Community-acquired PneumoniaPACSCANNCT01574066
Chest CT-scan for the Diagnosis of Community-acquired Pneumonia
A study testing Chest CT-scan in people with Community-acquired Pneumonia and Dyspnea, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Dyspnea
- What is being tested?
- Chest CT-scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
La Pitié Salpêtrière Hospital
Paris, 75013
Cochin Hospital
Paris, 75014
Bichat Hospital
Paris, 75018
Tenon Hospital
Paris, 75020
About this study
Official title: Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department
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.
Read the 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.
- Conditions
- Community-acquired Pneumonia, Dyspnea
- Being tested
- Chest CT-scan
- Keywords
- Community-acquired pneumonia, Diagnosis, Emergency medicine, Chest CT-scan
- Medical subject headings
- Community-Acquired Pneumonia, Dyspnea, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest CT-scanProcedure or surgery
Patients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan
| Study group | Role | What they receive |
|---|---|---|
| Chest CT-scan | Experimental | Patients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan Receives: Procedure: Chest CT-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest CT-scan
Percentage of diagnoses modified by chest CT-scan.
Measured: in 28 days
Secondary outcomes (5)
Treatments changes
Percentage of treatments changes (antimicrobial therapy) modified by chest CT-scan
Measured: in 28 days
Changes of site-of-care
Percentage of site-of-care (admission/non admission) modified by chest CT-scan
Measured: in 28 days
Identification of viral and bacterial agents
Identification of viral and bacterial agents from nasal and pharyngeal swabs
Measured: at day of inclusion (day 1)
Markers of infection in the blood
Determination of markers of infection in the blood
Measured: at day of inclusion (day 1)
Markers of infection and markers of inflammation in urine
Determination of markers of infection and of inflammation in urine
Measured: at day of inclusion (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yann-Erick Claessens, MD, PhD, Principal investigator, Cochin Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574066
- Sponsor's protocol ID
- AOM10014
- Other IDs
- P100121
- Acronym
- PACSCAN
- Status last verified
- Nov 2025
- First submitted
- 7 Feb 2012
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.
PubMed 26168322Le Bel J, Hausfater P, Chenevier-Gobeaux C, Blanc FX, Benjoar M, Ficko C, Ray P, Choquet C, Duval X, Claessens YE; ESCAPED study group. Diagnostic accuracy of C-reactive protein and procalcitonin in suspected community-acquired pneumonia adults visiting emergency department and having a systematic thoracic CT scan. Crit Care. 2015 Oct 16;19:366. doi: 10.1186/s13054-015-1083-6.
PubMed 26472401Das D, Le Floch H, Houhou N, Epelboin L, Hausfater P, Khalil A, Ray P, Duval X, Claessens YE, Leport C; ESCAPED Study Group. Viruses detected by systematic multiplex polymerase chain reaction in adults with suspected community-acquired pneumonia attending emergency departments in France. Clin Microbiol Infect. 2015 Jun;21(6):608.e1-8. doi: 10.1016/j.cmi.2015.02.014. Epub 2015 Feb 20.
PubMed 25704448Hofmeister J, Garin N, Montet X, Scheffler M, Platon A, Poletti PA, Stirnemann J, Debray MP, Claessens YE, Duval X, Prendki V. Validating the accuracy of deep learning for the diagnosis of pneumonia on chest x-ray against a robust multimodal reference diagnosis: a post hoc analysis of two prospective studies. Eur Radiol Exp. 2024 Feb 2;8(1):20. doi: 10.1186/s41747-023-00416-y.
PubMed 38302850Tubiana S, Epelboin L, Casalino E, Naccache JM, Feydy A, Khalil A, Hausfater P, Duval X, Claessens YE; ESCAPED study group. Effect of diagnosis level of certainty on adherence to antibiotics' guidelines in ED patients with pneumonia: a post-hoc analysis of an interventional trial. Eur J Emerg Med. 2023 Apr 1;30(2):102-109. doi: 10.1097/MEJ.0000000000000954. Epub 2022 Jun 27.
