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

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Dyspnea

Community-acquired Pneumonia

Treatments

Procedure: Chest CT-scan

Study type

Interventional

Funder types

Other

Identifiers

NCT01574066

P100121 (Other Grant/Funding Number)

AOM10014

Details and patient eligibility

About

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.

Full 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.

Enrollment

339 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Exclusion criteria