Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch

Infection Clinical Trial

Official title:

Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763373
• Other study ID #: Antibiotic Switch
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2007
• Last updated: September 29, 2008
• Start date: November 2006
• Est. completion date: March 2007

Study information

• Verified date: September 2008
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical 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. Comparison of the amount of the iv-administration before and after the intervention.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: March 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Infection

Intervention

Other:
• Implementation of antibiotic switch guidelines
Implementation of antibiotic switch guidelines

Locations

Country	Name	City	State
Norway	Sorlandet Sykehus Arendal	Arendal	Aust-Agder
Norway	Sørlandet Sykehus Kristiansand	Kristiansand	Vest Agder

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the amount of intravenous antibiotic days		During stay	No
Secondary	Hospital stay duration, re-admittance, re-prescription of intravenous antibiotic therapy		4 weeks	No