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Computerized Decision Support System for Antibiotic Treatment

Primary Purpose

Community-Acquired Infection, Cross Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Access to an antibiotic decision support system
Distribution of local antibiotic guidelines
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-Acquired Infection focused on measuring Decision support system, Causal probabilistic network, Antibiotics, Antibiotic resistance, Community-acquired infections, Cross-infections

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients from whom blood cultures were drawn. Patients prescribed antibiotics (not for prophylaxis). Patients fulfilling sepsis diagnostic criteria. Patients with a focus of infection. Patients with shock compatible with septic shock. Patients with febrile neutropenia Exclusion Criteria: HIV positive patients with a current (suspected or identified) opportunistic disease and/or AIDS defining illness currently or within the past six months Organ or bone marrow transplant recipients Children <18 years; suspected travel infections or tuberculosis Pregnant women Re-entries

Sites / Locations

  • Department of Clinical Microbiology and Hospital Hygeine, Freiburg University Hospital
  • Rabin Medical Center; Beilinson Campus
  • Department of Infectious Diseases, Gemelli Hospital in Rome

Outcomes

Primary Outcome Measures

Appropriate antibiotic treatment

Secondary Outcome Measures

Overall 30-day mortality
Durations of fever
Duration of hospital stay
Antibiotic use
Antibiotic costs
Adverse events

Full Information

First Posted
October 4, 2005
Last Updated
July 17, 2006
Sponsor
Rabin Medical Center
Collaborators
Eu Fifth Framework IST
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1. Study Identification

Unique Protocol Identification Number
NCT00233376
Brief Title
Computerized Decision Support System for Antibiotic Treatment
Official Title
Improving Empirical Antibiotic Treatment Using TREAT,a Computerized Decision Support System. Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center
Collaborators
Eu Fifth Framework IST

4. Oversight

5. Study Description

Brief Summary
We developed a computerized decision support system for prescription of antibiotics to inpatients. The purpose of the study is to assess the performance of the system in different wards, in three different hospitals, in three countries.
Detailed Description
Antibiotic treatment for suspected moderate to severe bacterial infections is usually initiated empirically, prior to identification of the causative pathogen. Appropriate treatment, that is matching in-vitro susceptibilities of subsequently isolated pathogens, reduces the overall fatality rate of severe infections with adjusted odds ratios varying between 1.6 and 6.9. In the same studies, 20-50% of patients were given inappropriate empirical antibiotic treatment. We developed a computerized decision support system (TREAT) based on a causal probabilistic network to improve antibiotic treatment of inpatients. The aims of the system were to improve the rate of appropriate antibiotic treatment, thereby reducing mortality, and to route antibiotic use towards ecologically economical antibiotics as determined by local resistance profiles. The system can be calibrated to different locations. The TREAT system was tested in a multi-center observational cohort study. The study proved the system safe and effective. TREAT prescribed appropriate antibiotic treatment to 70% of patients, 58% of whom were treated appropriately by physicians. TREAT used a narrow antibiotic formulary and at lower costs, mainly lowering costs assigned by the model to future resistance. The system performed well in three different countries (Israel, Italy and Germany). We then proceeded to assess the effect of TREAT on the management of inpatients in these sites in a cluster randomized controlled trial. We used wards as the unit of randomization to avoid contamination through education of users by the system, and to benefit from the interaction of TREAT with the ward as a whole. Comparison: the TREAT system was installed in intervention wards and its use was offered to physicians at the time of empirical antibiotic treatment. Physicians were asked to inspect TREAT's result interface. The final choice of antibiotic treatment was theirs. Control wards had no access to the system. We assessed outcomes in intervention vs. control wards with regard to patient outcomes, appropriateness of antibiotic treatment and antibiotic costs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-Acquired Infection, Cross Infection
Keywords
Decision support system, Causal probabilistic network, Antibiotics, Antibiotic resistance, Community-acquired infections, Cross-infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Access to an antibiotic decision support system
Intervention Type
Behavioral
Intervention Name(s)
Distribution of local antibiotic guidelines
Primary Outcome Measure Information:
Title
Appropriate antibiotic treatment
Secondary Outcome Measure Information:
Title
Overall 30-day mortality
Title
Durations of fever
Title
Duration of hospital stay
Title
Antibiotic use
Title
Antibiotic costs
Title
Adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients from whom blood cultures were drawn. Patients prescribed antibiotics (not for prophylaxis). Patients fulfilling sepsis diagnostic criteria. Patients with a focus of infection. Patients with shock compatible with septic shock. Patients with febrile neutropenia Exclusion Criteria: HIV positive patients with a current (suspected or identified) opportunistic disease and/or AIDS defining illness currently or within the past six months Organ or bone marrow transplant recipients Children <18 years; suspected travel infections or tuberculosis Pregnant women Re-entries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard Leibovici, M.D.
Organizational Affiliation
Rabin Medical Center, Beilinson Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steen Andreassen, PhD
Organizational Affiliation
Center for Model-based Medical Decision Support, Aalborg University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Clinical Microbiology and Hospital Hygeine, Freiburg University Hospital
City
Freiburg
Country
Germany
Facility Name
Rabin Medical Center; Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Department of Infectious Diseases, Gemelli Hospital in Rome
City
Rome
Country
Italy

12. IPD Sharing Statement

Links:
URL
http://www.treat.dk
Description
Project web site

Learn more about this trial

Computerized Decision Support System for Antibiotic Treatment

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