Trial document




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  DRKS00000025

Trial Description

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Title

Klacid – postmarketing observational study in patients with serious community-acquired pneumonia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The antibiotic Klacid® contains the agent clarithromycin. Klacid® is available for oral application as well as for intravenous application. Penetrating the body from the blood Klacid® disseminates well into the tissue and accumulates at the location of the infection. Because of this the pathogens can be reached easily. It shows a distinct efficacy to a broad spectrum of bacteria. Klacid® is mainly metabolized in the liver.
Due to its special spectrum of activity, the constant low rates of resistance and its good tolerability, Klacid® is very suitable for the therapy of disorders of the airways.
The aim of this postmarketing observational study is to obtain new knowledge about safety und tolerability of Klacid® in treating patients with serious community-acquired pneumonia.
In the context of a postmarketing observational study, the use of Klacid® can be documented in a high number of patients and under conditions simulating practical use. Rare adverse effects shall be traced or previously known good tolerability of the drug shall be confirmed. A further aim is to acquire additional data on efficacy, especially the rapid onset of action.

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Brief Summary in Scientific Language

The antibiotic Klacid® contains the agent clarithromycin and belongs to the class of macrolides. There is as well an intravenous as an oral route of administration. Penetrating the body from the blood Klacid® disseminates well into the tissue and accumulates at the location of the infection. By penetrating phagocytes it can reach intracellular pathogens. The antibacterial effect is due to a selective binding to the 50-S-subunit of bacterial ribosomes, which leads to an inhibition of cellular protein-synthesis. At accordingly high levels the agent Klacid® has a bactericidal effect. It has a distinct efficacy against a broad range of aerobic and anaerobic, gram-positive, gram-negative and acid-fast bacteria. Klacid® is mainly eliminated by the liver. Due to its special spectrum of activity, the constant low rates of resistance and its good tolerability, Klacid® is very suitable for the therapy of disorders of the airways.
The aim of this postmarketing observational study is to obtain new knowledge about safety und tolerability of Klacid® in treating patients with serious community-acquired pneumonia (CAP).
In the context of a postmarketing observational study, the use of Klacid® can be documented in a high number of patients and under conditions simulating practical use. Rare adverse effects shall be traced or previously known good tolerability of the drug shall be confirmed. A further aim is to acquire additional data on efficacy, especially the rapid onset of action.

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Organizational Data

  •   DRKS00000025
  •   2008/09/05
  •   2005/05/21
  •   yes
  •   Approved
  •   274/02, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   UKF000562  (UKFReg)
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Health Condition or Problem studied

  •   serious community-acquired pneumonia
  •   J18 -  Pneumonia, organism unspecified
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Interventions/Observational Groups

  •   Klacid® therapy
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

The use of Klacid® will be documented in a high number of patients under conditions simulating practical use. Rare adverse effects shall be traced or previously known good tolerability of the drug shall be confirmed. An additional goal is to collect further data on efficacy and also the rapid onset of action.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2003/01/07
  •   70
  •   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

- One of these three signs: fever, purulent sputum, typical auscultation findings
- An infiltration in X-ray
- Start of anti-infective therapy with Klacid within 24 hours after admission
- The diagnosis is: community acquired

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Exclusion Criteria

- Pretreatment with Klacid
- Transfer from another hospital

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Addresses

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    • ABBOTT GmbH & Co. KG
    • Max-Planck Ring 2
    • 65205  Wiesbaden
    • Germany
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    •   +49 (0)6122-58 0
    •   [---]*
    •   [---]*
    •   [---]*
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    • Institut für Umweltmedizin und Krankenshaushygiene Universitätsklinik Freiburg
    • Mr.  Prof. Dr.  Franz  Daschner 
    • Breisacher Straße 115
    • 79110  Freiburg
    • Germany
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    • Institut für Umweltmedizin und Krankenshaushygiene Universitätsklinik Freiburg
    • Mr.  Prof. Dr.  Franz  Daschner 
    • Breisacher Straße 115
    • 79110  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • ABBOTT GmbH & Co. KG
    • Max-Planck-Ring 2
    • 65205  Wiesbaden
    • Germany
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    •   +49 (0)6122-58 0
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2005/09/14
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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.