Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms
Conditions
Interventions
None listed
Sponsors
Centre for Toxicovigilance and Drug Safety
Eligibility
Inclusion criteria
Inclusion criteria: Any gram-negative sepsis patients with renal impairment on therapy with Polymyxin B or Colistin
Exclusion criteria
Exclusion criteria: Blood samples of the included patients will be analyzed for polymyxin B and colistin concentration, and a pharmacokinetic model will be developed. One to one discussion with critical care physicians will be carried out. Later the results of the developed model and one to one discussion will be explained in a focus group discussion and a uniform dosing strategy will be created. The effectiveness and safety of this strategy will be compared with the existing traditional dosing strategy through an observational study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of a population pharmacokinetic model for Polymyxin B & Colistin in renally impaired patients with sepsisTimepoint: At baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the effectiveness & safety of developed polymyxins dosing strategy with the existing traditional dosing strategyTimepoint: At baseline | — |
Countries
India
Contacts
Public ContactGirish Thunga
Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal
Outcome results
None listed