The Place of Imaging and Microbiology in the Diagnosis of Pneumonia in the Elderly

NCT02467192 | Completed Results

• 1 other identifier: 14-250
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Modified Diagnosis Probability After Low Dose CT (LDCT)

  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)

  During the 24 hours after CT

Secondary Outcomes (1)

• Number of Bacterial and Viral Pulmonary Infections

  At inclusion (during the first 72 hours after CT)

Study Arms (1)

Low dose CT

EXPERIMENTAL

All patients will have Thoracic CT scan

Device: Low dose CT

Interventions

Low dose CT DEVICE

Thoracic CT scan will be performed within the first 48-72 hours of admission, with an analysis and conclusion by a radiologist

Low dose CT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of pneumonia in the previous six months,
• AND/OR more than 48h of antimicrobial treatment given before hospitalization,
• Each patient will be included only once.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

HUG

Geneva, 1211, Switzerland

Location

Related Publications (4)

• Ulaj A, Ibsen A, Azurmendi L, Sanchez JC, Prendki V, Roux X. Improving prognostication of pneumonia among elderly patients: usefulness of suPAR. BMC Geriatr. 2024 Aug 24;24(1):709. doi: 10.1186/s12877-024-05270-0.

  PMID: 39182045 DERIVED

• Hofmeister J, Garin N, Montet X, Scheffler M, Platon A, Poletti PA, Stirnemann J, Debray MP, Claessens YE, Duval X, Prendki V. Validating the accuracy of deep learning for the diagnosis of pneumonia on chest x-ray against a robust multimodal reference diagnosis: a post hoc analysis of two prospective studies. Eur Radiol Exp. 2024 Feb 2;8(1):20. doi: 10.1186/s41747-023-00416-y.

  PMID: 38302850 DERIVED

• Prendki V, Huttner B, Marti C, Mamin A, Fubini PE, Meynet MP, Scheffler M, Montet X, Janssens JP, Reny JL, Kaiser L, Garin N, Stirnemann J. Accuracy of comprehensive PCR analysis of nasopharyngeal and oropharyngeal swabs for CT-scan-confirmed pneumonia in elderly patients: a prospective cohort study. Clin Microbiol Infect. 2019 Sep;25(9):1114-1119. doi: 10.1016/j.cmi.2018.12.037. Epub 2019 Jan 12.

  PMID: 30641227 DERIVED

• Prendki V, Scheffler M, Huttner B, Garin N, Herrmann F, Janssens JP, Marti C, Carballo S, Roux X, Serratrice C, Serratrice J, Agoritsas T, Becker CD, Kaiser L, Rosset-Zufferey S, Soulier V, Perrier A, Reny JL, Montet X, Stirnemann J. Low-dose computed tomography for the diagnosis of pneumonia in elderly patients: a prospective, interventional cohort study. Eur Respir J. 2018 May 30;51(5):1702375. doi: 10.1183/13993003.02375-2017. Print 2018 May.

  PMID: 29650558 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Jerome Stirnemann
• Organization: Hopitaux Universitaires de Geneve

jerome.stirnemann@hcuge.ch

+41223729101

Study Officials

• Virginie Prendki, MD

  HUG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Staff Member

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 9, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Locations

CH (1)