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

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94010
        • Hôpitaux Universitaires Henri Mondor
      • Nancy, France, 54511
        • Chru Nancy
      • Paris, France, 75014
        • Groupe hospitalier Paris saint Joseph
      • Paris, France, 75006
        • Hôpitaux Universitaires Paris Centre (Cochin) - service Médecine Intensive - Réanimation
      • Paris, France, 75014
        • Hôpitaux Universitaires Paris Centre-Site Cochin
      • Paris, France, 75018
        • Hôpitaux Universitaires Paris Nord Val de Seine-Site Bichat (SMIT)
      • Paris, France
        • Hôpitaux Universitaires Paris Nord Val de Seine - EPRI (Bichat)
      • Paris, France
        • Hôpitaux Universitaires Paris Nord Val de Seine - MIR (Bichat)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antimicrobial stewardship (= AMS)
Management of HAP according to current practice, including intervention of the AMS team.
Diagnostic test: Antimicrobial stewardship
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).
Other Names:
  • AMS
Experimental: Antimicrobial Stewardship + Rapid Diagnostic Testing
Management of HAP including rapid diagnostic testing (FA-PP) and intervention of the AMS team.
Diagnostic test: Antimicrobial stewardship
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).
Other Names:
  • AMS
Diagnostic test: Rapid Diagnostic Testing
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
Other Names:
  • Filmarray® Pneumonia Panel (FA-PP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 30 or hospital discharge (plus or minus 4 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall antibiotic use
Time Frame: Day 30 or hospital discharge (plus or minus 4 days)
Number of days on antibiotics per 100 patient-days
Day 30 or hospital discharge (plus or minus 4 days)
Duration of antibiotics for the HAP episode
Time Frame: up to 30 days
Number of days on any antibiotic for the HAP episode
up to 30 days
Mortality
Time Frame: up to 30 days
up to 30 days
In-hospital length of stay
Time Frame: up to 24 weeks
Number of days between admission and discharge
up to 24 weeks
Incidence of Clostridium difficile colitis
Time Frame: Day 30 or hospital discharge (plus or minus 4 days)

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.
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)
Costs of the FILMARRAY® Pneumonia panel (labor and consumables), Antibiotic costs, Total admission costs
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
Number of discrepancies on Micro-organism identification and Antibiotic resistance
End of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Solen Kernéis, MD, PhD, Antimicrobial Stewardship Team, Hôpitaux Universitaires Paris Centre, Université de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2020

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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