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

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
pharmaceutical consulting
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bacterial Infections focused on measuring antibacterial agents, surgery, pharmacist, economics, pharmaceutical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Luwig Maximilians University - Klinikum Grosshadern

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pharmaceutical counseling

Arm Description

Outcomes

Primary Outcome Measures

overall duration of antibiotic therapy during study period

Secondary Outcome Measures

iv to oral switch
number of courses of iv antibiotics switched to oral antibiotics; duration of iv treatment
compliance of treatment with hospital formulary for antibiotic therapy
cost of antibiotic therapy
number and duration of therapy with antibiotics with redundant spectra

Full Information

First Posted
February 1, 2007
Last Updated
September 25, 2013
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00431483
Brief Title
Clinical and Economic Impact of Interventions by a Clinical Pharmacist on Antibiotic Use on Surgical Wards
Official Title
Clinical and Economic Impact of Interventions by a Clinical Pharmacist on Antibiotic Use on Surgical Wards
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
antibacterial agents, surgery, pharmacist, economics, pharmaceutical

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
779 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmaceutical counseling
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
pharmaceutical consulting
Intervention Description
to measure if information and advice by a pharmacist has an impact on quality and quantity of prescribed antibacterials
Primary Outcome Measure Information:
Title
overall duration of antibiotic therapy during study period
Time Frame
Feb 2008
Secondary Outcome Measure Information:
Title
iv to oral switch
Description
number of courses of iv antibiotics switched to oral antibiotics; duration of iv treatment
Time Frame
Feb 2008
Title
compliance of treatment with hospital formulary for antibiotic therapy
Time Frame
Feb 2008
Title
cost of antibiotic therapy
Time Frame
Feb 2008
Title
number and duration of therapy with antibiotics with redundant spectra
Time Frame
Feb 2008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Walter Jauch, Prof. Dr.
Organizational Affiliation
Klinikum Grosshadern
Official's Role
Study Director
Facility Information:
Facility Name
Luwig Maximilians University - Klinikum Grosshadern
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

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

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