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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574066

Locations
France
Bichat Hospital
Paris, France, 75018
Cochin Hospital
Paris, France, 75014
La Pitié Salpêtrière Hospital
Paris, France, 75013
Tenon Hospital
Paris, France, 75020
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:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 23, 2014