Computerized Decision Support System for Antibiotic Treatment
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|ClinicalTrials.gov Identifier: NCT00233376|
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : July 18, 2006
|Condition or disease||Intervention/treatment||Phase|
|Community-Acquired Infection Cross Infection||Procedure: Access to an antibiotic decision support system Behavioral: Distribution of local antibiotic guidelines||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Empirical Antibiotic Treatment Using TREAT,a Computerized Decision Support System. Cluster Randomized Trial|
|Study Start Date :||May 2004|
|Study Completion Date :||November 2004|
- Appropriate antibiotic treatment
- Overall 30-day mortality
- Durations of fever
- Duration of hospital stay
- Antibiotic use
- Antibiotic costs
- Adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233376
|Department of Clinical Microbiology and Hospital Hygeine, Freiburg University Hospital|
|Rabin Medical Center; Beilinson Campus|
|Petah Tikva, Israel, 49100|
|Department of Infectious Diseases, Gemelli Hospital in Rome|
|Principal Investigator:||Leonard Leibovici, M.D.||Rabin Medical Center, Beilinson Campus|
|Study Chair:||Steen Andreassen, PhD||Center for Model-based Medical Decision Support, Aalborg University|