InfectionsNCT01066013
Antimicrobial De-escalation Strategy in Medical Patients
A study testing Antimicrobial de-escalation strategy in people with Infections, run by Fraser Health.
Trial summary
The purpose of this pilot study is to assess the impact of an antibiotic de-escalation strategy on the clinical outcomes (clinical cure or improvement) of medical patients related to the usage of of broad-spectrum antimicrobial agents. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Infections
- What is being tested?
- Antimicrobial de-escalation strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Jun 2010
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 years and over
- Suspected or confirmed infection for which a Meropenem and/or Piperacillin/Tazobactam is prescribed. This will include any patient who is other concomitant antibiotic(s) such as Vancomycin
- Subject admitted to SMH medical unit(s)
- Pregnant patient (or patients wishing to become pregnant)
Who cannot join
- Age less than 19 years
- Granulocytopenia (< 1x109/L)
- Allergy or intolerance to meropenem or piperacillin-tazobactam.
- Febrile Neutropenia
- Cystic Fibrosis
About this study
The purpose of this pilot study is to assess the impact of an antibiotic de-escalation strategy on the clinical outcomes (clinical cure or improvement) of medical patients related to the usage of of broad-spectrum antimicrobial agents.
Read the detailed description
This is an open-label, case-control, pilot study involving medical patients with serious infections who are prescribed meropenem or piperacillin/tazobactam, at Surrey Memorial Hospital. Patients in the experimental arm (cases) will be required to provide an informed consent. A team consisting of an infectious diseases specialist, medical microbiologist and clinical pharmacists will prospectively assess antimicrobial therapy in the enrolled subjects in the prospective arm and make recommendations for antimicrobial de-escalation.
The control group will consist of subjects drawn from historic data of patients on the same medical unit(s) who will be matched based on age, sex, use of broadspectrum antibiotics (meropenem or piperacillin/tazobactam) and infectious diseases diagnosis.
- Conditions
- Infections
- Being tested
- Antimicrobial de-escalation strategy
- Keywords
- Antimicrobial De escalation, Meropenem, Piperacillin tazobactam, Medical patients, Appropriate use, Cost savings, Antimicrobial De-escalation strategy
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial de-escalation strategyOther
The antimicrobial de-escalation team will record recommendations for de-escalation in the patient's progress notes for the attending physicians to review and act upon as appropriate. The attending physician will be responsible for making changes to antimicrobial therapy and following up on patient progress as per the usual practice.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Antimicrobial de-escalation arm | Experimental | Antimicrobial de escalation team will assess therapy and make recommendations to (a) change to antibiotic(s) with narrow spectrum,(b) stop antibiotics, (c) order new cultures/investigations or (d) consult with specialists or ID service for full evaluation (if patient's condition is worsening). Receives: Other: Antimicrobial de-escalation strategy |
| Restrospective control arm | No intervention | The control subjects will be drawn from historic data of patients on the same medical unit(s) and will be matched based on age, antibiotics, sex, and infectious diseases diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.
Measured: 7 days
Secondary outcomes (5)
Clinical efficacy (clinical improvement or complete resolution of infection)
Measured: 7 days
Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation
Measured: 7 days
Cost and consumption (usage data) of antibiotics
Measured: 7 days
All cause mortality
Measured: 14 days
Length of stay in the hospital
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066013
- Sponsor's protocol ID
- FHREB 2009-093
- Status last verified
- Jan 2010
- First submitted
- 1 Feb 2010
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial De-escalation Strategy in Medical Patients
- ClinicalTrials.gov ID
- NCT01066013
- Acronym / sponsor ID
- FHREB 2009-093
- Conditions
- Infections
- Keywords
- Antimicrobial De escalation, Meropenem, Piperacillin tazobactam, Medical patients, Appropriate use, Cost savings, Antimicrobial De-escalation strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- Vancouver Foundation
- Study start
- Feb 2010
- Primary completion
- May 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 10 Feb 2010 (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.
The purpose of this pilot study is to assess the impact of an antibiotic de-escalation strategy on the clinical outcomes (clinical cure or improvement) of medical patients related to the usage of of broad-spectrum antimicrobial agents.
Detailed description
This is an open-label, case-control, pilot study involving medical patients with serious infections who are prescribed meropenem or piperacillin/tazobactam, at Surrey Memorial Hospital. Patients in the experimental arm (cases) will be required to provide an informed consent. A team consisting of an infectious diseases specialist, medical microbiologist and clinical pharmacists will prospectively assess antimicrobial therapy in the enrolled subjects in the prospective arm and make recommendations for antimicrobial de-escalation.
The control group will consist of subjects drawn from historic data of patients on the same medical unit(s) who will be matched based on age, sex, use of broadspectrum antibiotics (meropenem or piperacillin/tazobactam) and infectious diseases diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Antimicrobial de-escalation arm | Experimental | Other: Antimicrobial de-escalation strategyAntimicrobial de escalation team will assess therapy and make recommendations to (a) change to antibiotic(s) with narrow spectrum,(b) stop antibiotics, (c) order new cultures/investigations or (d) consult with specialists or ID service for full evaluation (if patient's condition is worsening). |
| Restrospective control arm | No intervention | –The control subjects will be drawn from historic data of patients on the same medical unit(s) and will be matched based on age, antibiotics, sex, and infectious diseases diagnosis. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 19 years and over
- Suspected or confirmed infection for which a Meropenem and/or Piperacillin/Tazobactam is prescribed. This will include any patient who is other concomitant antibiotic(s) such as Vancomycin
- Subject admitted to SMH medical unit(s)
- Pregnant patient (or patients wishing to become pregnant)
Key exclusion criteria (5 listed)
- Age less than 19 years
- Granulocytopenia (< 1x109/L)
- Allergy or intolerance to meropenem or piperacillin-tazobactam.
- Febrile Neutropenia
- Cystic Fibrosis
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 |
|---|---|---|
| Antimicrobial de-escalation strategyThe antimicrobial de-escalation team will record recommendations for de-escalation in the patient's progress notes for the attending physicians to review and act upon as appropriate. The attending physician will be responsible for making changes to antimicrobial therapy and following up on patient progress as per the usual practice. | Other | Prospective Antimicrobial de-escalation arm |
Primary outcome
Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.
Time frame: 7 days
5 secondary outcomes
Clinical efficacy (clinical improvement or complete resolution of infection)
Time frame: 7 days
Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation
Time frame: 7 days
Cost and consumption (usage data) of antibiotics
Time frame: 7 days
All cause mortality
Time frame: 14 days
Length of stay in the hospital
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial de-escalation strategy in people with Infections, run by Fraser Health.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team. (time frame: 7 days). 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 Aug 2010.