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

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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Pneumonia
Intervention Device: Low dose CT
Enrollment 203
Recruitment Details Between 1 May 2015 and 30 April 2016, we enrolled consecutive hospitalised patients aged 65 years old or more, with a suspicion of CAP or hospital-acquired pneumonia, and being treated with antimicrobial therapy (AT) for that indication.
Pre-assignment Details  
Arm/Group Title Thoracic Low Dose CT
Hide Arm/Group Description A LDCT scan, without administration of intra-venous contrast, was performed as soon as possible after the first Likert scale estimate, ideally within 24h of inclusion in the study, but no later than 72h.
Period Title: Overall Study
Started 203
Completed 200
Not Completed 3
Reason Not Completed
Death             1
revealed to have pneumonia before             2
Arm/Group Title Thoracic Low Dose CT
Hide Arm/Group Description A LDCT scan, without administration of intra-venous contrast, was performed as soon as possible after the first Likert scale estimate, ideally within 24h of inclusion in the study, but no later than 72h.
Overall Number of Baseline Participants 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 200 participants
84.0
(78.6 to 90.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Female
100
  50.0%
Male
100
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 200 participants
200
1.Primary Outcome
Title Number of Patients With Modified Diagnosis Probability After Low Dose CT (LDCT)
Hide Description 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)
Time Frame During the 24 hours after CT
Hide Outcome Measure Data
Hide Analysis Population Description
The probability was upgraded in 15% (n=30) of patients and downgraded in 30% (n=60). 60 patients have downgraded probability after LDCT (34+13+13) and 30 patients have upgraded probability after LDCT (3+4+23) ie 90 (45 %) patients have modified diagnosis probability with Low dose CT.
Arm/Group Title Low Probability of Pneumonia After LDCT Intermediate Probability of Pneumonia After LDCT High Probability of Pneumonia After LDCT
Hide Arm/Group Description:
Clinician's estimates of low probability of pneumonia after LDCT chest scan
Clinician's estimates of Intermediate probability of pneumonia after LDCT chest scans
Clinician's estimates of high probability of pneumonia after LDCT chest scan
Overall Number of Participants Analyzed 57 29 114
Measure Type: Count of Participants
Unit of Measure: Participants
Low probability of pneumonia before LDCT 10 3 4
Intermediate probability of pneumonia before LDCT 34 13 23
High probability of pneumonia before LDCT 13 13 87
2.Secondary Outcome
Title Number of Bacterial and Viral Pulmonary Infections
Hide Description

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).

Time Frame At inclusion (during the first 72 hours after CT)
Hide Outcome Measure Data
Hide Analysis Population Description

62 patients (31%) had positive Polymerase Chain Reaction (PCR) for at least one virus in the naso- and oropharyngeal swab (NPS) performed at inclusion.

73 (37%) patients had a positive PCR for a bacteria at inclusion. Routine methods allowed to diagnose the presumptive etiology of pneumonia in 22 patients.

Arm/Group Title With Pneumonia on LDCT No Pneumonia on LDCT
Hide Arm/Group Description:
presence of pneumonia on a low-dose CT-scan as assessed by two independent expert radiologists
Absence of pneumonia on a low-dose CT-scan as assessed by two independent expert radiologists
Overall Number of Participants Analyzed 127 72
Measure Type: Count of Participants
Unit of Measure: Participants
Positive PCR for virus
45
  35.4%
17
  23.6%
Positive PCR for bacterial
50
  39.4%
23
  31.9%
microbiologic routine methods
18
  14.2%
4
   5.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Thoracic Low Dose CT
Hide Arm/Group Description A LDCT scan, without administration of intra-venous contrast, was performed as soon as possible after the first Likert scale estimate, ideally within 24h of inclusion in the study, but no later than 72h.
All-Cause Mortality
Thoracic Low Dose CT
Affected / at Risk (%)
Total   0/203 (0.00%) 
Hide Serious Adverse Events
Thoracic Low Dose CT
Affected / at Risk (%)
Total   0/203 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Thoracic Low Dose CT
Affected / at Risk (%)
Total   0/203 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Jerome Stirnemann
Organization: Hopitaux Universitaires de Geneve
Phone: +41223729101
EMail: jerome.stirnemann@hcuge.ch
Layout table for additonal information
Responsible Party: Virginie Prendki, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02467192    
Other Study ID Numbers: 14-250
First Submitted: May 27, 2015
First Posted: June 9, 2015
Results First Submitted: November 20, 2020
Results First Posted: November 2, 2021
Last Update Posted: November 2, 2021