Intensive Care Unit -Aquired Bloodstream Infections.BacterHyNCT02891902
Impact of Dedicated Hygienist Staff on the Occurrence of Intensive Care Unit -Aquired Bloodstream Infections
An observational study of Intensive Care Unit -Aquired Bloodstream Infections., run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The purpose of this study is to evaluate in a multicentric cluster randomized study the effect of the presence of dedicated nurses for training of ICU staff in preventing nosocomial infections. The rate of bloodstream infections per 100 admitted patients is used as the main endpoint. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intensive Care Unit -Aquired Bloodstream Infections.
- What is being tested?
- hygienist response
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Aug 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients admitted to reanimation department
Who may be able to join
- patients admitted to reanimation department
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Nord Assistance Publique Hôpitaux de Marseille
Marseille, 13015
About this study
The purpose of this study is to evaluate in a multicentric cluster randomized study the effect of the presence of dedicated nurses for training of ICU staff in preventing nosocomial infections. The rate of bloodstream infections per 100 admitted patients is used as the main endpoint. A sample of 4000 included patients in the 6 participating ICU is included with the objective to show a reduction of one third of the rate of ICU-acquired bloodstream infections. The study is currently at the end of the recrutimeent phase.
Read the detailed description
15% of patients admitted to intensive care have an infection acquired in the service, including bacteremia is a serious form. Compliance with hygiene measures and recommendations in the use of invasive devices can reduce the incidence. The advantage of simple recommendations type "bundle" could, however, be insufficient because not associated with training and monitoring compliance with the recommendations. The aim of this study is to show that the daily intervention of a public health nurse on the basis of a half full-time equivalent, allows these actions and therefore a reduction in the bloodstream of the attack rate acquired in the ICU compared dissemination of simple recommendations.
- Being tested
- hygienist response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hygienist responseOther
The daily presence of a public health nurse in the intensive care unit would implement such a strategy for prevention of infections and reduce the incidence of bloodstream infections acquired in intensive care.
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of first ICU acquired bloodstream infection for 100 admitted patients
Collection of blood cultures
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startOct 2013
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit -Aquired Bloodstream Infections.Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891902
- Sponsor's protocol ID
- RC12_3682
- Acronym
- BacterHy
- Status last verified
- Aug 2016
- First submitted
- 31 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dedicated Hygienist Staff on the Occurrence of Intensive Care Unit -Aquired Bloodstream Infections
- ClinicalTrials.gov ID
- NCT02891902
- Acronym / sponsor ID
- BacterHy / RC12_3682
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Sep 2016 (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 purpose of this study is to evaluate in a multicentric cluster randomized study the effect of the presence of dedicated nurses for training of ICU staff in preventing nosocomial infections. The rate of bloodstream infections per 100 admitted patients is used as the main endpoint. A sample of 4000 included patients in the 6 participating ICU is included with the objective to show a reduction of one third of the rate of ICU-acquired bloodstream infections. The study is currently at the end of the recrutimeent phase.
Detailed description
15% of patients admitted to intensive care have an infection acquired in the service, including bacteremia is a serious form. Compliance with hygiene measures and recommendations in the use of invasive devices can reduce the incidence. The advantage of simple recommendations type "bundle" could, however, be insufficient because not associated with training and monitoring compliance with the recommendations. The aim of this study is to show that the daily intervention of a public health nurse on the basis of a half full-time equivalent, allows these actions and therefore a reduction in the bloodstream of the attack rate acquired in the ICU compared dissemination of simple recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients admitted to reanimation department
Key inclusion criteria (1 listed)
- patients admitted to reanimation department
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| hygienist responseThe daily presence of a public health nurse in the intensive care unit would implement such a strategy for prevention of infections and reduce the incidence of bloodstream infections acquired in intensive care. | Other | – |
Primary outcome
rate of first ICU acquired bloodstream infection for 100 admitted patients
Time frame: 2 months
Collection of blood cultures
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 Sep 2016.
- Individual participant dataSharing planned: No
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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
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 Intensive Care Unit -Aquired Bloodstream Infections., run by Assistance Publique Hopitaux De Marseille at 1 site 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 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 8 Sep 2016. 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 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?
rate of first ICU acquired bloodstream infection for 100 admitted patients (time frame: 2 months). 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 8 Sep 2016.