Sepsis and septic shock
Conditions
Interventions
Product Name: Amoksiklav
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
Sponsors
University of Tartu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study inclusion criteria: 1) Age 18 years 2) Sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)1: 1. Sepsis - life-threatening organ dysfunction caused by a dysregulated host response to infection; that is suspected or documented infection and an acute increase of =2 SOFA points (a proxy for organ dysfunction) 2. Septic shock - sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) =65mmHg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation. 3) Antibacterial treatment with amoxicillin/clavulanic acid in the dose of 1.2g every 8 hours prescribed by the treating physician 4) Informed consent given by the patient or next of kin Arterial catheter in place on clinical indication 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: Study exclusion criteria: 1) Necessity of renal replacemen??t therapy 2) History of allergic reaction to amoxicillin or other penicillins 3) Absence of an arterial catheter Absence of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the PK of amoxicillin and clavulanic acid in the plasma and in in the subcutaneous tissue of adult patients with sepsis and septic shock.;Secondary Objective: To describe the effect of tissue perfusion on the tissue concentrations of amoxicillin and clavulanic acid in adult patients with sepsis and septic shock. To assess the adequacy of current dosing regimens, relating the measured plasma and tissue concentrations to minimal inhibitory concentrations of susceptible and intermediately susceptible causative pathogens. To assess the safety profile of amoxicillin and clavulanic acid in adult patients with sepsis and septic shock.;Primary end point(s): Pharmakokinetic parameters of IMPs (T1/2; Cmax, Cmin, AUC0-8, T above MIC; serum and tissue concentrations);Timepoint(s) of evaluation of this end point: Blood samples for amoxicillin and clavulanic acid plasma concentration measurements will be drawn before and immediately after the end amoxicillin/clavulanic acid infusion and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7 and 8 hours after the start of the 2nd and 5th dose administration. Microdialysis. Two baseline samples will be taken before the second and fifth planned amoxicillin/clavulanic acid dose. Microdialysis samples will be collected as follows: approximately 20, 40 min, 1, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 and 8 h after the start of the 2nd and 5th dose administration. Urine samples will be taken 2 hours, 4 hours and 8 hours after administration of the 2nd and 5th dose of amoxicillin/clavulanic acid. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adequacy of plasma and tissue concentrations in relation to MIC of causative pathogens;Timepoint(s) of evaluation of this end point: 48 hours after the administration of the first dose of the IMP | — |
Countries
Estonia
Contacts
Public ContactClinical Trials Information
Tartu University
Outcome results
None listed