Computerized Decision Support System for Antibiotic Treatment

Cross Infection Clinical Trial

Official title:

Improving Empirical Antibiotic Treatment Using TREAT,a Computerized Decision Support System. Cluster Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233376
• Other study ID #: IST-1999-11459
• Secondary ID: Fifth framework
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2005
• Last updated: July 17, 2006
• Start date: May 2004
• Est. completion date: November 2004

Study information

• Verified date: October 2005
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Community-Acquired Infection
• Community-Acquired Infections
• Cross Infection
• Infection

Intervention

Procedure:
• Access to an antibiotic decision support system

Behavioral:
• Distribution of local antibiotic guidelines

Locations

Country	Name	City	State
Germany	Department of Clinical Microbiology and Hospital Hygeine, Freiburg University Hospital	Freiburg
Israel	Rabin Medical Center; Beilinson Campus	Petah Tikva
Italy	Department of Infectious Diseases, Gemelli Hospital in Rome	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Eu Fifth Framework IST

Countries where clinical trial is conducted

Germany,  Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appropriate antibiotic treatment
Secondary	Overall 30-day mortality
Secondary	Durations of fever
Secondary	Duration of hospital stay
Secondary	Antibiotic use
Secondary	Antibiotic costs
Secondary	Adverse events

External Links

•   Project web site