None listed
Conditions
Brief summary
The primary purpose of the DALI-2 study is to describe the achievement of therapeutic antibiotic exposures (concentrations) in critically ill patients. Our HYPOTHESIS is that failing to achieve therapeutic antibiotic exposures (concentrations) in critically ill patients is an independent determinant of clinical outcomes, including clinical failure, mortality, ICU-free days, and the emergence of antimicrobial resistance, across diverse patient populations. Our VISION for DALI-2 is to pioneer a new era in the management of severe infections by providing definitive evidence that will reshape antibiotic dosing strategies for critically ill patients globally, irrespective of age. We aim to set a new benchmark for treatment efficacy and safety.
Interventions
The DALI-2 study does not have a study intervention. Treatment of infection will be conducted according to standard of care by the treating physician. This includes antibiotic dose, frequency, infusion time and duration of therapy and all microbiological cultures. The specific antibiotics includes are (beta-lactams: amoxicillin-clavulanate; amoxicillin; ampicillin; ampicillin/sulbactam; piperacillin-tazobactam; penicillin-G (benzylpenicillin); flucloxacillin; cloxacillin; cephazolin; cefiderocol
The DALI-2 study does not have a study intervention. Treatment of infection will be conducted according to standard of care by the treating physician. This includes antibiotic dose, frequency, infusion time and duration of therapy and all microbiological cultures. The specific antibiotics includes are (beta-lactams: amoxicillin-clavulanate; amoxicillin; ampicillin; ampicillin/sulbactam; piperacillin-tazobactam; penicillin-G (benzylpenicillin); flucloxacillin; cloxacillin; cephazolin; cefiderocol; cefotaxime; ceftazidime; ceftazidime/avibactam; cefoperazone/sulbactan; ceftolozane/tazobactam; ceftriaxone; cefepime; aztreonam; meropenem; imipenem/cilastatin; doripenem; ertapenem; meropenem/vaborbactam; imipenem/cilastin/relebactam; glycopeptides: Vancomycin; teicoplanin, other antibiotics: linezolid; daptomycin; tigecycline; colistin; amikacin; fosfomycin; gentamicin; tobramycin; ciprofloxacin; levofloxacin; trimethoprim/ sulfamethoxazole; metronidazole). Enrolled patients will have two to three blood samples collected over one dosing interval on the selected day of sampling, which is between 24 and 96 hours after starting the study antibiotic. For beta-lactam antibiotics, teicoplanin, and linezolid, two blood samples will be taken, with sample 1 taken mid-way through the dosing interval, and sample 2 taken within 30 minutes of the next dose. For vancomycin, daptomycin, tigecycline, fosfomycin, gentamicin, tobramycin, amikacin, ciprofloxacin, trimethoprim/sulfamethoxazole, and metronidazole, three blood samples will be required to determine the area under of the curve. Sample 1 will be taken 30 minutes after starting the infusion, sample 2 taken mid-way through the dosing interval, and sample 3 taken within 30 minutes of the next dose. All blood samples will be taken between 24 and 96 hours of antibiotic therapy, At Day 14 after initiation of the study antibiotic, vital status (alive or deceased), and if deceased, was the patient’s death related to infection will be recorded. Emergence of antibiotic resistance is recorded when subsequent cultures collected within 14 days of commencing the study antibiotic identify a resistant organism to the study antibiotic. At Day 30 after initiation of the study antibiotic, vital status (alive or deceased), and if deceased, was the patient’s death related to infection will be recorded. ICU free days at day 30 after initiation of the study antibiotic will be recorded, with deceased patients assigned a penalized value of zero days. Data collection is still required if the patient is transferred from the ICU to the ward or discharged.
Sponsors
University of Queensland
Eligibility
Sex/Gender
All
Age
1 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Patients are eligible for inclusion in the DALI-2 study if all the following inclusion criteria are met: 1. Patient is admitted to an ICU. 2. Patient receiving one of the specified intravenous antibiotics (including beta-lactams, glycopeptides, aminoglycosides and others) for the treatment of infection (i). 3. Suitable intravenous/intra-arterial access to facilitate sample collection. Capillary samples can be used in children if required. (arterial line preferred for sample collection). 4. Corrected gestational age of patient of 1 month or greater. 5. The patient must have been administered the study antibiotic for at least 24 hours. (i). Treatment is defined as either: empiric therapy (a clinical syndrome that may be due to infection is being treated) e.g. empiric antibiotics for aspiration pneumonitis/pneumonia, or directed therapy (treating an infection where a causative organism is identified). Please note that post-operative prophylactic antibiotics are not included.
Exclusion criteria
1. Patient’s death is deemed imminent and inevitable. 2. Patients who have received the study antibiotic for a duration exceeding 96 hours without accompanying blood sample collection.
Outcome results
None listed