Clinical trial NCT00763373: Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch
Official title: Unnecessary IV Antibiotic Days Using General Criteria for Antibiotic Switch
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Lower respiratory infection
Upper respiratory infection
Urinary tract infection
Soft tissue infection
Hepatobiliary infection
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2008-09-30
Enrollment: 187
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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

Primary outcomes:
measure: Reduction in the amount of intravenous antibiotic days
timeFrame: During stay
Secondary outcomes:
measure: Hospital stay duration, re-admittance, re-prescription of intravenous antibiotic therapy
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sorlandet Sykehus Arendal
state: Aust-Agder
city: Kristiansand
country: Norway
facility: Sørlandet Sykehus Kristiansand
state: Vest Agder
Study officials:
affiliation: Medical department Kristiansand
name: Bjoern Waagsboe, Ass dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical dep kristiansand
name: Anders Sundoy, Chief Doc
role: STUDY_DIRECTOR
affiliation: Med dep Arendal
name: Else Quist Paulsen, ass doc
role: STUDY_DIRECTOR
References: