Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch

This study has been completed.
Sponsor:
Information provided by:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00763373
First received: August 16, 2007
Last updated: September 29, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Infection
Other: Implementation of antibiotic switch guidelines
Phase 3

Study Type: Observational
Official Title: Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Reduction in the amount of intravenous antibiotic days [ Time Frame: During stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital stay duration, re-admittance, re-prescription of intravenous antibiotic therapy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 187
Study Start Date: November 2006
Study Completion Date: March 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Observation group
2
Intervention group
Other: Implementation of antibiotic switch guidelines
Implementation of antibiotic switch guidelines
Other Name: Antibiotic switch

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763373

Locations
Norway
Sorlandet Sykehus Arendal
Arendal, Aust-Agder, Norway, 4500
Sørlandet Sykehus Kristiansand
Kristiansand, Vest Agder, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
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
  More Information

No publications provided

Responsible Party: Bjoern Waagsboe, Sorlandet Sykehus HF
ClinicalTrials.gov Identifier: NCT00763373     History of Changes
Other Study ID Numbers: Antibiotic Switch
Study First Received: August 16, 2007
Last Updated: September 29, 2008
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Sorlandet Hospital HF:
Lower respiratory infection
Upper respiratory infection
Urinary tract infection
Soft tissue infection
Hepatobiliary infection

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 23, 2014