Clinical trial NCT00233376: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Community-Acquired Infection
Cross Infection
Keywords: Decision support system
Causal probabilistic network
Antibiotics
Antibiotic resistance
Community-acquired infections
Cross-infections
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Eu Fifth Framework IST
First posted: 2005-10-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Appropriate antibiotic treatment
Secondary outcomes:
measure: Overall 30-day mortality
measure: Durations of fever
measure: Duration of hospital stay
measure: Antibiotic use
measure: Antibiotic costs
measure: Adverse events
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Department of Clinical Microbiology and Hospital Hygeine, Freiburg University Hospital
city: Petah Tikva
country: Israel
facility: Rabin Medical Center; Beilinson Campus
city: Rome
country: Italy
facility: Department of Infectious Diseases, Gemelli Hospital in Rome
Study officials:
affiliation: Rabin Medical Center, Beilinson Campus
name: Leonard Leibovici, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Model-based Medical Decision Support, Aalborg University
name: Steen Andreassen, PhD
role: STUDY_CHAIR
References: