SepsisNCT00141973
Time Course of Procalcitonin and C Reactive Protein in Septic Patients Under Treatment With Corticosteroids
An observational study of Sepsis, run by Ospedale Regionale Bellinzona e Valli at 1 site in Switzerland.
Trial summary
A systemic treatment with corticosteroids has been advocated for various bacterial infectious diseases. Since the production of CRP is down-regulated by corticosteroids, a smaller increase or a more rapid decrease of this acute phase protein will: 1. suggest attenuated systemic inflammation, but 2. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Sepsis
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2004to Dec 2005
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute exacerbation of chronic obstructive pulmonary disease (COPD) due to bacterial pneumonia
Who cannot join
- Chronic systemic use of corticosteroids
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale Bellinzona e Valli
Bellinzona, Canton Ticino, 6500
About this study
A systemic treatment with corticosteroids has been advocated for various bacterial infectious diseases. Since the production of CRP is down-regulated by corticosteroids, a smaller increase or a more rapid decrease of this acute phase protein will:
- suggest attenuated systemic inflammation, but
- does not necessarily reflect adequate therapy of the infection.
For several reasons (good diagnostic tool for sepsis, induction not decreased by immunosuppressive therapy), procalcitonin could be a better marker for activity of sepsis in patients under corticosteroids. As this issue has not yet been examined the investigators will prospectively study the time-course of PTC and CRP in a well-defined septic patient group, that in adjunction to antibiotic therapy also received systemic corticosteroid treatment and compare it to a similar group without corticosteroid treatment.
- Conditions
- Sepsis
- Keywords
- Procalcitonin, Sepsis, Corticosteroids
- Medical subject headings
- Sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startNov 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale Bellinzona e Valli
- Sponsor type
- University, hospital or other
- Collaborators
- Brahms SA, D-16761 Hennigsdorf bei Berlin
- Investigators
- Andreas Perren, MD, Principal investigator, Ospedale Regionale Bellinzona e Valli, CH-6500 Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141973
- Sponsor's protocol ID
- CE1408
- Status last verified
- May 2008
- First submitted
- 1 Sep 2005
- Last updated
- 14 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course of Procalcitonin and C Reactive Protein in Septic Patients Under Treatment With Corticosteroids
- ClinicalTrials.gov ID
- NCT00141973
- Acronym / sponsor ID
- CE1408
- Conditions
- Sepsis
- Keywords
- Procalcitonin, Sepsis, Corticosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Ospedale Regionale Bellinzona e ValliUniversity, hospital or other
- Collaborators
- Brahms SA, D-16761 Hennigsdorf bei Berlin
- Study start
- Nov 2004
- Study completion
- Dec 2005
- First posted
- 2 Sep 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.
A systemic treatment with corticosteroids has been advocated for various bacterial infectious diseases. Since the production of CRP is down-regulated by corticosteroids, a smaller increase or a more rapid decrease of this acute phase protein will:
- suggest attenuated systemic inflammation, but
- does not necessarily reflect adequate therapy of the infection.
For several reasons (good diagnostic tool for sepsis, induction not decreased by immunosuppressive therapy), procalcitonin could be a better marker for activity of sepsis in patients under corticosteroids. As this issue has not yet been examined the investigators will prospectively study the time-course of PTC and CRP in a well-defined septic patient group, that in adjunction to antibiotic therapy also received systemic corticosteroid treatment and compare it to a similar group without corticosteroid treatment.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute exacerbation of chronic obstructive pulmonary disease (COPD) due to bacterial pneumonia
Key exclusion criteria (1 listed)
- Chronic systemic use of corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 May 2008.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
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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.
Andreas Perren, MD principal investigator
Ospedale Regionale Bellinzona e Valli, CH-6500 Bellinzona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Ospedale Regionale Bellinzona e Valli 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 1 inclusion and 1 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 14 May 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.
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.
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 14 May 2008.