Trial Outcomes & Findings for The Place of Imaging and Microbiology in the Diagnosis of Pneumonia in the Elderly (NCT NCT02467192)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

203 participants

Primary outcome timeframe

During the 24 hours after CT

Results posted on

2021-11-02

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Thoracic Low Dose CT 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 Study STARTED	203
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Thoracic Low Dose CT 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 Study Death	1
Overall Study revealed to have pneumonia before	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thoracic Low Dose CT n=200 Participants 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.
Age, Continuous	84.0 years n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants
Region of Enrollment Switzerland	200 participants n=5 Participants

PRIMARY outcome

Timeframe: During the 24 hours after CT

Population: 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.

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)

Outcome measures

Outcome measures
Measure	Low Probability of Pneumonia After LDCT n=57 Participants Clinician's estimates of low probability of pneumonia after LDCT chest scan	Intermediate Probability of Pneumonia After LDCT n=29 Participants Clinician's estimates of Intermediate probability of pneumonia after LDCT chest scans	High Probability of Pneumonia After LDCT n=114 Participants Clinician's estimates of high probability of pneumonia after LDCT chest scan
Number of Patients With Modified Diagnosis Probability After Low Dose CT (LDCT) Low probability of pneumonia before LDCT	10 Participants	3 Participants	4 Participants
Number of Patients With Modified Diagnosis Probability After Low Dose CT (LDCT) Intermediate probability of pneumonia before LDCT	34 Participants	13 Participants	23 Participants
Number of Patients With Modified Diagnosis Probability After Low Dose CT (LDCT) High probability of pneumonia before LDCT	13 Participants	13 Participants	87 Participants

SECONDARY outcome

Timeframe: At inclusion (during the first 72 hours after CT)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Low Probability of Pneumonia After LDCT n=127 Participants Clinician's estimates of low probability of pneumonia after LDCT chest scan	Intermediate Probability of Pneumonia After LDCT n=72 Participants Clinician's estimates of Intermediate probability of pneumonia after LDCT chest scans	High Probability of Pneumonia After LDCT Clinician's estimates of high probability of pneumonia after LDCT chest scan
Number of Bacterial and Viral Pulmonary Infections Positive PCR for virus	45 Participants	17 Participants	—
Number of Bacterial and Viral Pulmonary Infections Positive PCR for bacterial	50 Participants	23 Participants	—
Number of Bacterial and Viral Pulmonary Infections microbiologic routine methods	18 Participants	4 Participants	—

Adverse Events

Thoracic Low Dose CT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jerome Stirnemann

Hopitaux Universitaires de Geneve

Phone: +41223729101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place