Chest CT-scan for the Diagnosis of Community-acquired Pneumonia (PACSCAN)
Primary Purpose
Community-acquired Pneumonia, Dyspnea
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Chest CT-scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Community-acquired Pneumonia focused on measuring Community-acquired pneumonia, Diagnosis, Emergency medicine, Chest CT-scan
Eligibility Criteria
Inclusion Criteria:
- Patient above 18 years of age
- Patient with a presumptive diagnosis of CAP according to attending ED physician
- Patient experiencing at least one systemic sign (T°>38°C or < 36°C, HR>90/min, RR>20/min)
- Patient experiencing one respiratory sign (cough, lateral chest pain, localized crackles, dyspnea) that recently appeared
- Patient with a prior medical examination, the results have been or will be communicated
- Patient gave written informed consent or in cases of emergency parent/ support person who gave written informed consent if he/she is present on the day of inclusion
Exclusion Criteria:
- Pregnancy
- Patient with shock
- Patient with respiratory distress and immune suppression
- Patient with other criteria for immediate ICU referral to ICU
- Patient with living conditions making it impossible to follow 28 days
- Patient not affiliated with a social security system
Sites / Locations
- La Pitié Salpêtrière Hospital
- Cochin Hospital
- Bichat Hospital
- Tenon Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chest CT-scan
Arm Description
Patients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan
Outcomes
Primary Outcome Measures
Chest CT-scan
Percentage of diagnoses modified by chest CT-scan.
Secondary Outcome Measures
Treatments changes
Percentage of treatments changes (antimicrobial therapy) modified by chest CT-scan
Changes of site-of-care
Percentage of site-of-care (admission/non admission) modified by chest CT-scan
Identification of viral and bacterial agents
Identification of viral and bacterial agents from nasal and pharyngeal swabs
Markers of infection in the blood
Determination of markers of infection in the blood
Markers of infection and markers of inflammation in urine
Determination of markers of infection and of inflammation in urine
Full Information
NCT ID
NCT01574066
First Posted
February 7, 2012
Last Updated
August 1, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01574066
Brief Title
Chest CT-scan for the Diagnosis of Community-acquired Pneumonia
Acronym
PACSCAN
Official Title
Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary objective : to estimate impact of CT-scan on diagnostic for emergency department (ED) patients with suspected Community-acquired Pneumonia (CAP).
Secondary objective: to estimate impact of CT-scan on treatment (antimicrobial therapy) and site of care for ED patients with suspected CAP.
Detailed Description
Rational: Community-acquired pneumonia (CAP) is a frequent infectious disorder in patients visiting the ED. CAP is responsible for high morbidity and associated-mortality is increasing in Western countries. CAP corresponds to invasion of the lung by pathogens. Diagnosis depends on clinical and X-ray assessment. However, these signs and symptoms are poorly specific and are often lacking. As prognosis depends on precocious and fitted antimicrobial treatment, making CAP diagnosis in a short time span (4-8 hours) is mandatory. Preliminary studies suggest that chest CT-scan could over-performed X-ray for diagnosis of CAP. Consensus conferences suggest the use of CT-scan in patients with uncertain diagnosis and unusual presentation and outcome. Because CT-scan is currently easily available, its use in a first intent is questionable for ED patients with suspected CAP.
Primary objective: to estimate impact of CT-scan on diagnostic for ED patients with suspected CAP.
Secondary objective: to estimate impact of CT-scan on treatment (antimicrobial therapy) and site of care for ED patients with suspected CAP.
Prospective multicenter study to measure chest CT-scan impact. 350 patients visiting the ED of 4 inner tertiary teaching hospitals in Paris, France, with suspected CAP.
Management: Patients will be managed according to current guidelines, including conventional chest X-ray.
Evaluation criteria. Attending ED physicians will implement pre- and post-test proforma for diagnosis (CAP) level of certainty, treatment (antimicrobial agents), site of care, before and after chest CT-scan. Comparison of ED physician's answers before/after CT-scan. Patients will be followed until day 28. An adjudication committee (1 pneumologist, 1 infectiologist, 1 radiologist)will review patients' data for gold standard diagnosis.
Statistical considerations: The investigators hypothesize that chest CT-scan wil modify diagnosis certainty in 20%. This implies that 300 participants should be enrolled to allow assessment of changes in 15 % et 25 %. Undue changes will be calculated a posteriori when diagnosis gold standard will be established by adjudication committee.
