Bacterial InfectionsNCT00431483
Clinical and Economic Impact of Interventions by a Clinical Pharmacist on Antibiotic Use on Surgical Wards
A study testing pharmaceutical consulting in people with Bacterial Infections, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- pharmaceutical consulting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 779 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2007to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female and male patients receiving antibiotics for a proven or suspected infection on designated surgical wards
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Luwig Maximilians University - Klinikum Grosshadern
Munich, Bavaria, 81377
About this study
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.
Read the 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.
- Conditions
- Bacterial Infections
- Being tested
- pharmaceutical consulting
- Keywords
- antibacterial agents, surgery, pharmacist, economics, pharmaceutical
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical consultingBehavioural
to measure if information and advice by a pharmacist has an impact on quality and quantity of prescribed antibacterials
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical counseling | Other | Not described Receives: Behavioral: pharmaceutical consulting |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall duration of antibiotic therapy during study period
Measured: Feb 2008
Secondary outcomes (4)
iv to oral switch
number of courses of iv antibiotics switched to oral antibiotics; duration of iv treatment
Measured: Feb 2008
compliance of treatment with hospital formulary for antibiotic therapy
Measured: Feb 2008
cost of antibiotic therapy
Measured: Feb 2008
number and duration of therapy with antibiotics with redundant spectra
Measured: Feb 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Weber, Ludwig-Maximilians - University of Munich
- Investigators
- Karl-Walter Jauch, Prof. Dr., Study director, Klinikum Grosshadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431483
- Sponsor's protocol ID
- AW2007
- Status last verified
- Sep 2013
- First submitted
- 1 Feb 2007
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Impact of Interventions by a Clinical Pharmacist on Antibiotic Use on Surgical Wards
- ClinicalTrials.gov ID
- NCT00431483
- Acronym / sponsor ID
- AW2007
- Conditions
- Bacterial Infections
- Keywords
- antibacterial agents, surgery, pharmacist, economics, pharmaceutical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 779 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 5 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical counseling | Other | Behavioral: pharmaceutical consulting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female and male patients receiving antibiotics for a proven or suspected infection on designated surgical wards
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmaceutical consultingto measure if information and advice by a pharmacist has an impact on quality and quantity of prescribed antibacterials | Behavioural | Pharmaceutical counseling |
Primary outcome
overall duration of antibiotic therapy during study period
Time frame: Feb 2008
4 secondary outcomes
iv to oral switch
Time frame: Feb 2008
compliance of treatment with hospital formulary for antibiotic therapy
Time frame: Feb 2008
cost of antibiotic therapy
Time frame: Feb 2008
number and duration of therapy with antibiotics with redundant spectra
Time frame: Feb 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl-Walter Jauch, Prof. Dr. study director
Klinikum Grosshadern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmaceutical consulting in people with Bacterial Infections, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall duration of antibiotic therapy during study period (time frame: Feb 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2013.