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Computerized Decision Support System for Antibiotic Treatment

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00233376
Enrollment
1500
Registered
2005-10-05
Start date
2004-05-31
Completion date
2004-11-30
Last updated
2006-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-Acquired Infection, Cross Infection

Keywords

Decision support system, Causal probabilistic network, Antibiotics, Antibiotic resistance, Community-acquired infections, Cross-infections

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.

Interventions

PROCEDUREAccess to an antibiotic decision support system
BEHAVIORALDistribution of local antibiotic guidelines

Sponsors

Eu Fifth Framework IST
CollaboratorUNKNOWN
Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Appropriate antibiotic treatment

Secondary

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

Countries

Germany, Israel, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026