Community-Acquired InfectionsNCT01606631
Role of Beta-blockers in the Prevention on the Arisen of a Severe Sepsis (TESS)
An observational study of Community-Acquired Infections, run by Rennes University Hospital at 9 sites in France.
Trial summary
The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of infectious diseases. They are one of the top ten causes of death in industrialized countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-Acquired Infections
- How many people
- 2,444 participants
- Where
- 9 sitesFrance
- Study dates
- Sep 2009to Feb 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Case : patients included in the study and admitted to the ICU either directly from UAA or after a hospitalization in a specialty, for a severe sepsis or septic shock on their infectious disease community. Control : patients included in the study with an infectious disease community, admitted to a specialty, and have not progressed to severe sepsis or septic shock before hospital discharge.
Who may be able to join
- Common characteristics of cases and controls:
- Patients aged of more than 18 years old
- Hospitalized patients, during the period of study, via the ICU of the participating hospital center, for a community infectious pathology:
- lower respiratory infections (pneumonia)
- intra-abdominal infections (cholangitis, diverticulitis, peritonitis)
- urinary parenchymal infection (pyelonephritis complicated or without abscess, prostatitis, orchitis, epididymitis)
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- infections of skin and soft tissue infections (cellulitis, fasciitis)
- meningitis, endocarditis, osteo-articular infections, salpingitis
- Definition of cases:
- Patient included in the study and admitted to the emergency service either directly from ICU or after a hospitalization in a specialty for severe sepsis or septic shock on their infectious disease community.
- Definition of controls:
- Patient included in the study with an infectious disease community, admitted to a specialty, and have not progressed to severe sepsis or septic shock before being released from the hospital.
- Non inclusion Criteria:
- Opposition of the patient to the IT processing of its data within the framework of this observational study.
- Exclusion criteria: Occurrence, during hospitalization, a severe sepsis or septic shock associated with a nosocomial superinfection.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Brest University Hospital
Brest, 29200
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63003
Groupe hospitalier Raymond Poincaré, AP-HP
Garches, 92380
Grenoble University Hospital (A. Michallon)
Grenoble, 38048
Limoges University Hospital (Hospital Dupuytren)
Limoges, 87042
Nancy University Hospital (Jeanne d'Arc)
Nancy, 54201
Rennes University Hospital (Pontchaillou)
Rennes, Ille-et-Vilaine, 35000
Saint Etienne University Hospital (Bellevue)
Saint-Etienne, 42055
Tours University Hospital (Bretonneau)
Tours, 37044
About this study
Official title: Evaluation of the Protective Role of Beta-blockers Prescribed in a Chronic Way on the Arisen of a Severe Septic Syndrome or a Toxic Shock at Patients Having a Community Infection
The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of infectious diseases. They are one of the top ten causes of death in industrialized countries. But an eventual protective role of beta-blockers (anti-hypertensive drug) in their occurrence on a community infection has never been studied. The objective of this study is to evaluate this role.
Read the detailed description
The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of infectious diseases. They are one of the top ten causes of death in industrialized countries. The adrenergic system is heavily involved in this pathological/physiological context. If the effect of various therapeutic strategies allowing the care of the SS/TS was widely estimated, the impact, positive or negative, therapeutic prescribed in the long term or more punctually - but be that as it may before the arisen of the sepsis - on the evolution of a community acute infectious pathology towards the SS/TS, had only little studied.
The main objective of this study is to estimate the possible protective role of a long-term prescription of a beta-blocker on the arisen of the SS/TS in patients having an acute infectious pathology of community origin.
The secondary objective will be to estimate, at the patients having developed a SS/TS, the impact of this long-term prescription of beta-blockers on the mortality in intensive care unit (ICU).
