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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexandra Weber, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00431483
First received: February 1, 2007
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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 Intervention
Bacterial Infections
Behavioral: pharmaceutical consulting

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • overall duration of antibiotic therapy during study period [ Time Frame: Feb 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • iv to oral switch [ Time Frame: Feb 2008 ] [ Designated as safety issue: No ]
    number of courses of iv antibiotics switched to oral antibiotics; duration of iv treatment

  • compliance of treatment with hospital formulary for antibiotic therapy [ Time Frame: Feb 2008 ] [ Designated as safety issue: No ]
  • cost of antibiotic therapy [ Time Frame: Feb 2008 ] [ Designated as safety issue: No ]
  • number and duration of therapy with antibiotics with redundant spectra [ Time Frame: Feb 2008 ] [ Designated as safety issue: No ]

Enrollment: 779
Study Start Date: February 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pharmaceutical counseling Behavioral: pharmaceutical consulting
to measure if information and advice by a pharmacist has an impact on quality and quantity of prescribed antibacterials

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Alexandra Weber, Pharmacist, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00431483     History of Changes
Other Study ID Numbers: AW2007
Study First Received: February 1, 2007
Last Updated: September 25, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on November 25, 2014