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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00431483
Other study ID # AW2007
Secondary ID
Status Completed
Phase N/A
First received February 1, 2007
Last updated September 25, 2013
Start date February 2007
Est. completion date February 2008

Study information

Verified date September 2013
Source Ludwig-Maximilians - University of Munich
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 779
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
pharmaceutical consulting
to measure if information and advice by a pharmacist has an impact on quality and quantity of prescribed antibacterials

Locations

Country Name City State
Germany Luwig Maximilians University - Klinikum Grosshadern Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall duration of antibiotic therapy during study period Feb 2008 No
Secondary iv to oral switch number of courses of iv antibiotics switched to oral antibiotics; duration of iv treatment Feb 2008 No
Secondary compliance of treatment with hospital formulary for antibiotic therapy Feb 2008 No
Secondary cost of antibiotic therapy Feb 2008 No
Secondary number and duration of therapy with antibiotics with redundant spectra Feb 2008 No
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