Community-acquired Acute Lower Respiratory Infection Clinical Trial
— ADEQUATEOfficial title:
ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms - Paediatric
| NCT number | NCT04781530 |
| Other study ID # | ADEQUATE |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 7, 2021 |
| Est. completion date | January 25, 2024 |
| Verified date | June 2024 |
| Source | PENTA Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is a randomized controlled trial where participants are randomly assigned in a 1:1 ratio to either a rapid test group or a control group. Standard care is provided in the control group. Follow-up is conducted until discharge from the hospital, followed by telephone check-ins and completion of questionnaires by the participants themselves or their proxies until 30 days after randomization. Children of any age presenting at selected participating sites with acute respiratory tract infections, where initial treatment decisions are uncertain, are eligible to participate. The study aims to enrol 520 participants and involves Paediatric Emergency Rooms across Europe.
| Status | Completed |
| Enrollment | 522 |
| Est. completion date | January 25, 2024 |
| Est. primary completion date | January 25, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 17 Years |
| Eligibility | Inclusion Criteria: 1. Children of any age presenting to the Emergency Room with an acute illness (present for 14 days or less) with Temperature =38.0°C measured at presentation or reported within the previous 24 hours AND at least two of the below: - Cough - Abnormal sounds on chest auscultation (crackles, reduced breath sounds, bronchial breathing, wheezing) - Clinical signs of dyspnea (chest indrawing, nasal flaring, grunting) - Signs of respiratory dysfunction: tachypnoea for age or decreased oxygen saturation (<92% in room air) - Signs of reduced general state: poor feeding, vomiting or lethargy/drowsiness 2. At time of screening: - Patient has undergone first assessment by managing clinical team (doctor or nurse, incl. triage) - Hospitalisation is not yet determined, i.e. neither by clinical presentation definitely requiring hospitalisation (e.g. per local guideline) nor by fixed decision of managing clinical team; admission to a short-stay unit or surveillance unit is not considered a hospitalisation for this trial - Antibiotic treatment or hospitalisation is being considered - The rapid syndromic diagnostic test result can be awaited for up to 4 hours before the decision to discharge the patient or to initiate antibiotic treatment is made Exclusion Criteria: 1. Development of ARTI more than 48 hours after hospital admission (hospital acquired); 2. Patients with a severe underlying medical condition dictating management decisions including hospitalisation and/or antibiotic treatment (e.g cystic fibrosis, immunosuppression); 3. Less than 14 days since the last episode of respiratory tract infection; 4. Confirmed pregnancy and/or 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; 7. Alternative noninfectious diagnosis that explains clinical symptoms. |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Children's Hospital Basel (UKBB) | Basel | Basel-Stadt |
| Lead Sponsor | Collaborator |
|---|---|
| PENTA Foundation | BioMérieux, St George's, University of London, Universiteit Antwerpen |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Days alive out of hospital (superiority endpoint), within 14 days after study enrolment | Days alive out of hospital (superiority endpoint), within 14 days after study enrolment | 14 days | |
| Primary | Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment | Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment | 14 days | |
| Primary | Adverse outcome (non-inferiority safety endpoint) | 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, all within 30 days |
30 days | |
| Secondary | Direct costs and indirect costs within 30 days after enrolment. | Cost of healthcare within 30 days after enrolment, including hospital and ICU days, utilisation of non-hospital services and cost of anti-infective and concomitant medication
Cost of workdays lost within 30 days, including days for childcare |
30 days | |
| Secondary | Quality of life as determined by EQ5D-5L (or suitable alternative for age), days away from usual childcare routine or school and healthcare utilisation on day 1, 14, and 30 after enrolment. | Quality of life as determined by EQ5D-5L (or suitable alternative for age), days away from usual childcare routine or school and healthcare utilisation on day 1, 14, and 30 after enrolment. | 1, 14 and 30 days | |
| Secondary | Microbiological results obtained as standard of care and with the diagnostic intervention | Proportion of participants with an identified respiratory pathogen in both study groups on randomisation day samples. | Day 1 | |
| Secondary | Empirical antibiotics based on antimicrobial agent categories | Proportion of participants on non-first-line anti-infective regimens (as defined by local guidelines) | Day 1 - Day 14 | |
| Secondary | Antibiotic type switches and de-escalation based on antimicrobial agent categories | Time to de-escalation and time to stop of anti-infective therapy | Day 1 - Day 14 | |
| Secondary | 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 | 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 | |
| Secondary | Impact on decisions regarding isolation measures related to test result. | Hours in individual or cohort isolation in hospitalised participants | Day 1 - Day 30 |