Trial on a Strategy Combining Rapid Diagnostic Testing and Antimicrobial Stewardship to Improve Antibiotic Use in Patients with Hospital-acquired Pneumonia.
- Conditions
- Hospital-acquired Pneumonia
- Interventions
- Diagnostic Test: Rapid Diagnostic TestingDiagnostic Test: Antimicrobial stewardship
- Registration Number
- NCT04153682
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antimicrobial Stewardship + Rapid Diagnostic Testing Rapid Diagnostic Testing Management of HAP including rapid diagnostic testing (FA-PP) and intervention of the AMS team. Antimicrobial stewardship (= AMS) Antimicrobial stewardship Management of HAP according to current practice, including intervention of the AMS team. Antimicrobial Stewardship + Rapid Diagnostic Testing Antimicrobial stewardship Management of HAP including rapid diagnostic testing (FA-PP) and intervention of the AMS team.
- Primary Outcome Measures
Name Time Method Number of days on broad-spectrum antibiotics at day 30 or end-of follow-up for 100 patients-days 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.
- Secondary Outcome Measures
Name Time Method Analytical performances of the FILMARRAY® Pneumonia panel compared to conventional methods End of the study Number of discrepancies on Micro-organism identification and Antibiotic resistance
Medical direct costs Day 30 or hospital discharge (plus or minus 4 days) Costs of the FILMARRAY® Pneumonia panel (labor and consumables), Antibiotic costs, Total admission costs
Duration of antibiotics for the HAP episode up to 30 days Number of days on any antibiotic for the HAP episode
In-hospital length of stay up to 24 weeks Number of days between admission and discharge
Overall antibiotic use Day 30 or hospital discharge (plus or minus 4 days) Number of days on antibiotics per 100 patient-days
Incidence of Clostridium difficile colitis 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.Mortality up to 30 days
Trial Locations
- Locations (8)
Hôpitaux Universitaires Henri Mondor
🇫🇷Créteil, France
CHRU Nancy
🇫🇷Nancy, France
Hôpitaux Universitaires Paris Centre (Cochin) - service Médecine Intensive - Réanimation
🇫🇷Paris, France
Groupe Hospitalier Paris Saint Joseph
🇫🇷Paris, France
Hôpitaux Universitaires Paris Centre-Site Cochin
🇫🇷Paris, France
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)
🇫🇷Paris, France