Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch
Primary Purpose
Infection
Status
Completed
Phase
Locations
Norway
Study Type
Observational
Intervention
Implementation of antibiotic switch guidelines
Sponsored by
About this trial
This is an observational trial for Infection focused on measuring Lower respiratory infection, Upper respiratory infection, Urinary tract infection, Soft tissue infection, Hepatobiliary infection
Eligibility Criteria
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
Sites / Locations
- Sorlandet Sykehus Arendal
- Sørlandet Sykehus Kristiansand
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
1
2
Arm Description
Observation group
Intervention group
Outcomes
Primary Outcome Measures
Reduction in the amount of intravenous antibiotic days
Secondary Outcome Measures
Hospital stay duration, re-admittance, re-prescription of intravenous antibiotic therapy
Full Information
NCT ID
NCT00763373
First Posted
August 16, 2007
Last Updated
September 29, 2008
Sponsor
Sorlandet Hospital HF
1. Study Identification
Unique Protocol Identification Number
NCT00763373
Brief Title
Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch
Official Title
Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch
Study Type
Observational
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sorlandet Hospital HF
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Observation of the use of intravenous antibiotics in medical clinic of Sorlandet Hospital, Norway. Suggestions of criteria for the switch from intravenous to oral administration of antibiotics. Implementation of the criteria and new registration of the use of intravenous antibiotics. Comparison of the amount of the iv-administration before and after the intervention.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Lower respiratory infection, Upper respiratory infection, Urinary tract infection, Soft tissue infection, Hepatobiliary infection
7. Study Design
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Description
Observation group
Arm Title
2
Arm Description
Intervention group
Intervention Type
Other
Intervention Name(s)
Implementation of antibiotic switch guidelines
Other Intervention Name(s)
Antibiotic switch
Intervention Description
Implementation of antibiotic switch guidelines
Primary Outcome Measure Information:
Title
Reduction in the amount of intravenous antibiotic days
Time Frame
During stay
Secondary Outcome Measure Information:
Title
Hospital stay duration, re-admittance, re-prescription of intravenous antibiotic therapy
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjoern Waagsboe, Ass dr
Organizational Affiliation
Medical department Kristiansand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anders Sundoy, Chief Doc
Organizational Affiliation
Medical dep kristiansand
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Else Quist Paulsen, ass doc
Organizational Affiliation
Med dep Arendal
Official's Role
Study Director
Facility Information:
Facility Name
Sorlandet Sykehus Arendal
City
Arendal
State/Province
Aust-Agder
ZIP/Postal Code
4500
Country
Norway
Facility Name
Sørlandet Sykehus Kristiansand
City
Kristiansand
State/Province
Vest Agder
ZIP/Postal Code
4604
Country
Norway
12. IPD Sharing Statement
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Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch
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