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

NCT04978116 | Completed DMC

• 1 other identifier: 2019-01288
• Study Type: interventional
• Target: 473
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pneumonia; Elderly Infection

Keywords

Chest X-ray; Low-dose CT scan; Lung ultrasonography

Outcome Measures

Primary Outcomes (1)

• Accuracy of the clinician's diagnosis of pneumonia

  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".

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

Secondary Outcomes (9)

• 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 with unmasked imaging modalities in the emergency room

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

• Proportion of patients with an additional imaging ordered

  Before the patient is discharged from the hospital (an average of 3-4 weeks)

• Antibiotic free days at day 30 (for any indication)

  30 days

• Length of hospital stay

  3 months

Study Arms (3)

Chest X-Ray (CXR)

EXPERIMENTAL

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).

Diagnostic Test: Chest X-Ray (CXR); Diagnostic Test: Low-dose CT scan (LDCT); Diagnostic Test: Lung ultrasonography (LUS)

Low-dose CT scan (LDCT)

EXPERIMENTAL

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).

Diagnostic Test: Chest X-Ray (CXR); Diagnostic Test: Low-dose CT scan (LDCT); Diagnostic Test: Lung ultrasonography (LUS)

Lung ultrasonography (LUS)

EXPERIMENTAL

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).

Diagnostic Test: Chest X-Ray (CXR); Diagnostic Test: Low-dose CT scan (LDCT); Diagnostic Test: Lung ultrasonography (LUS)

Interventions

Chest X-Ray (CXR) DIAGNOSTIC_TEST

The 3 following imagings will be performed in the emergency room: chest X-Ray (CXR), low-dose CT scan (LDCT) and lung ultrasonography (LUS) will be performed for all included patients, but only one will be available to the clinician in charge of the patient according to the allocation arm. The blinding will be maintained during the first 5 days, and hence will not influence the diagnosis and the treatment of the patient. The clinician in charge will be asked to assess on a 3-level Likert scale the probability of pneumonia (high, intermediate, low level) while considering all available clinical and biological data, plus the imaging modality according to the randomization arm.

Chest X-Ray (CXR); Low-dose CT scan (LDCT); Lung ultrasonography (LUS)

Low-dose CT scan (LDCT) DIAGNOSTIC_TEST

See above in CXR paragraph

Chest X-Ray (CXR); Low-dose CT scan (LDCT); Lung ultrasonography (LUS)

Lung ultrasonography (LUS) DIAGNOSTIC_TEST

See above in CXR paragraph. LUS will be performed by another clinician than the one in charge of the patient

Chest X-Ray (CXR); Low-dose CT scan (LDCT); Lung ultrasonography (LUS)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• Ospedale Regionale di Lugano: collaborator

Study Sites (3)

Inselspital

Bern, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Ospedale regionale di Lugano

Lugano, Switzerland

Location

Related Publications (2)

• Prendki V, Garin N, Stirnemann J, Combescure C, Platon A, Bernasconi E, Sauter T, Hautz W; OCTOPLUS study group. 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). BMJ Open. 2022 May 6;12(5):e055869. doi: 10.1136/bmjopen-2021-055869.

  PMID: 35523502 RESULT

• Stirnemann J, Serratrice J, Mann T, Louge P, Christophe C, Samii K, Pignel R, Agoritsas T, Ansari M, Cannas G, Chalandon Y, Cimasoni L, Cougoul P, Desgraz B, Gervaix A, Grosgurin O, Joffre T, Lae C, Magnan MA, Menager E, Momo Bona A, Panchard MA, Pellegrini M, Reny JL, Riu B, Sahyoun C, Boet S. Protocol for a multicentric, double-blind, randomised controlled trial of hyperbaric oxygen therapy (HBOT) versus sham for treating vaso-occlusive crisis (VOC) in sickle cell disease (SCD) in patients aged 8 years or older (HBOT-SCD study). BMJ Open. 2024 Nov 28;14(11):e084825. doi: 10.1136/bmjopen-2024-084825.

  PMID: 39613437 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Diagnostic Imaging; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Virginie Prendki, Dr

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The care provider (clinician in charge) will be also be the outcome assessor and will know the allocation arm.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor, Principal investigator

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 27, 2021
• Study Start: June 17, 2021
• Primary Completion: May 3, 2025
• Study Completion: July 1, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the end of the protocol
• Access Criteria: As described in the data management plan, data will be shared according to FAIR data principles and thus in a FAIR-compliant data repository

Locations

CH (3)