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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Dyspnea Procedure: Chest CT-scan Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department
Study Start Date : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Chest CT-scan [ Time Frame: in 28 days ]
    Percentage of diagnoses modified by chest CT-scan.


Secondary Outcome Measures :
  1. Treatments changes [ Time Frame: in 28 days ]
    Percentage of treatments changes (antimicrobial therapy) modified by chest CT-scan

  2. Changes of site-of-care [ Time Frame: in 28 days ]
    Percentage of site-of-care (admission/non admission) modified by chest CT-scan

  3. 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

  4. Markers of infection in the blood [ Time Frame: at day of inclusion (day 1) ]
    Determination of markers of infection in the blood

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574066


Locations
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France
La Pitié Salpêtrière Hospital
Paris, France, 75013
Cochin Hospital
Paris, France, 75014
Bichat Hospital
Paris, France, 75018
Tenon Hospital
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Yann-Erick Claessens, MD, PhD Cochin Hospital, Paris, France
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01574066    
Other Study ID Numbers: AOM10014
P100121 ( Other Grant/Funding Number: AP-HP )
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: July 2013
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Community-acquired pneumonia
Diagnosis
Emergency medicine
Chest CT-scan
Additional relevant MeSH terms:
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Pneumonia
Dyspnea
Respiratory Tract Infections
Infections
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory