Community-Acquired InfectionPhase 3NCT00233376
Computerized Decision Support System for Antibiotic Treatment
A Phase 3 study testing Access to an antibiotic decision support system and Distribution of local antibiotic guidelines in people with Community-Acquired Infection and Cross Infection, run by Rabin Medical Center at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Community-Acquired Infection, Cross Infection
- What is being tested?
- Access to an antibiotic decision support system and Distribution of local antibiotic guidelines
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2004to Nov 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Department of Clinical Microbiology and Hospital Hygeine, Freiburg University Hospital
Freiburg im Breisgau
About this study
Official title: Improving Empirical Antibiotic Treatment Using TREAT,a Computerized Decision Support System. Cluster Randomized Trial
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.
Read the 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.
- Conditions
- Community-Acquired Infection, Cross Infection
- Being tested
- Access to an antibiotic decision support system, Distribution of local antibiotic guidelines
- Keywords
- Decision support system, Causal probabilistic network, Antibiotics, Antibiotic resistance, Community-acquired infections, Cross-infections
- Medical subject headings
- Community-Acquired Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to an antibiotic decision support systemProcedure or surgery
Distribution of local antibiotic guidelinesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate antibiotic treatment
Secondary outcomes (6)
Overall 30-day mortality
Durations of fever
Duration of hospital stay
Antibiotic use
Antibiotic costs
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startMay 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Acquired InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eu Fifth Framework IST
- Investigators
- Leonard Leibovici, M.D., Principal investigator, Rabin Medical Center, Beilinson CampusSteen Andreassen, PhD, Study chair, Center for Model-based Medical Decision Support, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233376
- Sponsor's protocol ID
- IST-1999-11459
- Other IDs
- Fifth framework IST-1999-11459
- Status last verified
- Oct 2005
- First submitted
- 4 Oct 2005
- Last updated
- 18 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Empirical Antibiotic Treatment Using TREAT,a Computerized Decision Support System. Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT00233376
- Acronym / sponsor ID
- IST-1999-11459
- Conditions
- Community-Acquired Infection, Cross Infection
- Keywords
- Decision support system, Causal probabilistic network, Antibiotics, Antibiotic resistance, Community-acquired infections, Cross-infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Eu Fifth Framework IST
- Study start
- May 2004
- Study completion
- Nov 2004
- First posted
- 5 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to an antibiotic decision support system | Procedure or surgery | – |
| Distribution of local antibiotic guidelines | Behavioural | – |
Primary outcome
Appropriate antibiotic treatment
6 secondary outcomes
Overall 30-day mortality
Durations of fever
Duration of hospital stay
Antibiotic use
Antibiotic costs
Adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2006.
- Project web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard Leibovici, M.D. principal investigator
Rabin Medical Center, Beilinson Campus
Steen Andreassen, PhD study chair
Center for Model-based Medical Decision Support, Aalborg University
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Access to an antibiotic decision support system and Distribution of local antibiotic guidelines in people with Community-Acquired Infection and Cross Infection, run by Rabin Medical Center at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Israel, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriate antibiotic treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2006.