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Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763373
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : September 30, 2008
Sponsor:
Information provided by:
Sorlandet Hospital HF

Tracking Information
First Submitted Date August 16, 2007
First Posted Date September 30, 2008
Last Update Posted Date September 30, 2008
Study Start Date November 2006
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2008)
Reduction in the amount of intravenous antibiotic days [ Time Frame: During stay ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 29, 2008)
Hospital stay duration, re-admittance, re-prescription of intravenous antibiotic therapy [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch
Official Title Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch
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.

  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
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Infection
Intervention Other: Implementation of antibiotic switch guidelines
Implementation of antibiotic switch guidelines
Other Name: Antibiotic switch
Study Groups/Cohorts
  • 1
    Observation group
  • 2
    Intervention group
    Intervention: Other: Implementation of antibiotic switch guidelines
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 29, 2008)
187
Original Actual Enrollment Same as current
Actual Study Completion Date March 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT00763373
Other Study ID Numbers Antibiotic Switch
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bjoern Waagsboe, Sorlandet Sykehus HF
Study Sponsor Sorlandet Hospital HF
Collaborators Not Provided
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
PRS Account Sorlandet Hospital HF
Verification Date September 2008