Randomized-controlled Trial (RCT) on Combination Antibiotic for Infections Caused by Gram-negative Bacteria (XDR-GNB)
Bacteremia, Healthcare-associated Pneumonia, Ventilator-associated Pneumonia
About this trial
This is an interventional treatment trial for Bacteremia focused on measuring Multicenter, Open-label, Randomized, Controlled, RCT, antibiotic, drug-resistant, Gram-negative, bacteria
Eligibility Criteria
Inclusion Criteria:
- Monomicrobial XDR-GNB bacteremia.
- Monomicrobial XDR-GNB ventilator-associated pneumonia OR healthcare-associated pneumonia.
Exclusion Criteria (will be excluded if subjects meet one or more of the following criteria):
- Allergy to any of the study medications.
- For female patients, the patients is pregnant.
- Unable to provide consent and have no legally authorized representatives.
- Currently enrolled in another trial.
- >48 hours after XDR-GNB confirmation by the microbiology laboratory.
- Palliative care or with less than 24 hours of life expectancy, as discussed with their primary physicians.
- Co-infection with other aerobic Gram-negative bacteria.
Severe renal impairment (creatinine clearance <30 milliliters (mL)/min).
- Concurrent infection not involving the lungs or bloodstream is not an exclusion criterion for the study.
Sites / Locations
- National University Hospital
- Singapore General Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Polymyxin B
Polymyxin B + Doripenem
Intravenous polymyxin B will be started on a standard dose of 25,000 Units (U)/kg body weight, in 2 divided doses each day, infused over 2 hours. The duration of intravenous antibiotic treatment for subjects with either bacteremia or VAP or HAP will be at least 10 days. The duration of intravenous polymyxin B can be prolonged based on clinical indication, e.g., deep-seated source of infection, etc. For patients with VAP, nebulized colistin at the dose of 2 million units (MU) 8 hourly for 5 days will be prescribed.
Standard dose of intravenous polymyxin B at 25,000U/kg body weight will be given in 2 divided doses each day with each dose infused over 2 hours and intravenous doripenem 500mg, with each dose infused over 4 hours. For patients with VAP, nebulized colistin at the dose of 2 MU 8 hourly for 5 days will be prescribed.