Hospital-acquired PneumoniaSHARPNCT04153682
Trial on a Strategy Combining Rapid Diagnostic Testing and Antimicrobial Stewardship to Improve Antibiotic Use in Patients With Hospital-acquired Pneumonia.
A study testing Rapid Diagnostic Testing and Antimicrobial stewardship in people with Hospital-acquired Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 8 sites in France.
Trial summary
Hospital-Acquired Pneumonia (HAP) is the second most frequent hospital-acquired infection in the US and Europe and accounts for a large proportion of antibiotics prescribed in hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital-acquired Pneumonia
- What is being tested?
- Rapid Diagnostic Testing and Antimicrobial stewardship
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 8 sitesFrance
- Study dates
- 21 Feb 2020to 31 Aug 2023
- 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
- Any patient hospitalized for ≥ 48 hours
- aged 18 years or older
- not mechanically-ventilated at time of onset of pneumonia symptoms
- Dated and signed inform consent - written informed consent of relative (trusted person, close family) in case of emergency procedure, by default emergency inclusion notified in medical file and pursuance consent sought
- Affiliation with a social security scheme
- Criteria of pneumonia:
- New lung infiltrate on a chest-x ray plus
- Evidence that the infiltrate is of an infectious origin, i.e. new onset of fever (> 38.5°C) and/or purulent sputum and/or leukocytosis and/or decline in oxygenation
Who cannot join
- Patients with severe chronic bronchitis structural changes: very severe COPD (Global initiative for chronic Obstructive Lung Disease GOLD 4), cystic fibrosis
- Radiological evidence of thoracic empyema, pulmonary abcess
- Patient life expectancy < 90 days
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Hôpitaux Universitaires Henri Mondor
Créteil, 94010
CHRU Nancy
Nancy, 54511
Hôpitaux Universitaires Paris Centre (Cochin) - service Médecine Intensive - Réanimation
Paris, 75006
Groupe Hospitalier Paris Saint Joseph
Paris, 75014
Hôpitaux Universitaires Paris Centre-Site Cochin
Paris, 75014
Hôpitaux Universitaires Paris Nord Val de Seine-Site Bichat (SMIT)
Paris, 75018
Hôpitaux Universitaires Paris Nord Val de Seine - EPRI (Bichat)
Paris
Hôpitaux Universitaires Paris Nord Val de Seine - MIR (Bichat)
Paris
About this study
Official title: Impact of a Strategy Combining the Rapid Polymerase Chain Reaction Platform FilmArray® and the Intervention of an Antimicrobial Stewardship Team in Hospital-acquired Pneumonia : a Randomized Controlled Trial.
Hospital-Acquired Pneumonia (HAP) is the second most frequent hospital-acquired infection in the US and Europe and accounts for a large proportion of antibiotics prescribed in hospitals. Conventional methods to identify causative microorganisms (virus, bacteria) are time-consuming and sometimes inaccurate, leading to inadequate treatment in a large proportion of HAP patients.
The FILMARRAY® Pneumonia Panel (FA-PP, bioMérieux) is an automated diagnostic device, allowing detection of multiple pathogens and resistance markers in one hour. Strategies combining rapid diagnostic testing and intervention of specialists in infectious diseases (i.e. antimicrobial stewardship -AMS - experts) showed significant synergistic impact on antibiotic use, mortality and costs in bloodstream infections.
Read more
The trial hypothesis is that a strategy combining antimicrobial stewardship and FA-PP improves quality of care in HAP patients, as compared to antimicrobial stewardship alone.
The trial will include patients hospitalized for ≥ 48 hours, aged 18 years or older, who have criteria of pneumonia: new lung infiltrate on a chest-x ray, plus evidence that the infiltrate is of an infectious origin (i.e. new onset of fever and/or purulent sputum and/or leukocytosis and/or decline in oxygenation).
After informed consent, participants will be randomly allocated to either the intervention or the control arm.
In the control arm, management of HAP patients will include clinical examination and conventional microbiological tests. Antibiotic choice will be discussed between AMS experts and the physician in charge of the patient.