- Conditions
- Community-Acquired Infections
- Keywords
- severe sepsis, toxic shock
- Medical subject headings
- Community-Acquired Infections, Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 : experimental (case) | Patients included in the study and admitted to the ICU either directly from UAA or after a hospitalization in a specialty, for a severe sepsis or septic shock on their infectious disease community. | |
| Arm 2 : control | Patients included in the study with an infectious disease community, admitted to a specialty, and have not progressed to severe sepsis or septic shock before hospital discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the occurrence of severe sepsis, moving toward or away from septic shock.
From the date of randomization until the date of first documented assessed severe sepsis (moving toward or away from septic shock) up to the end of hospitalisation.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startSep 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Acquired InfectionsStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bellissant Eric, MD, PhD, Study director, Rennes University Hospital - CIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606631
- Sponsor's protocol ID
- CNIL AR091723
- Status last verified
- Apr 2012
- First submitted
- 24 Feb 2012
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Protective Role of Beta-blockers Prescribed in a Chronic Way on the Arisen of a Severe Septic Syndrome or a Toxic Shock at Patients Having a Community Infection
- ClinicalTrials.gov ID
- NCT01606631
- Acronym / sponsor ID
- CNIL AR091723
- Conditions
- Community-Acquired Infections
- Keywords
- severe sepsis, toxic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,444 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 28 May 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.
The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of infectious diseases. They are one of the top ten causes of death in industrialized countries. But an eventual protective role of beta-blockers (anti-hypertensive drug) in their occurrence on a community infection has never been studied. The objective of this study is to evaluate this role.
Detailed description
The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of infectious diseases. They are one of the top ten causes of death in industrialized countries. The adrenergic system is heavily involved in this pathological/physiological context. If the effect of various therapeutic strategies allowing the care of the SS/TS was widely estimated, the impact, positive or negative, therapeutic prescribed in the long term or more punctually - but be that as it may before the arisen of the sepsis - on the evolution of a community acute infectious pathology towards the SS/TS, had only little studied.
The main objective of this study is to estimate the possible protective role of a long-term prescription of a beta-blocker on the arisen of the SS/TS in patients having an acute infectious pathology of community origin.
The secondary objective will be to estimate, at the patients having developed a SS/TS, the impact of this long-term prescription of beta-blockers on the mortality in intensive care unit (ICU).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : experimental (case) | – | –Patients included in the study and admitted to the ICU either directly from UAA or after a hospitalization in a specialty, for a severe sepsis or septic shock on their infectious disease community. |
| Arm 2 : control | – | –Patients included in the study with an infectious disease community, admitted to a specialty, and have not progressed to severe sepsis or septic shock before hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Case : patients included in the study and admitted to the ICU either directly from UAA or after a hospitalization in a specialty, for a severe sepsis or septic shock on their infectious disease community. Control : patients included in the study with an infectious disease community, admitted to a specialty, and have not progressed to severe sepsis or septic shock before hospital discharge.
Key inclusion criteria (15 listed)
- Common characteristics of cases and controls:
- Patients aged of more than 18 years old
- Hospitalized patients, during the period of study, via the ICU of the participating hospital center, for a community infectious pathology:
- Patient included in the study and admitted to the emergency service either directly from ICU or after a hospitalization in a specialty for severe sepsis or septic shock on their infectious disease community.
- Patient included in the study with an infectious disease community, admitted to a specialty, and have not progressed to severe sepsis or septic shock before being released from the hospital.
Key exclusion criteria (0 listed)
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
The primary outcome is the occurrence of severe sepsis, moving toward or away from septic shock.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
From the date of randomization until the date of first documented assessed severe sepsis (moving toward or away from septic shock) up to the end of hospitalisation.
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 28 May 2012.
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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.
Bellissant Eric, MD, PhD study director
Rennes University Hospital - CIC
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-Acquired Infections, run by Rennes University Hospital 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 15 inclusion and 0 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 28 May 2012. 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.
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?
The primary outcome is the occurrence of severe sepsis, moving toward or away from septic shock. (time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks). 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 28 May 2012.