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Clinical and Economic Impact of Interventions by a Clinical Pharmacist on Antibiotic Use on Surgical Wards

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00431483
Recruitment Status : Completed
First Posted : February 5, 2007
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
Alexandra Weber, Ludwig-Maximilians - University of Munich

Brief Summary:
The purpose of this study is to establish the impact of a pharmacist's recommendations regarding choice, dosing and duration of antibiotic therapy on quality and cost of antibiotic treatment on surgical wards.

Condition or disease Intervention/treatment
Bacterial Infections Behavioral: pharmaceutical consulting

Detailed Description:

Inappropriate or incorrect use of antibacterials exerts selection pressure on pathogens potentiating emergence of resistance, puts patients at risk for unnecessary adverse drug reactions and potentially prolongs the length of stay in hospital thus increasing healthcare costs.

In an effort to improve the quality of antibiotic drug therapy on surgical wards of a large university hospital, specific consulting by a clinical pharmacist was established.

The objective of this study is to assess the impact of pharmaceutical consulting on the quality and costs of antibiotic use in surgical wards.

Comparison:

Within a control period the current pattern of antibiotic use is monitored. During the intervention period, the impact of the interventions made by the clinical pharmacist on antibiotic use is examined. One ward serves as a parallel control group; no intervention is being made on this ward throughout this study.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 779 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Clinical and Economic Impact of Interventions by a Clinical Pharmacist on Antibiotic Use on Surgical Wards
Study Start Date : February 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
Pharmaceutical counseling Behavioral: pharmaceutical consulting
to measure if information and advice by a pharmacist has an impact on quality and quantity of prescribed antibacterials



Primary Outcome Measures :
  1. overall duration of antibiotic therapy during study period [ Time Frame: Feb 2008 ]

Secondary Outcome Measures :
  1. iv to oral switch [ Time Frame: Feb 2008 ]
    number of courses of iv antibiotics switched to oral antibiotics; duration of iv treatment

  2. compliance of treatment with hospital formulary for antibiotic therapy [ Time Frame: Feb 2008 ]
  3. cost of antibiotic therapy [ Time Frame: Feb 2008 ]
  4. number and duration of therapy with antibiotics with redundant spectra [ Time Frame: Feb 2008 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female and male patients receiving antibiotics for a proven or suspected infection on designated surgical wards

Exclusion Criteria:

  • patients under 18
  • patients unable or unwilling to consent to their data being evaluated
  • patients receiving antibiotics perioperatively as prophylaxis
  • patients receiving antibiotics for less than 48hrs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431483


Locations
Germany
Luwig Maximilians University - Klinikum Grosshadern
Munich, Bavaria, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Study Director: Karl-Walter Jauch, Prof. Dr. Klinikum Grosshadern

Responsible Party: Alexandra Weber, Pharmacist, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00431483     History of Changes
Other Study ID Numbers: AW2007
First Posted: February 5, 2007    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013

Keywords provided by Alexandra Weber, Ludwig-Maximilians - University of Munich:
antibacterial agents
surgery
pharmacist
economics, pharmaceutical

Additional relevant MeSH terms:
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents