Amoxicillin/clavulanic acid in sepsis and septic shock

Phase 1

• Conditions: Sepsis and septic shock; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-002195-27-EE
• Lead Sponsor: niversity of Tartu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified