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The Place of Imaging and Microbiology in the Diagnosis of Pneumonia in the Elderly (PneumOldCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02467192
Recruitment Status : Completed
First Posted : June 9, 2015
Results First Posted : November 2, 2021
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Virginie Prendki, University Hospital, Geneva

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.


Condition or disease Intervention/treatment Phase
Pneumonia Device: Low dose CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Place of Imaging and Microbiology in the Diagnosis of Pneumonia in the Elderly: PneumOldCT
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Low dose CT
All patients will have Thoracic CT scan
Device: Low dose CT
Thoracic CT scan will be performed within the first 48-72 hours of admission, with an analysis and conclusion by a radiologist




Primary Outcome Measures :
  1. Number of Patients With Modified Diagnosis Probability After Low Dose CT (LDCT) [ Time Frame: 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)


Secondary Outcome Measures :
  1. Number of Bacterial and Viral Pulmonary Infections [ Time Frame: At inclusion (during the first 72 hours after CT) ]

    Number of patients with viral pulmonary infection: patients with positive PCR for at least one virus in the naso- and oropharyngeal swab (NPS) performed at inclusion,

    Number of patients with bacterial infection: patients with positive PCR for a bacteria in the NPS at inclusion and/or with routine microbiologic methods (blood and sputum culture, urine antigen detection).




Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467192


Locations
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Switzerland
HUG
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Virginie Prendki, MD HUG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Virginie Prendki, Attending Staff Member, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02467192    
Other Study ID Numbers: 14-250
First Posted: June 9, 2015    Key Record Dates
Results First Posted: November 2, 2021
Last Update Posted: November 2, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases