SepsisPhase 4NCT00250666
Procalcitonin-Guided Antimicrobial Discontinuation
A Phase 4 study testing PCT measurement in people with Sepsis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The current study aims to validate the diagnostic use of PCT assessing its capability to individualize and shorten the duration of antibiotic therapy in critically ill patients with suspected or confirmed sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- PCT measurement
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to May 2007
- 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
- Patients with clinically suspected or microbiologically confirmed bacterial sepsis
- Informed consent
Who cannot join
- Patients with microbiologically documented infections caused by the following microorganisms: Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis, Staphylococcus aureus
- Patients with fungal infections
- Patients with severe infections due to viruses or parasites (e.g. hemorrhagic fever, malaria)
- Patients with suspected or confirmed bacterial meningitis or endocarditis
- Patients with localized, deep-seated abscesses (e.g. brain abscess) without systemic sepsis
- Patients with chronic, localized infections (e.g. chronic osteomyelitis) without systemic sepsis
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- Neutropenic and other severely immuno-compromised patients (patients infected with human immunodeficiency virus and a CD4 count < 200; patients on immuno-suppressive therapy after solid organ transplantation; patients with cystic fibrosis)
- Withholding of life-support
- Early discharge or death (< 24 hours after admission)
- Complete absence of antimicrobial treatment despite suspicion of sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Procalcitonin-Guided Antimicrobial Discontinuation Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Sepsis
The current study aims to validate the diagnostic use of PCT assessing its capability to individualize and shorten the duration of antibiotic therapy in critically ill patients with suspected or confirmed sepsis.
In particular, no well-designed intervention study has properly examined the following hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic treatment duration in critically ill patients with suspected or documented sepsis, without harming patient safety.
Read the detailed description
Primary objective:
To assess the effect of repeated PCT measurements in critically ill patients with clinically suspected or microbiologically documented sepsis on duration of antimicrobial use and to compare this strategy to standard clinical practice, by using an improved PCT assay with a sensitivity of 0.06 ng/ml.
Secondary objectives:
To determine the impact of repeated PCT measurements on patient outcome (morbidity, mortality, emergence of antibiotic resistance and nosocomial super-infections).
Main measures:
Primary:
- Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure) Secondary:
- Cure and failure rate of infection (in N recurrent infections per 100 patients)
- 28-day case-fatality rate (in N deaths per 100 patients)
- Length of hospital stay (in days)
- Costs of antimicrobial therapy (in CHF)
- Rate of nosocomial super-infection (in N super-infections per 100 patients)
- Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-days)
- Conditions
- Sepsis
- Being tested
- PCT measurement
- Keywords
- Biological Markers, Procalcitonin, Critical Care, Diagnosis, Differential, Prospective Study, Sepsis, Antibiotic stewardship, Antimicrobial resistance
- Medical subject headings
- Sepsis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCT measurementProcedure or surgery
Peripheral blood samples were collected in the morning, using vacuum tubes (BD Vacutainer SST II Plus plastic tubes; Becton Dickinson Diagnostic Systems, Allschwil, Switzerland). Circulating plasma PCT levels were measured with a time-resolved amplified cryptate emission technology assay (Kryptor PCT; Brahms AG, Hennigsdorf, Germany), with an assay sensitivity of 0.06 mg/L, approximately fourfold above mean normal levels. Measurements were performed 7 days a week.
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
Secondary outcomes (6)
Cure and failure rate of infection (in N recurrent infections per 100 patients)
28-day case-fatality rate (in N deaths per 100 patients)
Length of hospital stay (in days)
Costs of antimicrobial therapy (in CHF)
Rate of nosocomial super-infection (in N super-infections per 100 patients)
Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startJan 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Stephan J Harbarth, MD MS, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250666
- Sponsor's protocol ID
- HUG 05-146
- Status last verified
- Jul 2008
- First submitted
- 7 Nov 2005
- Last updated
- 8 Jul 2008
- Results posted
- No
Publications
Nobre V, Harbarth S, Graf JD, Rohner P, Pugin J. Use of procalcitonin to shorten antibiotic treatment duration in septic patients: a randomized trial. Am J Respir Crit Care Med. 2008 Mar 1;177(5):498-505. doi: 10.1164/rccm.200708-1238OC. Epub 2007 Dec 20.
