- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00431483
Clinical and Economic Impact of Interventions by a Clinical Pharmacist on Antibiotic Use on Surgical Wards
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bavaria
-
Munich, Bavaria, Germany, 81377
- Luwig Maximilians University - Klinikum Grosshadern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Pharmaceutical counseling
|
to measure if information and advice by a pharmacist has an impact on quality and quantity of prescribed antibacterials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall duration of antibiotic therapy during study period
Time Frame: Feb 2008
|
Feb 2008
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
iv to oral switch
Time Frame: Feb 2008
|
number of courses of iv antibiotics switched to oral antibiotics; duration of iv treatment
|
Feb 2008
|
compliance of treatment with hospital formulary for antibiotic therapy
Time Frame: Feb 2008
|
Feb 2008
|
|
cost of antibiotic therapy
Time Frame: Feb 2008
|
Feb 2008
|
|
number and duration of therapy with antibiotics with redundant spectra
Time Frame: Feb 2008
|
Feb 2008
|
Collaborators and Investigators
Investigators
- Study Director: Karl-Walter Jauch, Prof. Dr., Klinikum Großhadern
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AW2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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