In the intervention arm, in addition to the procedures above, the strategy will include rapid testing using the FA-PP on a respiratory specimen, obtained by either invasive or non-invasive sampling. No additional invasive procedures will be required for the study, and FA-PP will be performed on samples collected as part as routine care.
Investigators will visit the patient at inclusion, on day 3 and on day 30 (or at hospital discharge) to collect data on comorbidities, clinical outcomes, results of microbiological tests and antibiotics. At the end of follow-up, we will compare the number of days on broad-spectrum antibiotics, the incidence of negative outcomes, the length of stay and costs in the two arms.
The use of the FA-PP is expected to prompt early adjustment of antibiotic therapy, improve outcomes, decrease length of stay, and to reduce the use of broad-spectrum antibiotics. The antibiotic saving may reduce the selection pressure, incidence of colonization with multidrug-resistant bacteria and incidence of hospital-acquired superinfections, both at an individual and hospital level. Moreover, this trial relies on the intervention of multidisciplinary AMS teams that are currently being implemented in many health facilities. Their transversal position offers opportunities for recruitment of patients from a wide range of medical and surgical departments. This project evaluates the feasibility of clinical trials based on the intervention of these teams, and will provide a high level of evidence regarding their impact on the prognosis of patients, appropriate use of antibiotics, and antimicrobial resistance.
- Conditions
- Hospital-acquired Pneumonia
- Being tested
- Rapid Diagnostic Testing, Antimicrobial stewardship
- Keywords
- Antimicrobial stewardship, hospital-acquired pneumonia, syndromic approach, rapid diagnostic testing
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Diagnostic TestingDiagnostic test
Also called Filmarray® Pneumonia Panel (FA-PP)
Automated microbiological diagnostic device based on multiplex PCR analysis, allowing detection of multiple pathogens and resistance markers in one hour from invasive and non-invasive respiratory samples
Antimicrobial stewardshipDiagnostic test
Also called AMS
After clinical examination, routine biological tests will be performed. This includes blood culture, direct examination and culture of invasive or noninvasive respiratory samples, urinary antigen tests for Legionella and Pneumococcus, Influenza PCR on nasopharyngeal swabs (during the influenza season).
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial stewardship (= AMS) | Active comparator | Management of HAP according to current practice, including intervention of the AMS team. Receives: Diagnostic Test: Antimicrobial stewardship |
| Antimicrobial Stewardship + Rapid Diagnostic Testing | Experimental | Management of HAP including rapid diagnostic testing (FA-PP) and intervention of the AMS team. Receives: Diagnostic Test: Rapid Diagnostic Testing; Diagnostic Test: Antimicrobial stewardship |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days on broad-spectrum antibiotics at day 30 or end-of follow-up for 100 patients-days
Number of days that a patient is on an antibiotic, regardless of dose. The list of broad-spectrum antibiotics was defined according to previous literature data.
Measured: Day 30 or hospital discharge (plus or minus 4 days)
Secondary outcomes (7)
Overall antibiotic use
Number of days on antibiotics per 100 patient-days
Measured: Day 30 or hospital discharge (plus or minus 4 days)
Duration of antibiotics for the HAP episode
Number of days on any antibiotic for the HAP episode
Measured: up to 30 days
Mortality
Measured: up to 30 days
In-hospital length of stay
Number of days between admission and discharge
Measured: up to 24 weeks
Incidence of Clostridium difficile colitis
Number of patients with documented Clostridium difficile colitis per 100 patient-days.
Clostridium difficile colitis is defined by clinical evidence of colitis (unexplained and new-onset ≥3 unformed stools) and positive microbiological test relying on the multistep algorithm routinely used in each investigating center and compliant with national and international standards.