PubMed 18096708
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin-Guided Antimicrobial Discontinuation Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Sepsis
- ClinicalTrials.gov ID
- NCT00250666
- Acronym / sponsor ID
- HUG 05-146
- Conditions
- Sepsis
- Keywords
- Biological Markers, Procalcitonin, Critical Care, Diagnosis, Differential, Prospective Study, Sepsis, Antibiotic stewardship, Antimicrobial resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2007
- Study completion
- May 2007 (actual)
- First posted
- 8 Nov 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.
The current study aims to validate the diagnostic use of PCT assessing its capability to individualize and shorten the duration of antibiotic therapy in critically ill patients with suspected or confirmed sepsis.
In particular, no well-designed intervention study has properly examined the following hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic treatment duration in critically ill patients with suspected or documented sepsis, without harming patient safety.
Detailed description
Primary objective:
To assess the effect of repeated PCT measurements in critically ill patients with clinically suspected or microbiologically documented sepsis on duration of antimicrobial use and to compare this strategy to standard clinical practice, by using an improved PCT assay with a sensitivity of 0.06 ng/ml.
Secondary objectives:
To determine the impact of repeated PCT measurements on patient outcome (morbidity, mortality, emergence of antibiotic resistance and nosocomial super-infections).
Main measures:
Primary:
- Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure) Secondary:
- Cure and failure rate of infection (in N recurrent infections per 100 patients)
- 28-day case-fatality rate (in N deaths per 100 patients)
- Length of hospital stay (in days)
- Costs of antimicrobial therapy (in CHF)
- Rate of nosocomial super-infection (in N super-infections per 100 patients)
- Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-days)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with clinically suspected or microbiologically confirmed bacterial sepsis
- Informed consent
Key exclusion criteria (10 listed)
- Patients with microbiologically documented infections caused by the following microorganisms: Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis, Staphylococcus aureus
- Patients with fungal infections
- Patients with severe infections due to viruses or parasites (e.g. hemorrhagic fever, malaria)
- Patients with suspected or confirmed bacterial meningitis or endocarditis
- Patients with localized, deep-seated abscesses (e.g. brain abscess) without systemic sepsis
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 measurementPeripheral blood samples were collected in the morning, using vacuum tubes (BD Vacutainer SST II Plus plastic tubes; Becton Dickinson Diagnostic Systems, Allschwil, Switzerland). Circulating plasma PCT levels were measured with a time-resolved amplified cryptate emission technology assay (Kryptor PCT; Brahms AG, Hennigsdorf, Germany), with an assay sensitivity of 0.06 mg/L, approximately fourfold above mean normal levels. Measurements were performed 7 days a week. | Procedure or surgery | – |
Primary outcome
Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
6 secondary outcomes
Cure and failure rate of infection (in N recurrent infections per 100 patients)
28-day case-fatality rate (in N deaths per 100 patients)
Length of hospital stay (in days)
Costs of antimicrobial therapy (in CHF)
Rate of nosocomial super-infection (in N super-infections per 100 patients)
Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-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 8 Jul 2008.
- Derived from this study: PubMed 18096708Nobre V, Harbarth S, Graf JD, Rohner P, Pugin J. Use of procalcitonin to shorten antibiotic treatment duration in septic patients: a randomized trial. Am J Respir Crit Care Med. 2008 Mar 1;177(5):498-505. doi: 10.1164/rccm.200708-1238OC. Epub 2007 Dec 20.
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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.
Stephan J Harbarth, MD MS principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCT measurement in people with Sepsis, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 inclusion and 10 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 8 Jul 2008. 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 Switzerland. 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 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?
Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00250666, which also lists 1 linked publication.
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 8 Jul 2008.