NCT00233376

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2004

Shorter than P25 for phase_3

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
Last Updated

July 18, 2006

Status Verified

October 1, 2005

First QC Date

October 4, 2005

Last Update Submit

July 17, 2006

Conditions

Community-Acquired InfectionCross Infection

Keywords

Decision support systemCausal probabilistic networkAntibioticsAntibiotic resistanceCommunity-acquired infectionsCross-infections

Outcome Measures

Primary Outcomes (1)

  • Appropriate antibiotic treatment

Secondary Outcomes (6)

  • Overall 30-day mortality

  • Durations of fever

  • Duration of hospital stay

  • Antibiotic use

  • Antibiotic costs

  • +1 more secondary outcomes

Interventions

Access to an antibiotic decision support systemPROCEDURE
Distribution of local antibiotic guidelinesBEHAVIORAL

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Clinical Microbiology and Hospital Hygeine, Freiburg University Hospital

Freiburg im Breisgau, Germany

Location

Rabin Medical Center; Beilinson Campus

Petah Tikva, 49100, Israel

Location

Department of Infectious Diseases, Gemelli Hospital in Rome

Rome, Italy

Location

Related Links

MeSH Terms

Conditions

Community-Acquired InfectionsCross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Leonard Leibovici, M.D.

    Rabin Medical Center, Beilinson Campus

    PRINCIPAL INVESTIGATOR

  • Steen Andreassen, PhD

    Center for Model-based Medical Decision Support, Aalborg University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 5, 2005

Study Start

May 1, 2004

Study Completion

November 1, 2004

Last Updated

July 18, 2006

Record last verified: 2005-10

Locations

IL(1)IT(1)DE(1)