ADEQUATE Advanced Diagnostics for Enhanced Quality of Antibiotic Prescription

NCT04547556 | Terminated Results DMC FDA Device

• 1 other identifier: WP4b - adults
• Study Type: interventional
• Target: 185
• Locations: 3 countries
• Sites: 4

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.

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (3)

• Days Alive Out of Hospital (Superiority Endpoint)

  Days alive out of hospital (superiority endpoint), within 14 days after study enrolment

  Day 1 - Day 14

• Days on Therapy (DOT) With Antibiotics (Superiority Endpoint)

  Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment

  Day 1 - Day 14

• Adverse Outcome (Non-inferiority Safety Endpoint)

  * For initially non-admitted patients: any admission or death * For initially hospitalized patients: any readmission, ICU admission \>= 24 hours after hospitalization, or death

  Day 1 - Day 30

Secondary Outcomes (6)

• Direct Costs and Indirect Costs Within 30 Days After Enrolment.

  Day 1 - Day 30

• Microbiological Results Obtained as Standard of Care and With the Diagnostic Intervention

  Day 1

• Empirical Antibiotics Based on Antimicrobial Agent Categories

  Day 1 - Day 14

• Antibiotic Type Switches and De-escalation Based on Antimicrobial Agent Categories

  Day 1 - Day 14

• Detection of Antimicrobial Resistance (Carriage or Infection) Related to the Diagnostic Intervention Results Compared to Standard of Care and Impact on Antimicrobial Stewardship Guidelines and Prevention of Hospital Acquired Infections.

  >7 days after randomisation

Study Arms (2)

Intervention

EXPERIMENTAL

Diagnostic intervention

Diagnostic Test: BioFire

Standard of Care

NO INTERVENTION

Standard of care testing

Interventions

BioFire 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)

Intervention

Eligibility Criteria

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

You may qualify if:

• 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).
• \. Managing medical team considers:
• to treat patient with antibiotics and/or to hospitalize patient
• AND
• 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.

You may not qualify if:

• Development of ARTI more than 48 hours after hospital admission (hospital acquired);
• Patients with cystic fibrosis;
• Less than 14 days since the last episode of respiratory tract infection;
• Pregnancy (confirmed by pregnancy test) and breastfeeding;
• 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;
• Inability to obtain informed consent from a competent patient.
• Based on standard of care microbiological diagnosis and thoracic imaging (when indicated):
• Radiologically confirmed acute lobar pneumonia;
• Known or suspected Pneumocystis jirovecii pneumonia or active tuberculosis;
• Alternative noninfectious diagnosis that explains clinical symptoms (pulmonary embolism, alveolar hemorrhage, acute heart failure, lung cancer).

Sponsors & Collaborators

• UMC Utrecht: lead
• BioMérieux: collaborator

Study Sites (4)

University Hospital Gent

Ghent, Belgium

Location

University Hospital Pecs

Pécs, Hungary

Location

Clinical Center of Serbia

Belgrade, Serbia

Location

General Hospital Kragujevac

Kragujevac, Serbia

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Limitations and Caveats

The calculated sample size for the trial NCT04547556, which is the adult arm of the ADEQUATE trial could not be achieved and study was terminated due to poor enrolment. Outcome measures that could be calculated are provided.

Results Point of Contact

• Title: Dr Cristina Prat Aymerich
• Organization: UMC Utrecht

c.prataymerich-2@umcutrecht.nl

+31631118128

Study Officials

• Marc Bonten, MD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor Central Principal Investigator: Dr. C. Prat, MD, PhD, Microbiologist

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: October 25, 2021
• Primary Completion: May 21, 2022
• Study Completion: May 21, 2022
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Locations

SE (2); BE (1); HU (1)