PubMed 35758267Le Bel J, Pelaccia T, Ray P, Mayaud C, Brun AL, Hausfater P, Casalino E, Benjoar M, Claessens YE, Duval X; ESCAPED study group. Impact of emergency physician experience on decision-making in patients with suspected community-acquired pneumonia and undergoing systematic thoracic CT scan. Emerg Med J. 2019 Aug;36(8):485-492. doi: 10.1136/emermed-2018-207842. Epub 2019 Jun 24.
PubMed 31239315
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department
- ClinicalTrials.gov ID
- NCT01574066
- Acronym / sponsor ID
- PACSCAN / AOM10014
- Conditions
- Community-acquired Pneumonia, Dyspnea
- Keywords
- Community-acquired pneumonia, Diagnosis, Emergency medicine, Chest CT-scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest CT-scan | Experimental | Procedure: Chest CT-scanPatients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest CT-scanPatients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan | Procedure or surgery | Chest CT-scan |
Primary outcome
Chest CT-scan
Time frame: in 28 days
Percentage of diagnoses modified by chest CT-scan.
5 secondary outcomes
Treatments changes
Time frame: in 28 days
Changes of site-of-care
Time frame: in 28 days
Identification of viral and bacterial agents
Time frame: at day of inclusion (day 1)
Markers of infection in the blood
Time frame: at day of inclusion (day 1)
Markers of infection and markers of inflammation in urine
Time frame: at day of inclusion (day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 26168322Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.
- Results publication: PubMed 26472401Le Bel J, Hausfater P, Chenevier-Gobeaux C, Blanc FX, Benjoar M, Ficko C, Ray P, Choquet C, Duval X, Claessens YE; ESCAPED study group. Diagnostic accuracy of C-reactive protein and procalcitonin in suspected community-acquired pneumonia adults visiting emergency department and having a systematic thoracic CT scan. Crit Care. 2015 Oct 16;19:366. doi: 10.1186/s13054-015-1083-6.
- Results publication: PubMed 25704448Das D, Le Floch H, Houhou N, Epelboin L, Hausfater P, Khalil A, Ray P, Duval X, Claessens YE, Leport C; ESCAPED Study Group. Viruses detected by systematic multiplex polymerase chain reaction in adults with suspected community-acquired pneumonia attending emergency departments in France. Clin Microbiol Infect. 2015 Jun;21(6):608.e1-8. doi: 10.1016/j.cmi.2015.02.014. Epub 2015 Feb 20.
- Derived from this study: PubMed 38302850Hofmeister J, Garin N, Montet X, Scheffler M, Platon A, Poletti PA, Stirnemann J, Debray MP, Claessens YE, Duval X, Prendki V. Validating the accuracy of deep learning for the diagnosis of pneumonia on chest x-ray against a robust multimodal reference diagnosis: a post hoc analysis of two prospective studies. Eur Radiol Exp. 2024 Feb 2;8(1):20. doi: 10.1186/s41747-023-00416-y.
- Derived from this study: PubMed 35758267Tubiana S, Epelboin L, Casalino E, Naccache JM, Feydy A, Khalil A, Hausfater P, Duval X, Claessens YE; ESCAPED study group. Effect of diagnosis level of certainty on adherence to antibiotics' guidelines in ED patients with pneumonia: a post-hoc analysis of an interventional trial. Eur J Emerg Med. 2023 Apr 1;30(2):102-109. doi: 10.1097/MEJ.0000000000000954. Epub 2022 Jun 27.
- Derived from this study: PubMed 31239315Le Bel J, Pelaccia T, Ray P, Mayaud C, Brun AL, Hausfater P, Casalino E, Benjoar M, Claessens YE, Duval X; ESCAPED study group. Impact of emergency physician experience on decision-making in patients with suspected community-acquired pneumonia and undergoing systematic thoracic CT scan. Emerg Med J. 2019 Aug;36(8):485-492. doi: 10.1136/emermed-2018-207842. Epub 2019 Jun 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yann-Erick Claessens, MD, PhD principal investigator
Cochin Hospital, Paris, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest CT-scan in people with Community-acquired Pneumonia and Dyspnea, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest CT-scan (time frame: in 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01574066, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.