ADEQUATE Advanced Diagnostics for Enhanced Quality of Antibiotic Prescription

NCT ID: NCT04547556

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2022-05-21

Brief Summary

To assess the impact of rapid diagnostic testing of patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antimicrobial prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome. Geographical and seasonal variation will be assessed on a real time basis including pathogens of public health interest. The impact will be stratified within age groups and risk factors in order to determine the long-term clinical, public health and economic determinants for the integration of diagnostics in a global and sustainable perspective.

Detailed Description

Objective: To assess the impact of rapid diagnostic testing of patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antibiotic prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome. Geographical and seasonal variation will be assessed on a real time basis including pathogens of public health interest. The impact will be stratified within age groups and risk factors in order to determine the long-term clinical, public health and economic determinants for the integration of diagnostics in a global and sustainable perspective.

Study design: Prospective, multi-center, individually randomised, controlled trial.

Study population: Adults (≥18 years old) consulting in selected participating sites with CA-ARTI.

Study Intervention: The diagnostic intervention is rapid syndromic testing with:

• BioFire FilmArray Pneumonia Panel plus (PP): Sputum (and/or ETA or BAL sample)
• BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus): Nasopharyngeal swab

Main study parameters/endpoints:

• Days alive out of hospital (superiority endpoint), within 14 days
• Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days
• Adverse outcome (non-inferiority safety endpoint)

• For initially non-admitted patients: any admission or death within 30 days
• For initially hospitalised patients: i) any readmission, ii) ICU admission ≥ 24 hours after hospitalisation, or iii) death within 30 days Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in the study involves collection of data that can be obtained from medical charts and follow up questionnaires and interviews. Respiratory samples (e.g. nasopharyngeal swab, sputum) will be obtained as standard of care and diagnostic intervention (Biofire FilmArray) will be used only for participants randomised to the intervention,Based on the results of diagnostic testing (BioFire FilmArray) antibiotics may be withheld when deemed unnecessary, or a different antibiotic class may be selected when certain bacterial pathogens are detected. The risks and benefits of management decisions, complemented with adequate training, are subject to the current investigation.

Conditions

Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention

Diagnostic intervention

Group Type: EXPERIMENTAL

BioFire

Intervention Type: DIAGNOSTIC_TEST

A molecular rapid syndromic testing platform, using the following panels:

• BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)
• BioFire FilmArray Pneumonia Panel plus (PP)

Standard of Care

Standard of care testing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BioFire

A molecular rapid syndromic testing platform, using the following panels:

• BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)
• BioFire FilmArray Pneumonia Panel plus (PP)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Adults (≥18 years old) presenting to the Emergency Room with an acute illness (present for 14 days or less) with cough, and with at least 1 other lower respiratory tract symptom or clinical sign at physical examination:

• Sputum production,
• Breathlessness,
• Chest discomfort or chest pain,
• Wheeze,
• Crackles,
• Self-reported dystermia or documented fever;
• Documented hypoxemia (adjusting definition for chronic oxygen therapy users, method of measurement) and no alternative explanation (infection, such as sinusitis; other, such as asthma).

2. Managing medical team considers:

1. to treat patient with antibiotics and/or to hospitalize patient

AND

2. that the rapid syndromic diagnostic test result can be awaited up to a maximum of 4 hours before the decision to discharge the patient or to initiate antibiotic therapy.

Exclusion Criteria

1. Development of ARTI more than 48 hours after hospital admission (hospital acquired);

2. Patients with cystic fibrosis;

3. Less than 14 days since the last episode of respiratory tract infection;

4. Pregnancy (confirmed by pregnancy test) and breastfeeding;

5. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases or patients with short life expectancy;

6. Inability to obtain informed consent from a competent patient.

Based on standard of care microbiological diagnosis and thoracic imaging (when indicated):

7. Radiologically confirmed acute lobar pneumonia;

8. Known or suspected Pneumocystis jirovecii pneumonia or active tuberculosis;

9. Alternative noninfectious diagnosis that explains clinical symptoms (pulmonary embolism, alveolar hemorrhage, acute heart failure, lung cancer).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioMérieux

INDUSTRY

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Dr. Cristina Prat

Sponsor Central Principal Investigator: Dr. C. Prat, MD, PhD, Microbiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc Bonten, MD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

University Hospital Gent

Ghent, , Belgium

University Hospital Pecs

Pécs, , Hungary

Clinical Center of Serbia

Belgrade, , Serbia

General Hospital Kragujevac

Kragujevac, , Serbia

Countries

Belgium; Hungary; Serbia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

WP4b - adults

Identifier Type: -

Identifier Source: org_study_id