Trial document





This trial has been registered retrospectively.
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  DRKS00004392

Trial Description

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Title

Determination of drugs and their metabolites in hospitalized patients.

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Trial Acronym

PEAK-001

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The current state of knowledge on the concentration of drugs and their metabolites in the individual human body is not satisfying concerning the question about behavior of drugs in the human body, taking into account individual patient factors such as age, weight and organ function.

This projects deals with the question of drug levels (cancer drugs and drugs for the treatment of infections) in the blood of hospitalized patients.

The aim of our study is to extend the knowledge about the behavior of drugs in the human body significantly, for the safety and benefit of future patients. This also includes to establish a relationship between drug levels in patients and the desired and undesired effects of a drug.

As a result, the future perspective is to find the optimal dose for the individual patient by measuring the blood concentration of a drug.

Blood concentrations of drugs in residual blood of routine blood draws in up to 100 patients will be determined to attain this objective.

Since the influence of individual patient factors is the focus of this study, all hospitalized patients receiving anticancer drugs or antiinfectives are eligible for this study, regardless their individual conditions.

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Brief Summary in Scientific Language

The main objective of the study is to gain an overview of the plasma concentrations of antineoplastic and antiinfective drugs which occur in different patient populations and to what extent they are consistent with those concentrations described in the literature.

If the expectation is confirmed, that a significant heterogeneity in the plasma concentrations of these patients exists, we will try to find influencing factors for this circumstance on the basis of routine clinical parameters (height, weight, renal function, concomitant medications, etc.).

Ultimately, this project will identify substances with a high interindividual variability in plasma levels, where drug monitoring might be suggested.

Blood concentrations of drugs in residual blood of routine blood draws in up to 100 hospitalized patients receiving antineoplastic or antiinfective agents will be determined to attain this objective.

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Organizational Data

  •   DRKS00004392
  •   2012/10/15
  •   [---]*
  •   yes
  •   Approved
  •   107_12 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  •   U1111-1135-2755 
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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
  •   Infections
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Interventions/Observational Groups

  •   Determination of plasma concentrations [ng/mL] of antineoplastic agents and antiinfectives in hospitalized patients receiving antineoplastic or antiinfective agents at time points when minimum and maximum plasma levels are expected.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   No
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Primary Outcome

Plasma concentrations [ng/mL] of antineoplastic agents and antiinfectives in hospitalized patients receiving antineoplastic or antiinfective agents at time points when minimum and maximum plasma levels are expected.
The plasma concentrations will be determined by liquid chromatography - tandem mass spectrometry or by immunological methods.

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Secondary Outcome

Variability of plasma concentrations [ng/mL] of antineoplastic agents and antiinfectives as a function of individual patient factors as height, weight, liver function and renal function.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/08/27
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

legal capacity, treatment with antineoplastic or antiinfective drugs

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Exclusion Criteria

severe anemia

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Addresses

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    • Medizinische Klinik 5 - Hämatologie/Onkologie Klinikum Nürnberg
    • Mr.  Prof. Dr.  Martin  Wilhelm 
    • Prof.-Ernst-Nathan-Str. 1
    • 90419  Nürnberg
    • Germany
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    • Medizinische Klinik 5 - Hämatologie/Onkologie Klinikum Nürnberg
    • Mr.  Prof. Dr.  Martin  Wilhelm 
    • Prof.-Ernst-Nathan-Str. 1
    • 90419  Nürnberg
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Medizinische Klinik 5 - Hämatologie/Onkologie Klinikum Nürnberg
    • Mr.  Prof. Dr.  Martin  Wilhelm 
    • Prof.-Ernst-Nathan-Str. 1
    • 90419  Nürnberg
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Klinik 5 - Hämatologie/Onkologie Klinikum Nürnberg
    • Mr.  Prof. Dr.  Martin  Wilhelm 
    • Prof.-Ernst-Nathan-Str. 1
    • 90419  Nürnberg
    • Germany
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    • Verein “Hilfe für Krebskranke e.V.” Nürnberg
    • Mr.  Prof. Dr.  Martin  Wilhelm 
    • Prof.-Ernst-Nathan-Str. 1
    • 90419  Nürnberg
    • Germany
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    • IBMP - Institute for Biomedical and Pharmaceutical Research
    • Mr.  Prof. Dr.  Fritz  Sörgel 
    • Paul-Ehrlich-Str. 19
    • 90562  Heroldsberg
    • Germany
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    •   0049911518280
    •   [---]*
    •   ibmp at osn.de
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.