Low-dose CT Compared to Lung Ultrasonography vs Standard of Care for the Diagnosis of Pneumonia in the Elderly: a Multicentre Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 473
- 试验地点
- 3
- 主要终点
- Accuracy of the clinician's diagnosis of pneumonia
研究概览
简要总结
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.
详细描述
This study will be conducted in three academic hospitals and one tertiary care hospital in Switzerland: Geneva University Hospitals, Geneva; Inselspital, Bern; Regional Hospital Lugano, Lugano; and Riviera Chablais Hospital, Rennaz.
Study design This is a multicenter randomized superiority clinical trial with three parallel arms aiming to compare the accuracy of imaging-based strategies for diagnosis of pneumonia in elderly patients admitted to the ER.
Each patient will be randomly allocated in the ER to one of the three imaging examination (CXR, LDCT or LUS), which will be immediately performed, interpreted by one of two independent radiologists (one for CXR and one for LDCT) or by an independent emergency physician trained in ultrasonography (LUS) and reported in a standardized form. The physician in charge of the patient will have access to the imaging examination and the corresponding report, in addition to usual clinical and biological data obtained in the diagnostic work-up of suspected pneumonia; he/she will be asked to assess the probability of pneumonia before the patient is discharged from the ER.
For each patient, the two other imaging examinations will also be performed and interpreted as described above, but the physician in charge of the patient will be blinded to these results. The results of all three imaging examinations and the interpretation will however be available to the panel of experts, whose final diagnosis of pneumonia will be the reference diagnosis for the study.
All enrolled patients will be followed up by study staff during hospitalization and by phone at month 1 and 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
The care provider (clinician in charge) will be also be the outcome assessor and will know the allocation arm.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Chest X-Ray (CXR)
Only CXR (image and standardized report) will be available to the clinician in charge of the patient (standard of care). LDCT and LUS will be performed but not available (clinician will be blinded to LDCT and LUS).
干预措施: Chest X-Ray (CXR) (Diagnostic Test)
Chest X-Ray (CXR)
Only CXR (image and standardized report) will be available to the clinician in charge of the patient (standard of care). LDCT and LUS will be performed but not available (clinician will be blinded to LDCT and LUS).
干预措施: Low-dose CT scan (LDCT) (Diagnostic Test)
Chest X-Ray (CXR)
Only CXR (image and standardized report) will be available to the clinician in charge of the patient (standard of care). LDCT and LUS will be performed but not available (clinician will be blinded to LDCT and LUS).
干预措施: Lung ultrasonography (LUS) (Diagnostic Test)
Low-dose CT scan (LDCT)
Only LDCT (image and standardized report) will be available to the clinician (first intervention arm). CXR and LUS will be performed but not available (clinician will be blinded to CXR and LUS).
干预措施: Chest X-Ray (CXR) (Diagnostic Test)
Low-dose CT scan (LDCT)
Only LDCT (image and standardized report) will be available to the clinician (first intervention arm). CXR and LUS will be performed but not available (clinician will be blinded to CXR and LUS).
干预措施: Low-dose CT scan (LDCT) (Diagnostic Test)
Low-dose CT scan (LDCT)
Only LDCT (image and standardized report) will be available to the clinician (first intervention arm). CXR and LUS will be performed but not available (clinician will be blinded to CXR and LUS).
干预措施: Lung ultrasonography (LUS) (Diagnostic Test)
Lung ultrasonography (LUS)
Only LUS (image and standardized report) will be available to the clinician (second intervention arm). CXR and LDCT will be performed but not available (clinician will be blinded to CXR and LDCT).
干预措施: Chest X-Ray (CXR) (Diagnostic Test)
Lung ultrasonography (LUS)
Only LUS (image and standardized report) will be available to the clinician (second intervention arm). CXR and LDCT will be performed but not available (clinician will be blinded to CXR and LDCT).
干预措施: Low-dose CT scan (LDCT) (Diagnostic Test)
Lung ultrasonography (LUS)
Only LUS (image and standardized report) will be available to the clinician (second intervention arm). CXR and LDCT will be performed but not available (clinician will be blinded to CXR and LDCT).
干预措施: Lung ultrasonography (LUS) (Diagnostic Test)
结局指标
主要结局
Accuracy of the clinician's diagnosis of pneumonia
时间窗: Before the patient is discharged from the Emergency Room (Day 0 -an average of 10 hours)
The probability of pneumonia will be rated by the clinician in charge, before the patient is discharged from the Emergency Room, on a 3-level Likert scale ("low", "intermediate" or "high").The probability of pneumonia will be rated by the panel of experts a posteriori on the same scale. For the primary outcome, a diagnosis of pneumonia will be positive if the probability is rated "intermediate" or "high" and negative if the probability is rated "low". The accuracy will be the proportion of patients with a clinician's diagnosis (either negative or positive) matching with the panel of experts' diagnosis which is considered as the reference. Grouping the levels "intermediate" or "high" makes sense from a medical decision making perspective since a patient rated "intermediate" will be treated with antibiotics in the same way as a patient rated "high". In a secondary analysis, the diagnosis of pneumonia will be considered positive only if the probability is rated "high".
次要结局
- Proportion of patients with unmasked imaging modalities in the emergency room(Before the patient is discharged from the Emergency Room (Day 0 -an average of 10 hours))
- Antibiotic free days at day 30 (for any indication)(30 days)
- Proportion of patients with an additional imaging ordered(Before the patient is discharged from the hospital (an average of 3-4 weeks))
- Length of hospital stay(3 months)
- Sensitivity and specificity of imaging-based strategies (CXR, LDCT and LUS)(Before the patient is discharged from the Emergency Room (Day 0 -an average of 10 hours))
- Proportion of patients transfered to the intensive care unit(3 months)
- All cause readmission rate(3 months)
- Cost-outcomes(3 months)
- All cause mortality rate(3 months)
研究者
Virginie Prendki
Sponsor, Principal investigator
University Hospital, Geneva