Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness = TAPSI

Completed

• Conditions: Infection, Bacterial

• Registration Number: NCT03985605
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

Therapeutic drug monitoring of antiinfectives in intensive care patients is an usual research topic of the last years. Based on research result, which have shown subtherapeutic plasma concentrations of antibiotics, a routines therapeutic drug monitoring for β-lactam-antibiotics was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany. This study is an prospective evaluation of these TDM-program.

Detailed Description

Bacterial infections are associated with high mortality in intensive care patients. Antibiotic therapy is the only causal opportunity to treat those infections. Pharmacokinetic and -dynamic changes in critically ill patients lead to unpredictable plasma concentrations of the applied drugs. Research results of the last years with many quantified plasma concentrations in subtherapeutic levels yield to the recommendation of the Paul-Ehrlich-Society for an routines therapeutic drug monitoring of antibiotics in intensive care patients. These was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany for all intensive care patients as a routines procedure. The introduced study is a prospective evaluation of the TDM-program with regard to improvement opportunity, influencing factors and parallels to other studies.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-14
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• routines TDM of antiinfectives

Exclusion Criteria

• TDM is not available

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of meropenem concentration in serum to the concentration in brain fluid	during the treatment with an external ventricular drainage	The concentration of meropenem in the brain fluid of 30 patients with an external ventricular drainage will be correlated to their serum concentration
Incidence of subtherapeutic antiinfective concentrations	four years	Number of subtherapeutic concentrations from different antiinfectives in critically ill patients
Subtherapeutic antiinfective concentrations during hemoadsorption	during hemoadsorption treatment	Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment

Secondary Outcome Measures

Name	Time	Method
28-day mortality of patients with therapeutic drug monitoring of antiinfectives	during intensive care treatment	Correlation of antiinfective concentrations in serum to 28-day mortality
ICU-free days of patients with therapeutic drug monitoring of antiinfectives	during intensive care treatment	Correlation of antiinfective concentrations in serum to ICU-free days to day 28
Sofa-score course of patients with therapeutic drug monitoring of antiinfectives	during the treatment with the antiinfectives	Correlation of antiinfective concentrations in serum to sofa-score
Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives	during the treatment with the antiinfectives	Correlation of antiinfective concentrations to Interleukin-6 in critically ill patients
Time course of CRP in patients with therapeutic drug monitoring of antiinfectives	during the treatment with the antiinfectives	Correlation of antiinfective concentrations to CRP in critically ill patients

Trial Locations

Locations (1)

Department of Anaesthesiology of the University Hospital of Munich; 🇩🇪 Munich, Germany