InfectionPhase 3NCT01572831
PCT and Clinical Algorithm for Determination of Duration of Antibiotics
A Phase 3 study testing PCT and clinical algorithm for stopping abx in people with Infection, run by Fraser Health at 1 site in Canada.
Trial summary
Patients in the ICU whose infection is resolving will be randomized to standard duration of antibiotics compared to duration determined by a combination of a procalcitonin value and a simple evaluation of clinical status. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Infection
- What is being tested?
- PCT and clinical algorithm for stopping abx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Sep 2013
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (19 years and older) treated with ABx for reasons other than prophylaxis within the last 24 hours and who are admitted to a critical care environment.
Who cannot join
- Declined consent
- Any infection that according to evidence-based guidelines which would usually receive more than 2 weeks of antibiotic therapy including, but not limited to;
- Infective endocarditis
- Osteomyelitis
- Undrained abscess
- Not expected to survive 48 hours
Show all 9Show fewer
- Immunosuppression (HIV positive, any immunosuppressive medications, any steroid dose, neutrophil count less than 1.0)
- Previously enrolled in this study
- Presently enrolled in a separate study which is felt by study investigators to have biological or clinical process in conflict with this study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
About this study
Official title: A Pilot Study to Evaluate a Procalcitonin-Based Algorithm for Duration of Antibiotic Therapy in Critically Ill Patients
Patients in the ICU whose infection is resolving will be randomized to standard duration of antibiotics compared to duration determined by a combination of a procalcitonin value and a simple evaluation of clinical status.
- Conditions
- Infection
- Being tested
- PCT and clinical algorithm for stopping abx
- Keywords
- antibiotic cessation rules, procalcitonin, infection, critical care
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCT and clinical algorithm for stopping abxOther
In the experimental arm, antibiotics will be stopped based upon the PCT-guided algorithm. This PCT algorithm also incorporates clinical parameters to ensure utmost safety for the patients. These clinical parameters are; resolution of fever (temperature less than 38.3 and greater than 36.0), shock (on no vasopressors), and leukocytosis (<12,000 and >4,000).
| Study group | Role | What they receive |
|---|---|---|
| standard care | No intervention | Abx will be determined by the managing physician |
| experimental arm | Experimental | Abx determined by normalization of PCT and basic clinical parameters Receives: Other: PCT and clinical algorithm for stopping abx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic- free days and alive at 14 days after ICU admission
Measured: 14 days
Secondary outcomes (8)
mortality at 28 days
Measured: 28 days
mortality at 90 days
Measured: 90 days
ventilator days at 28 days
Measured: 28 days
ICU free days at 28 days
Measured: 28 days
relapsed infection
Measured: 30 days
rates of CDAD
Measured: 30 days
colonization/infection with VRE/MRSA over next 30 days
Measured: 30 days
duration of abx in control arm for those with and without formal stewardship programs
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 posted6 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Reynolds, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572831
- Sponsor's protocol ID
- FHREB 2011-089
- Status last verified
- Apr 2012
- First submitted
- 4 Apr 2012
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate a Procalcitonin-Based Algorithm for Duration of Antibiotic Therapy in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01572831
- Acronym / sponsor ID
- FHREB 2011-089
- Conditions
- Infection
- Keywords
- antibiotic cessation rules, procalcitonin, infection, critical care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Apr 2012 (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.
Patients in the ICU whose infection is resolving will be randomized to standard duration of antibiotics compared to duration determined by a combination of a procalcitonin value and a simple evaluation of clinical status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –Abx will be determined by the managing physician |
| experimental arm | Experimental | Other: PCT and clinical algorithm for stopping abxAbx determined by normalization of PCT and basic clinical parameters |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (19 years and older) treated with ABx for reasons other than prophylaxis within the last 24 hours and who are admitted to a critical care environment.
Key exclusion criteria (9 listed)
- Declined consent
- Any infection that according to evidence-based guidelines which would usually receive more than 2 weeks of antibiotic therapy including, but not limited to;
- Not expected to survive 48 hours
- Immunosuppression (HIV positive, any immunosuppressive medications, any steroid dose, neutrophil count less than 1.0)
- Previously enrolled in this study
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 |
|---|---|---|
| PCT and clinical algorithm for stopping abxIn the experimental arm, antibiotics will be stopped based upon the PCT-guided algorithm. This PCT algorithm also incorporates clinical parameters to ensure utmost safety for the patients. These clinical parameters are; resolution of fever (temperature less than 38.3 and greater than 36.0), shock (on no vasopressors), and leukocytosis (<12,000 and >4,000). | Other | experimental arm |
Primary outcome
Antibiotic- free days and alive at 14 days after ICU admission
Time frame: 14 days
8 secondary outcomes
mortality at 28 days
Time frame: 28 days
mortality at 90 days
Time frame: 90 days
ventilator days at 28 days
Time frame: 28 days
ICU free days at 28 days
Time frame: 28 days
relapsed infection
Time frame: 30 days
rates of CDAD
Time frame: 30 days
colonization/infection with VRE/MRSA over next 30 days
Time frame: 30 days
duration of abx in control arm for those with and without formal stewardship programs
Time frame: 14 days
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 25 May 2015.
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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.
Steven Reynolds, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PCT and clinical algorithm for stopping abx in people with Infection, run by Fraser Health at 1 site in Canada.
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 1 inclusion and 9 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 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Antibiotic- free days and alive at 14 days after ICU admission (time frame: 14 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 25 May 2015.