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NCT Number: NCT03985605

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

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.

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Key information

Conditions

Infection, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology of the University Hospital of Munich

Munich, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • routines TDM of antiinfectives

Exclusion criteria

  • TDM is not available

Treatment and study plan

Primary outcomes

  1. Incidence of subtherapeutic antiinfective concentrations

    Time frame: four years

    Number of subtherapeutic concentrations from different antiinfectives in critically ill patients

  2. Correlation of meropenem concentration in serum to the concentration in brain fluid

    Time frame: 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

  3. Subtherapeutic antiinfective concentrations during hemoadsorption

    Time frame: during hemoadsorption treatment

    Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment

Secondary outcomes

  1. 28-day mortality of patients with therapeutic drug monitoring of antiinfectives

    Time frame: during intensive care treatment

    Correlation of antiinfective concentrations in serum to 28-day mortality

  2. ICU-free days of patients with therapeutic drug monitoring of antiinfectives

    Time frame: during intensive care treatment

    Correlation of antiinfective concentrations in serum to ICU-free days to day 28

  3. Sofa-score course of patients with therapeutic drug monitoring of antiinfectives

    Time frame: during the treatment with the antiinfectives

    Correlation of antiinfective concentrations in serum to sofa-score

  4. Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives

    Time frame: during the treatment with the antiinfectives

    Correlation of antiinfective concentrations to Interleukin-6 in critically ill patients

  5. Time course of CRP in patients with therapeutic drug monitoring of antiinfectives

    Time frame: during the treatment with the antiinfectives

    Correlation of antiinfective concentrations to CRP in critically ill patients

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness

Acronym: TAPSI

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2019
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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