NCT03985605

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

Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection, Bacterial

Timeline

• Start date: 2018-01-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2019-06-14
• Last updated: 2022-06-01

Locations

1 site across 1 country: Germany