Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch

September 29, 2008 updated by: Sorlandet Hospital HF
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.

Study Overview

Status

Completed

Conditions

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.

  1. Are there special iv-indications? (CNS-infection, endocarditis, bone/joint infection, deep undrainable abscesses or foreign body infection)
  2. Is the oral route compromized? (unconscious, nausea, vomiting, diarrhoea, dysphagia, lack of cooperativeness)
  3. 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)
  4. Is the systemic inflammatory response syndrome present?
  5. Is the preferred antibiotics only available in intravenous form?
  6. 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

Observational

Enrollment (Actual)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Aust-Agder
      • Arendal, Aust-Agder, Norway, 4500
        • Sorlandet Sykehus Arendal
    • Vest Agder
      • Kristiansand, Vest Agder, Norway, 4604
        • Sørlandet Sykehus Kristiansand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Antibiotic switch

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

August 16, 2007

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

September 30, 2008

Last Update Submitted That Met QC Criteria

September 29, 2008

Last Verified

September 1, 2008

More Information

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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