Chest CT-scan for the Diagnosis of Community-acquired Pneumonia

Dyspnea Clinical Trial

— PACSCAN  

Official title:

Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574066
• Other study ID #: AOM10014
• Secondary ID: P100121
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: August 1, 2013
• Start date: November 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Dyspnea
• Pneumonia

Intervention

Procedure:
• Chest CT-scan
Patients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan

Locations

Country	Name	City	State
France	Bichat Hospital	Paris
France	Cochin Hospital	Paris
France	La Pitié Salpêtrière Hospital	Paris
France	Tenon Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest CT-scan	Percentage of diagnoses modified by chest CT-scan.	in 28 days	No
Secondary	Treatments changes	Percentage of treatments changes (antimicrobial therapy) modified by chest CT-scan	in 28 days	No
Secondary	Changes of site-of-care	Percentage of site-of-care (admission/non admission) modified by chest CT-scan	in 28 days	No
Secondary	Identification of viral and bacterial agents	Identification of viral and bacterial agents from nasal and pharyngeal swabs	at day of inclusion (day 1)	No
Secondary	Markers of infection in the blood	Determination of markers of infection in the blood	at day of inclusion (day 1)	No
Secondary	Markers of infection and markers of inflammation in urine	Determination of markers of infection and of inflammation in urine	at day of inclusion (day 1)	No