Staphylococcus AureusDigeSTAPHNCT02547272
Epidemiological Study of Intestinal Colonization With Staphylococcus Aureus
An observational study of Staphylococcus Aureus, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Nasal colonization with S. aureus is a risk factor for infection with this bacterium. A methodologically well conducted study of S. aureus bacteremia showed that 80% of S. aureus bacteremia with are due to the strain isolated in the nasal level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- Nasal and rectal bacterial samples
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Jul 2013
- 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: Patients hospitalized in intensive care
Who may be able to join
- patients hospitalized in intensive care and benefiting from a screening multiresistant bacteria in nasal and rectal level under routine care
Who cannot join
- refusal of the patient's family
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Study of Intestinal Colonization With Staphylococcus Aureus in a Cohort of Adult Patients Hospitalized in Intensive Care at the University Hospital of St Etienne.
Nasal colonization with S. aureus is a risk factor for infection with this bacterium. A methodologically well conducted study of S. aureus bacteremia showed that 80% of S. aureus bacteremia with are due to the strain isolated in the nasal level. However, as part of a study coordinated by the CHU of Saint-Etienne, less than 50% of infections in prosthetic orthopedic devices have been linked to nasal carriage . Outside of exogenous infections, intestinal colonization with S. aureus could be an alternative source of endogenous infections with the waning of orthopedic surgery. In the general population, considering that about one third of the subjects were colonized with S. aureus nasal level and 1 in 5 in the intestine However the proportion of exclusive intestinal porting is not well known .
This study will analyze, among ICU patients, porting S. aureus nasal and rectal level. It will better clarify the relationship between nasal and rectal ports and the risk of developing an infection.
Read the detailed description
The adult patients hospitalized in intensive care at the University Hospital of Saint-Etienne have a multiresistant bacteria porting screening at the nose and rectum at admission and then once a week. These samples will be carried unchanged way for the study but will also be a research S Aureus
- Conditions
- Staphylococcus Aureus
- Being tested
- Nasal and rectal bacterial samples
- Keywords
- Intensive care, S Aureus
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal and rectal bacterial samplesProcedure or surgery
Bacterial nasal and rectal samples at admission and one weekly for the presence of S Aureus
| Study group | Role | What they receive |
|---|---|---|
| Nasal and rectal samples | ICU patients with nasal and rectal bacterial samples for the presence of S Aureus Receives: Procedure: Nasal and rectal bacterial samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of S. aureus colonization at rectal level
The presence of a colony of S. aureus on one of the samples
Measured: 1 month
Secondary outcomes (1)
S. aureus strains similar to nasal and rectal level
- aureus strains similar in molecular typing
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe BERTHELOT, Md-PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547272
- Sponsor's protocol ID
- 1208087
- Other IDs
- 2012-A01182-41
- Acronym
- DigeSTAPH
- Status last verified
- Mar 2016
- First submitted
- 9 Sep 2015
- Last updated
- 23 Mar 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 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Intestinal Colonization With Staphylococcus Aureus in a Cohort of Adult Patients Hospitalized in Intensive Care at the University Hospital of St Etienne.
- ClinicalTrials.gov ID
- NCT02547272
- Acronym / sponsor ID
- DigeSTAPH / 1208087
- Conditions
- Staphylococcus Aureus
- Keywords
- Intensive care, S Aureus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Sep 2015 (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.
Nasal colonization with S. aureus is a risk factor for infection with this bacterium. A methodologically well conducted study of S. aureus bacteremia showed that 80% of S. aureus bacteremia with are due to the strain isolated in the nasal level. However, as part of a study coordinated by the CHU of Saint-Etienne, less than 50% of infections in prosthetic orthopedic devices have been linked to nasal carriage . Outside of exogenous infections, intestinal colonization with S. aureus could be an alternative source of endogenous infections with the waning of orthopedic surgery. In the general population, considering that about one third of the subjects were colonized with S. aureus nasal level and 1 in 5 in the intestine However the proportion of exclusive intestinal porting is not well known .
This study will analyze, among ICU patients, porting S. aureus nasal and rectal level. It will better clarify the relationship between nasal and rectal ports and the risk of developing an infection.
Detailed description
The adult patients hospitalized in intensive care at the University Hospital of Saint-Etienne have a multiresistant bacteria porting screening at the nose and rectum at admission and then once a week. These samples will be carried unchanged way for the study but will also be a research S Aureus
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal and rectal samples | – | Procedure: Nasal and rectal bacterial samplesICU patients with nasal and rectal bacterial samples for the presence of S Aureus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in intensive care
Key inclusion criteria (1 listed)
- patients hospitalized in intensive care and benefiting from a screening multiresistant bacteria in nasal and rectal level under routine care
Key exclusion criteria (1 listed)
- refusal of the patient's family
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 |
|---|---|---|
| Nasal and rectal bacterial samplesBacterial nasal and rectal samples at admission and one weekly for the presence of S Aureus | Procedure or surgery | Nasal and rectal samples |
Primary outcome
prevalence of S. aureus colonization at rectal level
Time frame: 1 month
The presence of a colony of S. aureus on one of the samples
1 secondary outcome
S. aureus strains similar to nasal and rectal level
Time frame: 1 month
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 23 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Staphylococcus Aureus
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin Resistance in Staphylococcus Aureus (MRSA)
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
RecruitingPhase 3
Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
Infective Endocarditis
Active, not recruitingPhase 1
A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults
Staphylococcus Aureus Bloodstream Infection
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.
Philippe BERTHELOT, Md-PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Staphylococcus Aureus, run by Centre Hospitalier Universitaire de Saint Etienne 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 23 Mar 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?
prevalence of S. aureus colonization at rectal level (time frame: 1 month). 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 23 Mar 2016.