Measured: Day 30 or hospital discharge (plus or minus 4 days)
Medical direct costs
Costs of the FILMARRAY® Pneumonia panel (labor and consumables), Antibiotic costs, Total admission costs
Measured: Day 30 or hospital discharge (plus or minus 4 days)
Analytical performances of the FILMARRAY® Pneumonia panel compared to conventional methods
Number of discrepancies on Micro-organism identification and Antibiotic resistance
Measured: End of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start21 Feb 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hospital-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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 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
- Solen Kernéis, MD, PhD, Principal investigator, Antimicrobial Stewardship Team, Hôpitaux Universitaires Paris Centre, Université de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153682
- Sponsor's protocol ID
- APHP180391
- Acronym
- SHARP
- Status last verified
- Oct 2025
- First submitted
- 2 Sep 2019
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14.
PubMed 27418577Messika J, Stoclin A, Bouvard E, Fulgencio JP, Ridel C, Muresan IP, Boffa JJ, Bachmeyer C, Denis M, Gounant V, Esteso A, Loi V, Verdet C, Prigent H, Parrot A, Fartoukh M. The Challenging Diagnosis of Non-Community-Acquired Pneumonia in Non-Mechanically Ventilated Subjects: Value of Microbiological Investigation. Respir Care. 2016 Feb;61(2):225-34. doi: 10.4187/respcare.04143. Epub 2015 Dec 8.
PubMed 26647452Gadsby NJ, Russell CD, McHugh MP, Mark H, Conway Morris A, Laurenson IF, Hill AT, Templeton KE. Comprehensive Molecular Testing for Respiratory Pathogens in Community-Acquired Pneumonia. Clin Infect Dis. 2016 Apr 1;62(7):817-823. doi: 10.1093/cid/civ1214. Epub 2016 Jan 7.
PubMed 26747825Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD003543. doi: 10.1002/14651858.CD003543.pub4.
PubMed 28178770Bookstaver PB, Nimmich EB, Smith TJ 3rd, Justo JA, Kohn J, Hammer KL, Troficanto C, Albrecht HA, Al-Hasan MN. Cumulative Effect of an Antimicrobial Stewardship and Rapid Diagnostic Testing Bundle on Early Streamlining of Antimicrobial Therapy in Gram-Negative Bloodstream Infections. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e00189-17. doi: 10.1128/AAC.00189-17. Print 2017 Sep.
PubMed 28630187Kerneis S, Canoui E, Deconinck L, Dlela M, Valade S, Lortat-Jacob B, Ollivier C, Kardas-Sloma L, Charpentier J, Loubinoux J, Pilmis B, Mizrahi A, Lepeule R, Decousser JW, Bercot B, Poyart C, Lescure FX, Montravers P, Azoulay E, Durand-Zaleski I, Abdoul H, Timsit JF, Armand-Lefevre L; SHARP study group; SHARP study group. PCR-based syndromic tests for antibiotic stewardship in non-ventilated patients with hospital-acquired pneumonia: a multicentre randomized controlled trial. JAC Antimicrob Resist. 2026 Jul 30;8(4):dlag154. doi: 10.1093/jacamr/dlag154. eCollection 2026 Aug.
PubMed 42534393Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713.
PubMed 33395094
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Strategy Combining the Rapid Polymerase Chain Reaction Platform FilmArray® and the Intervention of an Antimicrobial Stewardship Team in Hospital-acquired Pneumonia : a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04153682
- Acronym / sponsor ID
- SHARP / APHP180391
- Conditions
- Hospital-acquired Pneumonia
- Keywords
- Antimicrobial stewardship, hospital-acquired pneumonia, syndromic approach, rapid diagnostic testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 6 Nov 2019 (actual)
- 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.
Hospital-Acquired Pneumonia (HAP) is the second most frequent hospital-acquired infection in the US and Europe and accounts for a large proportion of antibiotics prescribed in hospitals. Conventional methods to identify causative microorganisms (virus, bacteria) are time-consuming and sometimes inaccurate, leading to inadequate treatment in a large proportion of HAP patients.
The FILMARRAY® Pneumonia Panel (FA-PP, bioMérieux) is an automated diagnostic device, allowing detection of multiple pathogens and resistance markers in one hour. Strategies combining rapid diagnostic testing and intervention of specialists in infectious diseases (i.e. antimicrobial stewardship -AMS - experts) showed significant synergistic impact on antibiotic use, mortality and costs in bloodstream infections.
