InfectionNCT00763373
Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch
An observational study of Infection, run by Sorlandet Hospital HF at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Implementation of antibiotic switch guidelines
- How many people
- 187 participants
- Where
- 2 sitesNorway
- Study dates
- Nov 2006to Mar 2007
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Alle patients with suspected infection and who is gives intravenous antibiotics
Who cannot join
- CNS-infection
- Endocarditis
- Bone/joint infection
- Undrained abscess
- Foreign body infection
- Compromized oral route
Show all 10Show fewer
- Immunosuppression
- Patients meeting the systemic inflammatory response syndrome criteria
- No preferred oral antibiotic available
- Other conditions requiring intravenous administration
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Sorlandet Sykehus Arendal
Arendal, Aust-Agder, 4500
Sørlandet Sykehus Kristiansand
Kristiansand, Vest Agder, 4604
About this study
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.
Read the 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.
- Conditions
- Infection
- Being tested
- Implementation of antibiotic switch guidelines
- Keywords
- Lower respiratory infection, Upper respiratory infection, Urinary tract infection, Soft tissue infection, Hepatobiliary infection
- Medical subject headings
- Infections, Respiratory Tract Infections, Urinary Tract Infections, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of antibiotic switch guidelinesOther
Also called Antibiotic switch
Implementation of antibiotic switch guidelines
| Study group | Role | What they receive |
|---|---|---|
| 1 | Observation group | |
| 2 | Intervention group Receives: Other: Implementation of antibiotic switch guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the amount of intravenous antibiotic days
Measured: During stay
Secondary outcomes (1)
Hospital stay duration, re-admittance, re-prescription of intravenous antibiotic therapy
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startNov 2006
- Primary completionJan 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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
- Observational
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Investigators
- Bjoern Waagsboe, Ass dr, Principal investigator, Medical department KristiansandAnders Sundoy, Chief Doc, Study director, Medical dep kristiansandElse Quist Paulsen, ass doc, Study director, Med dep Arendal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763373
- Sponsor's protocol ID
- Antibiotic Switch
- Status last verified
- Sep 2008
- First submitted
- 16 Aug 2007
- Last updated
- 30 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch
- ClinicalTrials.gov ID
- NCT00763373
- Acronym / sponsor ID
- Antibiotic Switch
- Conditions
- Infection
- Keywords
- Lower respiratory infection, Upper respiratory infection, Urinary tract infection, Soft tissue infection, Hepatobiliary infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Nov 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 30 Sep 2008 (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.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Observation group |
| 2 | – | Other: Implementation of antibiotic switch guidelinesIntervention group |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Alle patients with suspected infection and who is gives intravenous antibiotics
Key exclusion criteria (10 listed)
- CNS-infection
- Endocarditis
- Bone/joint infection
- Undrained abscess
- Foreign body infection
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 |
|---|---|---|
| Implementation of antibiotic switch guidelinesAlso: Antibiotic switchImplementation of antibiotic switch guidelines | Other | 2 |
Primary outcome
Reduction in the amount of intravenous antibiotic days
Time frame: During stay
1 secondary outcome
Hospital stay duration, re-admittance, re-prescription of intravenous antibiotic therapy
Time frame: 4 weeks
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 30 Sep 2008.
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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.
Bjoern Waagsboe, Ass dr principal investigator
Medical department Kristiansand
Anders Sundoy, Chief Doc study director
Medical dep kristiansand
Else Quist Paulsen, ass doc study director
Med dep Arendal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Sorlandet Hospital HF at 2 sites in Norway.
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 10 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 30 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Reduction in the amount of intravenous antibiotic days (time frame: During stay). 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 30 Sep 2008.