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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01574066
First received: February 7, 2012
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

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 Intervention
Community-acquired Pneumonia
Dyspnea
Procedure: Chest CT-scan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Chest CT-scan [ Time Frame: in 28 days ] [ Designated as safety issue: No ]
    Percentage of diagnoses modified by chest CT-scan.


Secondary Outcome Measures:
  • Treatments changes [ Time Frame: in 28 days ] [ Designated as safety issue: No ]
    Percentage of treatments changes (antimicrobial therapy) modified by chest CT-scan

  • Changes of site-of-care [ Time Frame: in 28 days ] [ Designated as safety issue: No ]
    Percentage of site-of-care (admission/non admission) modified by chest CT-scan

  • Identification of viral and bacterial agents [ Time Frame: at day of inclusion (day 1) ] [ Designated as safety issue: No ]
    Identification of viral and bacterial agents from nasal and pharyngeal swabs

  • Markers of infection in the blood [ Time Frame: at day of inclusion (day 1) ] [ Designated as safety issue: No ]
    Determination of markers of infection in the blood

  • Markers of infection and markers of inflammation in urine [ Time Frame: at day of inclusion (day 1) ] [ Designated as safety issue: No ]
    Determination of markers of infection and of inflammation in urine


Enrollment: 339
Study Start Date: November 2011
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574066

Locations
France
Cochin Hospital
Paris, France, 75014
La Pitié Salpêtrière Hospital
Paris, France, 75013
Tenon Hospital
Paris, France, 75020
Bichat Hospital
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Yann-Erick Claessens, MD, PhD Cochin Hospital, Paris, France
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01574066     History of Changes
Other Study ID Numbers: AOM10014, P100121
Study First Received: February 7, 2012
Last Updated: August 1, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Community-acquired pneumonia
Diagnosis
Emergency medicine
Chest CT-scan

Additional relevant MeSH terms:
Dyspnea
Pneumonia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 16, 2014