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

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ClinicalTrials.gov Identifier: NCT01574066
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE February 7, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date August 2, 2013
Study Start Date  ICMJE November 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
Chest CT-scan [ Time Frame: in 28 days ]
Percentage of diagnoses modified by chest CT-scan.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
  • Treatments changes [ Time Frame: in 28 days ]
    Percentage of treatments changes (antimicrobial therapy) modified by chest CT-scan
  • Changes of site-of-care [ Time Frame: in 28 days ]
    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) ]
    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) ]
    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) ]
    Determination of markers of infection and of inflammation in urine
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
  • Treatments changes [ Time Frame: in 28 days ]
    Percentage of treatments changes (antimicrobial therapy) modified by chest CT-scan
  • Changes of site-of-care [ Time Frame: in 28 days ]
    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) ]
    Identification of viral and bacterial agents from nasal swabs
  • Markers of infection in the blood [ Time Frame: at day of inclusion (day 1) ]
    Determination of markers of infection in the blood
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chest CT-scan for the Diagnosis of Community-acquired Pneumonia
Official Title  ICMJE Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Community-acquired Pneumonia
  • Dyspnea
Intervention  ICMJE Procedure: Chest CT-scan
Patients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan
Study Arms  ICMJE Experimental: Chest CT-scan
Patients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan
Intervention: Procedure: Chest CT-scan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2013)
339
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
350
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574066
Other Study ID Numbers  ICMJE AOM10014
P100121 ( Other Grant/Funding Number: AP-HP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yann-Erick Claessens, MD, PhD Cochin Hospital, Paris, France
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP