Mihaela, Morosoli, Lara, Ott, Daniel, Parent, Thibault, Poletti, Pierre-Alexandre, Reny, Jean-Luc, Roux, Xavier, Rouyer, Frédéric, Ruder, Thomas, Scheffler, Max, Soret, Guillaume, Tessieras, Jérôme, Vindret, Catherine, Zekry, Dina, Zucconi, Enrico
Format:	Journal Article
Language:	English
Published:	England British Medical Journal Publishing Group 06-05-2022 BMJ Publishing Group LTD BMJ Publishing Group
Series:	Protocol
Subjects:	Accuracy Aged Anti-Bacterial Agents - therapeutic use Antibiotics Emergency medical care Emergency Medicine GERIATRIC MEDICINE Humans Lung - diagnostic imaging Medical diagnosis Medical imaging Multicenter Studies as Topic Older people Patients Pneumonia Pneumonia - diagnostic imaging Pneumonia - drug therapy Randomized Controlled Trials as Topic Respiratory infections Standard of Care Thoracic medicine Tomography, X-Ray Computed Ultrasonic imaging Ultrasonography - methods GERIATRIC MEDICINE Respiratory infections Thoracic medicine
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Summary:	IntroductionPneumonia 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 analysisThis 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 disseminationEthical approval: CER Geneva 2019-01288.Trial registration number NCT04978116.
Bibliography:	Protocol ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2021-055869