The Place of Imaging and Microbiology in the Diagnosis of Pneumonia in the Elderly: PneumOldCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Number of Patients With Modified Diagnosis Probability After Low Dose CT (LDCT)
研究概览
简要总结
Diagnosis of pneumonia in the elderly is difficult because of the poor sensitivity and specificity of clinical signs as well as images from chest radiography (RT). New diagnostic tools such as thoracic low-dose computed tomography (CT), which exposes the patient to a weak dose of irradiation, could improve diagnosis. Moreover, low-dose CT could provide additional accuracy in the etiological clarification of pneumonia in elderly people.
As a first step, the investigators aim to perform a 1 year (12 months of inclusion + 3 months of follow-up) prospective study including the Divisions of Internal Medicine, Rehabilitation, Geriatrics and Radiology of the University Hospitals of Geneva. In this study, patients >65 years old with a clinical suspicion of low respiratory tract infection (LRTI) will be included. They will be prescribed antimicrobial therapy. Both chest radiography and low-dose thoracic CT will be performed within the first 72 hours after admission, as will blood tests and a nasopharyngeal swab.
The clinician's diagnosis, both before and after the results of the CT, will be compared at the end of the study to the adjudication committee's diagnostic opinion which will have access to all available clinical, laboratory and chest X-ray data and which will be considered the gold standard. At the end of the study, all the CT images will be blind-reviewed by two experts in radiology. The impact of CT scanning in the diagnosis of pneumonia will be assessed, both for its sensitivity and specificity in this population.
During the first 12 months of the study, all patients will undergo a systematic nasopharyngeal swab at admission and at discharge, from which eluates will be conserved. During the next 12 months, virological and bacteriological polymerase chain reactions (PCR) will be performed, using new diagnostic tools, in order to determine the etiological diagnosis in this population and to evaluate the impact of the new tools in the management of pneumonia for this population.
Analysis of these data will allow clinical, radiological and microbiological correlation.
详细描述
The project's principal aim is to assess the impact of low-dose CT scanning versus chest radiography in the diagnosis of pneumonia in elderly patients.
One of the secondary objectives is to estimate sensitivity and specificity of CT scanning in pneumonia diagnosis in the elderly (gold standard: adjudication committee advice).
This prospective study should be considered a preliminary feasibility study in preparation for a future randomized clinical trial comparing patient management, antibiotic prescription and clinical outcomes between one group of patients with LRTI randomized to routine thoracic CT scan and one group randomized to usual care.
The second phase of this study will explore the etiologies of pneumonia in the elderly using new diagnostic tools. This will lead to identify radiological patterns associated with clinical presentation and microbiological results.
Primary objective: to estimate the impact of CT scanning in the diagnosis of pneumonia in elderly patients, in a monocentric study (but within two sites, Service de Médecine Interne Générale and Hôpital des Trois-Chêne).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients above 65 years old
- •AND at least one infectious sign: T° >38°C or <35°C; C-reactive protein (CRP) >10 mg/L; leucocytes >10,000/mL with >85% polynuclear neutrophils or left deviation,
- •AND at least one respiratory sign: cough; purulent sputum; chest pain; localized crackles; recently appeared dyspnea; oxygen saturation (SpO2) <90%; respiratory frequency >20/min,
- •AND who will be prescribed antimicrobial therapy for suspicion of low respiratory tract infection,
- •AND who will give consent himself or through his support person.
排除标准
- •Diagnosis of pneumonia in the previous six months,
- •AND/OR more than 48h of antimicrobial treatment given before hospitalization,
- •AND/OR thoracic CT scan performed before hospitalization or inclusion of the patient.
- •Each patient will be included only once.
结局指标
主要结局
Number of Patients With Modified Diagnosis Probability After Low Dose CT (LDCT)
时间窗: During the 24 hours after CT
Number and proportion of patients whose probability of pneumonia changed before and after LDCT : upgraded (increase of probability of pneumonia) or downgraded (decrease of probability of pneumonia)
次要结局
- Number of Bacterial and Viral Pulmonary Infections(At inclusion (during the first 72 hours after CT))
研究者
Virginie Prendki
Attending Staff Member
University Hospital, Geneva