Bloodstream infection (bacteremia) or hospital-acquired pneumonia by Gram-negative bacillus lacking susceptibility to all of the following antibiotics: cefepime OR ceftazidime, imipenem OR meropenem, piperacillin/tazobactam, ciprofloxacin OR levofloxacin MedDRA version: 12.1 Level: LLT Classification code 10060562 Term: Bacteremia, unspecified MedDRA version: 12.1 Level: LLT Classification code 10064977 Term: Acinetobacter bacteremia MedDRA version: 12.1 Level: LLT Classification code 1005422
Conditions
Interventions
Trade Name: Colistin
Product Name: Colistin mesilate sodium
Pharmaceutical Form: Intravenous infusion
Sponsors
University of Athens, Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient of 18 years of age or older 2. Expectation of hospitalization of = 48 hours 3. Receipt of intravenous colistin for clinical care 4. Provision of written informed consent by the patient or by a relative legally able to give proxy consent if the patient cannot give consent 5. Infection is defined by Center for Disease Control and Prevention (CDC) definitions of bloodstream infection (bacteremia) or hospital-acquired pneumonia:85 6. Patient must have growth from blood culture or a respiratory specimen culture of a Gram-negative bacillus lacking susceptibility to all of the following antibiotics: cefepime OR ceftazidime, imipenem OR meropenem, piperacillin/tazobactam, ciprofloxacin OR levofloxacin 7. Adequate venous access to enable collection of blood for determination of CMS and generated colistin in plasma Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Currently pregnant or breastfeeding 2. Currently incarcerated 3. Concomitant use of colistin or polymyxin B delivered directly into the respiratory tract 4. Known allergy to colistin or polymyxin B 5. Cystic fibrosis 6. Estimated life expectancy of less than one week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the disposition of colistin in plasma in critically-ill patients;Secondary Objective: 1.To determine the clearance of colistin via renal replacement therapy 2. Toestablish the co-variates influencing the pharmacokinetics of colistin. 3. To establish the inter-relationships of the pharmacokinetics and pharmacodynamics of colistin with bacteriological and clinical outcomes 4. To investigate inter-relationships between the pharmacokinetics of colistin, duration of therapy and patient characteristics with development of bacterial resistance to colistin.;Primary end point(s): To characterize the disposition of colistin in plasma in critically-ill patients | — |
Countries
Greece
Outcome results
None listed