The trial hypothesis is that a strategy combining antimicrobial stewardship and FA-PP improves quality of care in HAP patients, as compared to antimicrobial stewardship alone.
The trial will include patients hospitalized for ≥ 48 hours, aged 18 years or older, who have criteria of pneumonia: new lung infiltrate on a chest-x ray, plus evidence that the infiltrate is of an infectious origin (i.e. new onset of fever and/or purulent sputum and/or leukocytosis and/or decline in oxygenation).
After informed consent, participants will be randomly allocated to either the intervention or the control arm.
In the control arm, management of HAP patients will include clinical examination and conventional microbiological tests. Antibiotic choice will be discussed between AMS experts and the physician in charge of the patient.
In the intervention arm, in addition to the procedures above, the strategy will include rapid testing using the FA-PP on a respiratory specimen, obtained by either invasive or non-invasive sampling. No additional invasive procedures will be required for the study, and FA-PP will be performed on samples collected as part as routine care.
Investigators will visit the patient at inclusion, on day 3 and on day 30 (or at hospital discharge) to collect data on comorbidities, clinical outcomes, results of microbiological tests and antibiotics. At the end of follow-up, we will compare the number of days on broad-spectrum antibiotics, the incidence of negative outcomes, the length of stay and costs in the two arms.
The use of the FA-PP is expected to prompt early adjustment of antibiotic therapy, improve outcomes, decrease length of stay, and to reduce the use of broad-spectrum antibiotics. The antibiotic saving may reduce the selection pressure, incidence of colonization with multidrug-resistant bacteria and incidence of hospital-acquired superinfections, both at an individual and hospital level. Moreover, this trial relies on the intervention of multidisciplinary AMS teams that are currently being implemented in many health facilities. Their transversal position offers opportunities for recruitment of patients from a wide range of medical and surgical departments. This project evaluates the feasibility of clinical trials based on the intervention of these teams, and will provide a high level of evidence regarding their impact on the prognosis of patients, appropriate use of antibiotics, and antimicrobial resistance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial stewardship (= AMS) | Active comparator | Diagnostic Test: Antimicrobial stewardshipManagement of HAP according to current practice, including intervention of the AMS team. |
| Antimicrobial Stewardship + Rapid Diagnostic Testing | Experimental | Diagnostic Test: Rapid Diagnostic Testing, Diagnostic Test: Antimicrobial stewardshipManagement of HAP including rapid diagnostic testing (FA-PP) and intervention of the AMS team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Any patient hospitalized for ≥ 48 hours
- aged 18 years or older
- not mechanically-ventilated at time of onset of pneumonia symptoms
- Dated and signed inform consent - written informed consent of relative (trusted person, close family) in case of emergency procedure, by default emergency inclusion notified in medical file and pursuance consent sought
- Affiliation with a social security scheme
Key exclusion criteria (3 listed)
- Patients with severe chronic bronchitis structural changes: very severe COPD (Global initiative for chronic Obstructive Lung Disease GOLD 4), cystic fibrosis
- Radiological evidence of thoracic empyema, pulmonary abcess
- Patient life expectancy < 90 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 |
|---|---|---|
| Rapid Diagnostic TestingAlso: Filmarray® Pneumonia Panel (FA-PP)Automated microbiological diagnostic device based on multiplex PCR analysis, allowing detection of multiple pathogens and resistance markers in one hour from invasive and non-invasive respiratory samples | Diagnostic test | Antimicrobial Stewardship + Rapid Diagnostic Testing |
| Antimicrobial stewardshipAlso: AMSAfter clinical examination, routine biological tests will be performed. This includes blood culture, direct examination and culture of invasive or noninvasive respiratory samples, urinary antigen tests for Legionella and Pneumococcus, Influenza PCR on nasopharyngeal swabs (during the influenza season). | Diagnostic test | Antimicrobial Stewardship + Rapid Diagnostic Testing, Antimicrobial stewardship (= AMS) |
Primary outcome
Number of days on broad-spectrum antibiotics at day 30 or end-of follow-up for 100 patients-days
Time frame: Day 30 or hospital discharge (plus or minus 4 days)
Number of days that a patient is on an antibiotic, regardless of dose. The list of broad-spectrum antibiotics was defined according to previous literature data.
