NCT00431483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
779

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

February 1, 2007

Last Update Submit

September 25, 2013

Conditions

Bacterial Infections

Keywords

antibacterial agentssurgerypharmacisteconomics, pharmaceutical

Outcome Measures

Primary Outcomes (1)

  • overall duration of antibiotic therapy during study period

    Feb 2008

Secondary Outcomes (4)

  • iv to oral switch

    Feb 2008

  • compliance of treatment with hospital formulary for antibiotic therapy

    Feb 2008

  • cost of antibiotic therapy

    Feb 2008

  • number and duration of therapy with antibiotics with redundant spectra

    Feb 2008

Study Arms (1)

Pharmaceutical counseling

OTHER
Behavioral: pharmaceutical consulting

Interventions

pharmaceutical consultingBEHAVIORAL

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

Pharmaceutical counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luwig Maximilians University - Klinikum Grosshadern

Munich, Bavaria, 81377, Germany

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Karl-Walter Jauch, Prof. Dr.

    Klinikum Grosshadern

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacist

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 5, 2007

Study Start

February 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

September 26, 2013

Record last verified: 2013-09

Locations

DE(1)