- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04547556
ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms (ADEQUATE)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lübeck, Germany, 23538
- University Hospital Schleswig-Holstein
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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:
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.
Exclusion Criteria:
- 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).
Study Plan
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 |
---|---|
Experimental: Intervention
|
A molecular rapid syndromic testing platform, using the following panels:
|
No Intervention: Standard of Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days alive out of hospital (superiority endpoint)
Time Frame: Day 1 - Day 14
|
Day 1 - Day 14
|
|
Days on Therapy (DOT) with antibiotics (superiority endpoint)
Time Frame: Day 1 - Day 14
|
Day 1 - Day 14
|
|
Adverse outcome (non-inferiority safety endpoint)
Time Frame: Day 1 - Day 30
|
|
Day 1 - Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Direct costs and indirect costs within 30 days after enrolment.
Time Frame: Day 1 - Day 30
|
|
Day 1 - Day 30
|
Quality of life as determined by EQ5D-5L (or suitable alternative for age), days away from work if applicable, and healthcare utilisation on day 1, 14, and 30 after enrolment.
Time Frame: Day 1, 14, 30
|
Quality of life as determined by EQ5D-5L (or suitable alternative for age), days away from work if applicable, and healthcare utilisation on day 1, 14, and 30 after enrolment.
|
Day 1, 14, 30
|
Microbiological results obtained as standard of care and with the diagnostic intervention
Time Frame: Day 1
|
Proportion of participants with an identified respiratory pathogen in both study groups on randomisation day samples.
|
Day 1
|
Empirical antibiotics based on antimicrobial agent categories
Time Frame: Day 1 - Day 14
|
Proportion of participants on non-first-line anti-infective regimens (as defined by local guidelines)
|
Day 1 - Day 14
|
Antibiotic type switches and de-escalation based on antimicrobial agent categories
Time Frame: Day 1 - Day 14
|
Time to de-escalation and time to stop of anti-infective therapy
|
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.
Time Frame: >7 days after randomisation
|
Proportion of hospitalised participants with detection of cephalosporin-, carbapenem- or chinolone-resistant Enterobacteriaceae on any standard of care samples >7 days after randomisation
|
>7 days after randomisation
|
Impact on decisions regarding isolation measures related to test result.
Time Frame: Day 1 - Day 30
|
Hours in individual or cohort isolation in hospitalised participants
|
Day 1 - Day 30
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WP4b - adults
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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