Trial on a Strategy Combining Rapid Diagnostic Testing and Antimicrobial Stewardship to Improve Antibiotic Use in Patients With Hospital-acquired Pneumonia.

NCT04153682 | Completed

• 1 other identifier: APHP180391
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 8

Brief 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. 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.

Conditions

Hospital-acquired Pneumonia

Keywords

Antimicrobial stewardship; hospital-acquired pneumonia; syndromic approach; rapid diagnostic testing

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 30 or hospital discharge (plus or minus 4 days)

Secondary Outcomes (7)

• Overall antibiotic use

  Day 30 or hospital discharge (plus or minus 4 days)

• Duration of antibiotics for the HAP episode

  up to 30 days

• Mortality

  up to 30 days

• In-hospital length of stay

  up to 24 weeks

• Incidence of Clostridium difficile colitis

  Day 30 or hospital discharge (plus or minus 4 days)

Study Arms (2)

Antimicrobial stewardship (= AMS)

ACTIVE COMPARATOR

Management of HAP according to current practice, including intervention of the AMS team.

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.

Diagnostic Test: Rapid Diagnostic Testing; Diagnostic Test: Antimicrobial stewardship

Interventions

Rapid Diagnostic Testing DIAGNOSTIC_TEST

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

Also known as: Filmarray® Pneumonia Panel (FA-PP)

Antimicrobial Stewardship + Rapid Diagnostic Testing

Antimicrobial stewardship DIAGNOSTIC_TEST

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).

Also known as: AMS

Antimicrobial Stewardship + Rapid Diagnostic Testing; Antimicrobial stewardship (= AMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient hospitalized for ≥ 48 hours
• aged 18 years or older
• not mechanically-ventilated at time of onset of pneumonia symptoms
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (8)

Hôpitaux Universitaires Henri Mondor

Créteil, 94010, France

Location

CHRU Nancy

Nancy, 54511, France

Location

Hôpitaux Universitaires Paris Centre (Cochin) - service Médecine Intensive - Réanimation

Paris, 75006, France

Location

Groupe Hospitalier Paris Saint Joseph

Paris, 75014, France

Location

Hôpitaux Universitaires Paris Centre-Site Cochin

Paris, 75014, France

Location

Hôpitaux Universitaires Paris Nord Val de Seine-Site Bichat (SMIT)

Paris, 75018, France

Location

Hôpitaux Universitaires Paris Nord Val de Seine - EPRI (Bichat)

Paris, France

Location

Hôpitaux Universitaires Paris Nord Val de Seine - MIR (Bichat)

Paris, France

Location

Related Publications (6)

• 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.

  PMID: 27418577 BACKGROUND

• Messika 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.

  PMID: 26647452 BACKGROUND

• Gadsby 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.

  PMID: 26747825 BACKGROUND

• Davey 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.

  PMID: 28178770 BACKGROUND

• Bookstaver 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.

  PMID: 28630187 BACKGROUND

• Kerneis 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.

  PMID: 33395094 DERIVED

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Solen Kernéis, MD, PhD

  Antimicrobial Stewardship Team, Hôpitaux Universitaires Paris Centre, Université de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: November 6, 2019
• Study Start: February 21, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (8)