Anticipated results: Chest CT-scan should improve diagnosis certainty, treatment and site-of-care in patients visiting the ED with suspected CAP. If this is observed in at least 20%, the investigators will measure impact of chest CT-scan in a prospective randomized interventional study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia, Dyspnea
Keywords
Community-acquired pneumonia, Diagnosis, Emergency medicine, Chest CT-scan
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
339 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chest CT-scan
Arm Type
Experimental
Arm Description
Patients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan
Intervention Type
Procedure
Intervention Name(s)
Chest CT-scan
Intervention Description
Patients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan
Primary Outcome Measure Information:
Title
Chest CT-scan
Description
Percentage of diagnoses modified by chest CT-scan.
Time Frame
in 28 days
Secondary Outcome Measure Information:
Title
Treatments changes
Description
Percentage of treatments changes (antimicrobial therapy) modified by chest CT-scan
Time Frame
in 28 days
Title
Changes of site-of-care
Description
Percentage of site-of-care (admission/non admission) modified by chest CT-scan
Time Frame
in 28 days
Title
Identification of viral and bacterial agents
Description
Identification of viral and bacterial agents from nasal and pharyngeal swabs
Time Frame
at day of inclusion (day 1)
Title
Markers of infection in the blood
Description
Determination of markers of infection in the blood
Time Frame
at day of inclusion (day 1)
Title
Markers of infection and markers of inflammation in urine
Description
Determination of markers of infection and of inflammation in urine
Time Frame
at day of inclusion (day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient above 18 years of age
Patient with a presumptive diagnosis of CAP according to attending ED physician
Patient experiencing at least one systemic sign (T°>38°C or < 36°C, HR>90/min, RR>20/min)
Patient experiencing one respiratory sign (cough, lateral chest pain, localized crackles, dyspnea) that recently appeared
Patient with a prior medical examination, the results have been or will be communicated
Patient gave written informed consent or in cases of emergency parent/ support person who gave written informed consent if he/she is present on the day of inclusion
Exclusion Criteria:
Pregnancy
Patient with shock
Patient with respiratory distress and immune suppression
Patient with other criteria for immediate ICU referral to ICU
Patient with living conditions making it impossible to follow 28 days
Patient not affiliated with a social security system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yann-Erick Claessens, MD, PhD
Organizational Affiliation
Cochin Hospital, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Pitié Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Bichat Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Tenon Hospital
City
Paris
ZIP/Postal Code
75020
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35758267
Citation
Tubiana S, Epelboin L, Casalino E, Naccache JM, Feydy A, Khalil A, Hausfater P, Duval X, Claessens YE; ESCAPED study group. Effect of diagnosis level of certainty on adherence to antibiotics' guidelines in ED patients with pneumonia: a post-hoc analysis of an interventional trial. Eur J Emerg Med. 2023 Apr 1;30(2):102-109. doi: 10.1097/MEJ.0000000000000954. Epub 2022 Jun 27.
Results Reference
derived
PubMed Identifier
31239315
Citation
Le Bel J, Pelaccia T, Ray P, Mayaud C, Brun AL, Hausfater P, Casalino E, Benjoar M, Claessens YE, Duval X; ESCAPED study group. Impact of emergency physician experience on decision-making in patients with suspected community-acquired pneumonia and undergoing systematic thoracic CT scan. Emerg Med J. 2019 Aug;36(8):485-492. doi: 10.1136/emermed-2018-207842. Epub 2019 Jun 24.
Results Reference
derived
PubMed Identifier
26472401
Citation
Le Bel J, Hausfater P, Chenevier-Gobeaux C, Blanc FX, Benjoar M, Ficko C, Ray P, Choquet C, Duval X, Claessens YE; ESCAPED study group. Diagnostic accuracy of C-reactive protein and procalcitonin in suspected community-acquired pneumonia adults visiting emergency department and having a systematic thoracic CT scan. Crit Care. 2015 Oct 16;19:366. doi: 10.1186/s13054-015-1083-6.
Results Reference
derived
PubMed Identifier
26168322
Citation
Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.
Results Reference
derived
PubMed Identifier
25704448
Citation
Das D, Le Floch H, Houhou N, Epelboin L, Hausfater P, Khalil A, Ray P, Duval X, Claessens YE, Leport C; ESCAPED Study Group. Viruses detected by systematic multiplex polymerase chain reaction in adults with suspected community-acquired pneumonia attending emergency departments in France. Clin Microbiol Infect. 2015 Jun;21(6):608.e1-8. doi: 10.1016/j.cmi.2015.02.014. Epub 2015 Feb 20.
Results Reference
derived
Learn more about this trial
Chest CT-scan for the Diagnosis of Community-acquired Pneumonia
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