7 secondary outcomes
Overall antibiotic use
Time frame: Day 30 or hospital discharge (plus or minus 4 days)
Duration of antibiotics for the HAP episode
Time frame: up to 30 days
Mortality
Time frame: up to 30 days
In-hospital length of stay
Time frame: up to 24 weeks
Incidence of Clostridium difficile colitis
Time frame: Day 30 or hospital discharge (plus or minus 4 days)
Medical direct costs
Time frame: Day 30 or hospital discharge (plus or minus 4 days)
Analytical performances of the FILMARRAY® Pneumonia panel compared to conventional methods
Time frame: End of the study
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 12 Aug 2026.
- Background: PubMed 27418577Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14.
- Background: PubMed 26647452Messika J, Stoclin A, Bouvard E, Fulgencio JP, Ridel C, Muresan IP, Boffa JJ, Bachmeyer C, Denis M, Gounant V, Esteso A, Loi V, Verdet C, Prigent H, Parrot A, Fartoukh M. The Challenging Diagnosis of Non-Community-Acquired Pneumonia in Non-Mechanically Ventilated Subjects: Value of Microbiological Investigation. Respir Care. 2016 Feb;61(2):225-34. doi: 10.4187/respcare.04143. Epub 2015 Dec 8.
- Background: PubMed 26747825Gadsby NJ, Russell CD, McHugh MP, Mark H, Conway Morris A, Laurenson IF, Hill AT, Templeton KE. Comprehensive Molecular Testing for Respiratory Pathogens in Community-Acquired Pneumonia. Clin Infect Dis. 2016 Apr 1;62(7):817-823. doi: 10.1093/cid/civ1214. Epub 2016 Jan 7.
- Background: PubMed 28178770Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD003543. doi: 10.1002/14651858.CD003543.pub4.
- Background: PubMed 28630187Bookstaver PB, Nimmich EB, Smith TJ 3rd, Justo JA, Kohn J, Hammer KL, Troficanto C, Albrecht HA, Al-Hasan MN. Cumulative Effect of an Antimicrobial Stewardship and Rapid Diagnostic Testing Bundle on Early Streamlining of Antimicrobial Therapy in Gram-Negative Bloodstream Infections. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e00189-17. doi: 10.1128/AAC.00189-17. Print 2017 Sep.
- Results publication: PubMed 42534393Kerneis S, Canoui E, Deconinck L, Dlela M, Valade S, Lortat-Jacob B, Ollivier C, Kardas-Sloma L, Charpentier J, Loubinoux J, Pilmis B, Mizrahi A, Lepeule R, Decousser JW, Bercot B, Poyart C, Lescure FX, Montravers P, Azoulay E, Durand-Zaleski I, Abdoul H, Timsit JF, Armand-Lefevre L; SHARP study group; SHARP study group. PCR-based syndromic tests for antibiotic stewardship in non-ventilated patients with hospital-acquired pneumonia: a multicentre randomized controlled trial. JAC Antimicrob Resist. 2026 Jul 30;8(4):dlag154. doi: 10.1093/jacamr/dlag154. eCollection 2026 Aug.
- Derived from this study: PubMed 33395094Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713.
- Individual participant dataSharing planned: Undecided
Related trials for Hospital-acquired Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 1
A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
Recruiting
Nosocomial Respiratory Virus Infection
Nosocomial Infections
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.
Solen Kernéis, MD, PhD principal investigator
Antimicrobial Stewardship Team, Hôpitaux Universitaires Paris Centre, Université de Paris
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Diagnostic Testing and Antimicrobial stewardship in people with Hospital-acquired Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 8 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 8 inclusion and 3 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Number of days on broad-spectrum antibiotics at day 30 or end-of follow-up for 100 patients-days (time frame: Day 30 or hospital discharge (plus or minus 4 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 NCT04153682, which also lists 7 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 12 Aug 2026.