Ignite Creation Date:
2024-05-06 @ 12:26 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01574066
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2012-02-07
Brief Title:
Chest CT-scan for the Diagnosis of Community-acquired Pneumonia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACSCAN
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
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 physicians answers beforeafter CT-scan Patients will be followed until day 28 An adjudication committee 1 pneumologist 1 infectiologist 1 radiologistwill 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
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 physicians answers beforeafter CT-scan Patients will be followed until day 28 An adjudication committee 1 pneumologist 1 infectiologist 1 radiologistwill 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P100121 | OTHER_GRANT | AP-HP | None |