CompletedNot Applicable

CT Scan Compared to CXR and LUS in Pneumonia in the Elderly

Switzerland473 participantsStarted 2021-06-17

Plain-language summary

Introduction: Pneumonia is a leading cause of mortality and a common indication for antibiotic in elderly patients. However, its diagnosis is often inaccurate. The investigators 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 US (LUS). Methods and analysis: This is a multicenter randomized 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 vs 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, the investigatory 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). Impact of the study: Superiority of the LDCT or LUS strategy over CXR would affect recommendations for the diagnosis of pneumonia in elderly patients. A higher accuracy of one of the strategies may decrease antibiotics overuse and lead to better outcomes and reduced costs.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Aged \>65 years * Suspected community-acquired or nursing-home acquired pneumonia consulting to the emergency room with at least one respiratory symptom (new or increasing among: cough, purulent sputum, pleuritic chest pain, dyspnea, respiratory rate \>20/min, focal auscultatory findings or oxygen saturation \<90% on room air) AND at least one symptom or laboratory finding compatible with an infection (temperature \>37.8°C or \<36.0°C, C reactive protein (CRP) \>10 mg/L, PCT \>0.25 µg/L, leukocyte count \>10 G/L with \>85% neutrophils or band forms) * Signed informed consent * In the oldest old (patients aged \>80 years), the presence of acute delirium or unexplained acute fall can substitute for the presence of either the respiratory or the infectious symptom Exclusion Criteria: * Immediate admission to the intensive care unit (ICU) * Pneumonia in the past 3 months * PCR or antigenic test positive for SARS-CoV-2 in the 3 past weeks * Transfer from another hospital with a diagnosis of pneumonia * CXR or thoracic CT scan or US already done during the present episode * Immediate contrast-enhanced CT scan needed * Advanced care planning limiting therapy to comfort care only * Prisoners * Known uncontrolled psychiatric disorders * Previous enrollment into the current study.

What they're measuring

Accuracy of the clinician's diagnosis of pneumonia

Timeframe: Before the patient is discharged from the Emergency Room (Day 0 -an average of 10 hours)

Trial details

NCT IDNCT04978116

SponsorUniversity Hospital, Geneva

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-03