Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Community-acquired Pneumonia
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 339
- Locations
- 4
- Primary Endpoint
- Chest CT-scan
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Chest CT-scan
Time Frame: in 28 days
Percentage of diagnoses modified by chest CT-scan.
Secondary Outcomes
- Treatments changes(in 28 days)
- Changes of site-of-care(in 28 days)
- Identification of viral and bacterial agents(at day of inclusion (day 1))
- Markers of infection in the blood(at day of inclusion (day 1))
- Markers of infection and markers of inflammation in urine(at day of inclusion (day 1))