- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00763373
Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a comparison of the use of intravenous antibiotics before and after the implementation of switch criteria. Switch is defined as a change in administration route from intravenous to oral.
Patients administered to medical department at Sorlandet hospital in Kristiansand and Arendal are included if they are receiving intravenous antibiotics. Pediatric department is not included. Patients that are already hospitalized and given intravenous antibiotics are also included.
Patients that are excluded are those with CNS-infection, endocarditis, bone/joint infection, deep undrainable abscesses and those with foreign body infection.
Switch criteria are made from a thorough investigation on earlier switch studies. We have collected several studies on this topic, but none from the nordic countries.
The intervention contributes the following: The implementation of a registration form where doctors are prone to answer six questions when they evaluate antibiotic administration form.
- Are there special iv-indications? (CNS-infection, endocarditis, bone/joint infection, deep undrainable abscesses or foreign body infection)
- Is the oral route compromized? (unconscious, nausea, vomiting, diarrhoea, dysphagia, lack of cooperativeness)
- Is the patients suffering from immunosuppression? (leukopenia, cytotoxic treatment, transplantation, steroids >10mg, TNF-alfa inhibitor treatment, unregulated diabetes mellitus (HbA1C >10), uremia (serum-creatinine > 300), HIV, AIDS, lymphoma, multiple myelomas, cystic fibrosis, asplenic)
- Is the systemic inflammatory response syndrome present?
- Is the preferred antibiotics only available in intravenous form?
- Are there any other special reasons for intravenous antibiotics?
If the doctor can answer NO to all these questions, then the patient is a candidate for antibiotic switch from day three after hospitalization. This evaluation form follows the other medical registration forms from day to day.
The intervention also includes
- A lecture by the study group to all our medical doctors.
- Information by e-mail to all our medical doctors
- Information by letters to all our medical doctors and chief nurses
Registration of parameters used for evaluating antibiotic switch is done three times a week by the study group. We register date and patient information, if other medication is taken orally, heart rate, respiratory rate, temperature, biochemical parameters (CRP and leukocytes), diagnosis and antibiotic choice.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Aust-Agder
-
Arendal, Aust-Agder, Norway, 4500
- Sorlandet Sykehus Arendal
-
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Vest Agder
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Kristiansand, Vest Agder, Norway, 4604
- Sørlandet Sykehus Kristiansand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Alle patients with suspected infection and who is gives intravenous antibiotics
Exclusion Criteria:
- CNS-infection
- Endocarditis
- Bone/joint infection
- Undrained abscess
- Foreign body infection
- Compromized oral route
- Immunosuppression
- Patients meeting the systemic inflammatory response syndrome criteria
- No preferred oral antibiotic available
- Other conditions requiring intravenous administration
Study Plan
How is the study designed?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Observation group
|
|
|
2
Intervention group
|
Implementation of antibiotic switch guidelines
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction in the amount of intravenous antibiotic days
Time Frame: During stay
|
During stay
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hospital stay duration, re-admittance, re-prescription of intravenous antibiotic therapy
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bjoern Waagsboe, Ass dr, Medical department Kristiansand
- Study Director: Anders Sundoy, Chief Doc, Medical dep kristiansand
- Study Director: Else Quist Paulsen, ass doc, Med dep Arendal
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Antibiotic Switch
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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