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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness

Conditions
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Infection, Bacterial

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: routines TDM of antiinfectives Exclusion Criteria: TDM is not available

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of subtherapeutic antiinfective concentrations | Number of subtherapeutic concentrations from different antiinfectives in critically ill patients | four years | 
| 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 | 
| Subtherapeutic antiinfective concentrations during hemoadsorption | Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment | during hemoadsorption treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TDM, Routine, intensive care patients