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

Infection, Bacterial Clinical Trial

— TAPSI  

Official title:

Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985605
• Other study ID #: LMU 18-578
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: May 2022
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• routines TDM of antiinfectives

Exclusion Criteria:

• TDM is not available

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology of the University Hospital of Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of subtherapeutic antiinfective concentrations	Number of subtherapeutic concentrations from different antiinfectives in critically ill patients	four years
Primary	Correlation of meropenem concentration in serum to the concentration in brain fluid	The concentration of meropenem in the brain fluid of 30 patients with an external ventricular drainage will be correlated to their serum concentration	during the treatment with an external ventricular drainage
Primary	Subtherapeutic antiinfective concentrations during hemoadsorption	Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment	during hemoadsorption treatment
Secondary	28-day mortality of patients with therapeutic drug monitoring of antiinfectives	Correlation of antiinfective concentrations in serum to 28-day mortality	during intensive care treatment
Secondary	ICU-free days of patients with therapeutic drug monitoring of antiinfectives	Correlation of antiinfective concentrations in serum to ICU-free days to day 28	during intensive care treatment
Secondary	Sofa-score course of patients with therapeutic drug monitoring of antiinfectives	Correlation of antiinfective concentrations in serum to sofa-score	during the treatment with the antiinfectives
Secondary	Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives	Correlation of antiinfective concentrations to Interleukin-6 in critically ill patients	during the treatment with the antiinfectives
Secondary	Time course of CRP in patients with therapeutic drug monitoring of antiinfectives	Correlation of antiinfective concentrations to CRP in critically ill patients	during the treatment with the antiinfectives