None listed
Conditions
Brief summary
Severe Gram-positive bacterial infections, particularly those caused by MRSA, pose a significant challenge in the Intensive Care Unit and are associated with high mortality and complications such as acute kidney injury when treated with standard vancomycin therapy. This study aims to compare the clinical efficacy and safety of targeted therapy with ceftaroline fosamil versus vancomycin in this critically ill population. This is a prospective, open-label, randomized controlled trial conducted at the Intensive Care Unit of Viet Duc University Hospital. Eligible patients will be randomly assigned in a 1:1 ratio to receive either intravenous ceftaroline or standard-of-care vancomycin (optimized by therapeutic drug monitoring) for 7 to 14 days. The primary outcome evaluated will be the clinical success rate at the end of therapy, with secondary outcomes focusing on the incidence of acute kidney injury, 28-day mortality, and microbiological eradication. We hypothesize that ceftaroline will be as effective as vancomycin in treating these severe infections, while causing fewer kidney-related side effects.
Interventions
Patients randomized to the intervention group will receive Ceftaroline fosamil (Zinforo) via intravenous (IV) infusion. The standard dosage is 600 mg administered every 12 hours (infused over 60 minutes). Dosage will be adjusted according to the patient's renal function (creatinine clearance) following the manufacturer's guidelines. The expected duration of treatment is 7 to 14 days, depending on the clinical response and the specific type of infection. Adherence to the intervention will be stri
Patients randomized to the intervention group will receive Ceftaroline fosamil (Zinforo) via intravenous (IV) infusion. The standard dosage is 600 mg administered every 12 hours (infused over 60 minutes). Dosage will be adjusted according to the patient's renal function (creatinine clearance) following the manufacturer's guidelines. The expected duration of treatment is 7 to 14 days, depending on the clinical response and the specific type of infection. Adherence to the intervention will be strictly monitored and ensured by the intensive care unit (ICU) nursing staff, who are responsible for administering all intravenous infusions. The exact dose, time of administration, and any missed or interrupted doses will be directly documented in the patient's medical records and daily medication administration charts.
Sponsors
Hanoi Medical University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age >= 18 years. 2. Currently admitted to the Intensive Care Unit (ICU). 3. Clinical and/or radiological evidence of a severe infection (e.g., hospital-acquired/ventilator-associated pneumonia, bloodstream infection, complicated skin and soft tissue infection, or central nervous system infection). 4. Microbiological culture positive for a Gram-positive pathogen (e.g., Staphylococcus aureus, Coagulase-negative staphylococci, Enterococcus spp.). 5. Antimicrobial susceptibility testing (AST) confirms the isolated pathogen is susceptible (S) to BOTH Ceftaroline and Vancomycin. 6. Written informed consent obtained from the patient or their legally authorized representative.
Exclusion criteria
1. Documented allergy or hypersensitivity to beta-lactam antibiotics, cephalosporins, or glycopeptides (Vancomycin). 2. End-stage renal disease (ESRD) requiring routine hemodialysis or continuous renal replacement therapy (CRRT) prior to the onset of the current infection (to avoid confounding the evaluation of acute kidney injury). 3. Moribund clinical status with an expected survival of $\le$ 48 hours from the time of ICU admission, regardless of the antimicrobial therapy administered. 4. Concurrent use of targeted systemic Gram-positive active antibiotics for more than 72 hours immediately prior to randomization (empirical therapy within the first 72 hours while waiting for culture results is permitted). 5. Pregnant or breastfeeding women.
Outcome results
None listed