Severe SepsisPhase 4Pro-SEPSNCT01025180
Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection
A Phase 4 study testing Procalcitonin level in people with Severe Sepsis, run by Brahms France at 9 sites in France.
Trial summary
A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Procalcitonin level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 9 sitesFrance
- Study dates
- Dec 2007to Mar 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalized in resuscitation ward
- severe sepsis symptomatology
- at least 2 SIRS criteria
- no infectious etiology detected
- at least one organ deficiency
Who cannot join
- the presence of a pathogen agent or infectious centre clearly identified
- pregnancy
- burned
- patients with therapeutic limitation
- recent surgery
- secondary neutropenia
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
ICU in J.Minjoz hospital
Besançon, 25030
ICU in Avicenne hospital
Bobigny, 93009
ICU in Ambroise Paré hospital
Boulogne, 92100
ICU in Raymond Poincaré hospital
Garches, 92380
ICU in André Boulloche hospital
Montbéliard, 25200
ICU in Centre hospitalier général
Mulhouse Belfort, 90000
ICU in St Etienne hospital
Saint-Etienne, 42055
ICU in Purpan hospital
Toulouse, 31059
ICU in Rangueil hospital
Toulouse, 31059
About this study
Official title: Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection
A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.
The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre.
Read more
This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group)
140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified.
The primary outcome is the rate of patients undergoing antibiotic treatment at D5.
Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5.
Duration of patient enrollment is 30 days.
- Conditions
- Severe Sepsis
- Being tested
- Procalcitonin level
- Keywords
- safety, Procalcitonin, PCT, SOFA, Sepsis, Antibiotic, Strategy, SIRS, severe sepsis without obvious infection
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin levelOther
The duration of antibiotic treatment is based on PCT level:
- < 0.25 ng/ml: antibiotic should be stopped
- 0.25 < PCT <0.5: antibiotic prescription is not recommended
- > 0.5 ng/ml: antibiotic should be used
| Study group | Role | What they receive |
|---|---|---|
| Procalcitonin level | Other | duration of the antibiotic treatment guided by procalcitonin level Receives: Other: Procalcitonin level |
| physician's appreciation | No intervention | duration of the antibiotic treatment based on physician's appreciation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patients undergoing antibiotic treatment at D5.
Measured: at D5
Secondary outcomes (1)
evolution of the SOFA score between D0, D3 and D5.
Measured: D30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startDec 2007
- Primary completionJan 2010
- Study completionMar 2010
Why it stopped: 65 patients were included after 2 years instead of 140
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brahms France
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Djillali Annane, Professor, Principal investigator, Raymond Poincaré hospital Garches-France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025180
- Sponsor's protocol ID
- PCT-F-2005-10
- Acronym
- Pro-SEPS
- Status last verified
- Dec 2009
- First submitted
- 1 Dec 2009
- Last updated
- 6 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection
- ClinicalTrials.gov ID
- NCT01025180
- Acronym / sponsor ID
- Pro-SEPS / PCT-F-2005-10
- Conditions
- Severe Sepsis
- Keywords
- safety, Procalcitonin, PCT, SOFA, Sepsis, Antibiotic, Strategy, SIRS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 65 patients were included after 2 years instead of 140
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Brahms FranceIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 3 Dec 2009 (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.
A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.
The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre.
This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group)
140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified.
The primary outcome is the rate of patients undergoing antibiotic treatment at D5.
Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5.
Duration of patient enrollment is 30 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procalcitonin level | Other | Other: Procalcitonin levelduration of the antibiotic treatment guided by procalcitonin level |
| physician's appreciation | No intervention | –duration of the antibiotic treatment based on physician's appreciation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hospitalized in resuscitation ward
- severe sepsis symptomatology
- at least 2 SIRS criteria
- no infectious etiology detected
- at least one organ deficiency
Key exclusion criteria (6 listed)
- the presence of a pathogen agent or infectious centre clearly identified
- pregnancy
- burned
- patients with therapeutic limitation
- recent surgery
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 |
|---|---|---|
| Procalcitonin levelThe duration of antibiotic treatment is based on PCT level: * < 0.25 ng/ml: antibiotic should be stopped * 0.25 < PCT <0.5: antibiotic prescription is not recommended * > 0.5 ng/ml: antibiotic should be used | Other | Procalcitonin level |
Primary outcome
rate of patients undergoing antibiotic treatment at D5.
Time frame: at D5
1 secondary outcome
evolution of the SOFA score between D0, D3 and D5.
Time frame: D30
Results and safety
The study was stopped early (reason given: 65 patients were included after 2 years instead of 140). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 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.
Djillali Annane, Professor principal investigator
Raymond Poincaré hospital Garches-France
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Procalcitonin level in people with Severe Sepsis, run by Brahms France at 9 sites in France.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 6 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: 65 patients were included after 2 years instead of 140). 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?
rate of patients undergoing antibiotic treatment at D5. (time frame: at D5). 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 6 Dec 2010.