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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01574066

Collaborator

(none)

339

Enrollment

Locations

Arm

Duration (Months)

84.8

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia Dyspnea	Procedure: Chest CT-scan	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

339 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chest CT-scan Patients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan	Procedure: Chest CT-scan Patients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan

Arm

Intervention/Treatment

Experimental: Chest CT-scan

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

Procedure: Chest CT-scan

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

Outcome Measures

Primary Outcome Measures

Chest CT-scan [in 28 days]
Percentage of diagnoses modified by chest CT-scan.

Secondary Outcome Measures

Treatments changes [in 28 days]
Percentage of treatments changes (antimicrobial therapy) modified by chest CT-scan
Changes of site-of-care [in 28 days]
Percentage of site-of-care (admission/non admission) modified by chest CT-scan
Identification of viral and bacterial agents [at day of inclusion (day 1)]
Identification of viral and bacterial agents from nasal and pharyngeal swabs
Markers of infection in the blood [at day of inclusion (day 1)]
Determination of markers of infection in the blood
Markers of infection and markers of inflammation in urine [at day of inclusion (day 1)]
Determination of markers of infection and of inflammation in urine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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