Hemodialysis PatientsPhase 4CIBERSTAPHNCT02945722
Study of the Impact of a Targeted Decolonization of S. Aureus Persistent Carriers
A Phase 4 study testing Decolonization and No decolonization in people with Hemodialysis Patients, run by Centre Hospitalier Universitaire de Saint Etienne at 9 sites in France.
Trial summary
S. aureus nasal carriage is a well-known risk factor for S. aureus infections in hemodialysis (HD) patients. Strains of carriage and infections are the same in >80% of cases We recently shown that persistent carriers of S. aureus, not intermittent ones are at increased risk of staphylococcal infections in HD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- Decolonization and No decolonization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 434 participants
- Where
- 9 sitesFrance
- Study dates
- 23 Feb 2018to 26 Oct 2024
- 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
- Adults (age ≥ 18 years-old)
- Patient under chronic hemodialysis
- Patent that accepted to participate in the study with a written consent form signed
Who cannot join
- Patients under peritoneal dialysis
- Patients with an active infection at the time of inclusion
- Patients previously treated by mupirocin and chlorhexidine for decolonization purpose
- Patients that received antimicrobials active on S. aureus during the month before the inclusion
- Patients with allergy to mupirocin or chlorhexidine
- Patients treated by hemodialysis transiently (non-terminal kidney failure)
- Pregnancy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CH d'Annecy-Genevois
Annecy
CH Emile Roux
Le Puy-en-Velay
Aural
Lyon
CH St-Joseph St-Luc
Lyon
AIDER Santé
Montpellier
ARTIC42
Saint-Etienne
Chu Saint-Etienne
Saint-Etienne
NephroCare
Sainte-Foy-lès-Lyon
CH Yssingeaux - Hôpital Local
Yssingeaux
About this study
Official title: Study of the Impact of a Targeted Decolonization of S. Aureus Persistent Carriers on the Occurrence of S. Aureus Infections in Hemodialysis Patients
- aureus nasal carriage is a well-known risk factor for S. aureus infections in hemodialysis (HD) patients. Strains of carriage and infections are the same in >80% of cases We recently shown that persistent carriers of S. aureus, not intermittent ones are at increased risk of staphylococcal infections in HD. Thanks to a new algorithm developped based on one nasal sample the determination of carriage status (persistent, intermittent or non-carriers) among patients is easy. Mupirocin use in HD have been shown to reduce significantly S. aureus infections however, multiples schedules of decolonization have been proposed to all S. aureus carriers. To date, there is no national guideline for decolonization of S. aureus in HD. We showed that only 50% of HD centers in France propose screening and decolonization of S. aureus carriers. The aim of the study is therefore to evaluate the impact of a targeted decolonization of S. aureus persistent carriers using mupirocin nasal ointment and chlorhexidine baths during 5 days on the occurrence of S. aureus infections in HD patients compared to the absence of decolonization using a randomized open study methodology.
Read the detailed description
Hemodialysis patients will be randomized in 2 arms: one arm where persistent carriers will be decolonized. Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. Screening of persistent carriers in this arm will be done every 3 months and a new decolonization will be proposed to patients found (again) persistent carriers. Determination of carriage status will be done using one nasal swab by following the algorithm previously described. Bacterial load will be determined by a quantitative S. aureus PCR (Polymerase Chain Reaction) : persistent carriers are the patient with a bacterial load > 103 CFU/mL (Colony Forming Unit) .
The other arm is HD patients in which decolonization is not performed including impersistent carriers.
All infections that occurred in enrolled patients will be counted in both groups
- Conditions
- Hemodialysis Patients
- Being tested
- Decolonization, No decolonization
- Keywords
- Hemodialysis, S. Aureus, Decolonization, Persistent carriage
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecolonizationDrug
Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. Screening of persistent carriers will be done every 3 months
No decolonizationOther
Screening of persistent carriers in this arm will be done every 3 months
| Study group | Role | What they receive |
|---|---|---|
| Decolonization | Active comparator | persistent carriers will be decolonized. Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. Receives: Drug: Decolonization |
| No decolonization | Placebo comparator | HD patients in which decolonization is not performed including impersistent carriers. Receives: Other: No decolonization |
What is being measured
The primary outcome is the main question the study is designed to answer.
S. aureus infection
Number of S. Aureus define by Centers for Disease Control
Measured: 12 months
Secondary outcomes (7)
endogenous S. aureus infections
same strain of carriage and infection
Measured: 12 months
Bacteremias S. aureus
Impact of Bacteremias S. aureus
Measured: 12 months
strain of S. aureus
Percentage of resistants strains of S. aureus at mupirocin and chlorhexidine
Measured: 12 months
persistents carriers of S. aureus
Percentage of persistents carriers of S. aureus
Measured: Months : 3, 6, 9, 12
intermittents carriers of S. aureus
Percentage of intermittents carriers of S. aureus
Measured: Months : 3, 6, 9, 12
non-carriers carriers of S. aureus
Percentage of non-carriers carriers of S. aureus
Measured: Months : 3, 6, 9, 12
other bacterial infections
Impact of other bacterial infections without S. aureus
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start23 Feb 2018
- Primary completion26 Oct 2024
- Study completion26 Oct 2024
Why it stopped: Lack of inclusons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Elisabeth Botelho-Nevers, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945722
- Sponsor's protocol ID
- 1608170
- Other IDs
- 2016-004381-25, 2016
- Acronym
- CIBERSTAPH
- Status last verified
- Dec 2024
- First submitted
- 25 Oct 2016
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of a Targeted Decolonization of S. Aureus Persistent Carriers on the Occurrence of S. Aureus Infections in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02945722
- Acronym / sponsor ID
- CIBERSTAPH / 1608170
- Conditions
- Hemodialysis Patients
- Keywords
- Hemodialysis, S. Aureus, Decolonization, Persistent carriage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusons
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 26 Oct 2024 (actual)
- Study completion
- 26 Oct 2024 (actual)
- First posted
- 26 Oct 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.
- aureus nasal carriage is a well-known risk factor for S. aureus infections in hemodialysis (HD) patients. Strains of carriage and infections are the same in >80% of cases We recently shown that persistent carriers of S. aureus, not intermittent ones are at increased risk of staphylococcal infections in HD. Thanks to a new algorithm developped based on one nasal sample the determination of carriage status (persistent, intermittent or non-carriers) among patients is easy. Mupirocin use in HD have been shown to reduce significantly S. aureus infections however, multiples schedules of decolonization have been proposed to all S. aureus carriers. To date, there is no national guideline for decolonization of S. aureus in HD. We showed that only 50% of HD centers in France propose screening and decolonization of S. aureus carriers. The aim of the study is therefore to evaluate the impact of a targeted decolonization of S. aureus persistent carriers using mupirocin nasal ointment and chlorhexidine baths during 5 days on the occurrence of S. aureus infections in HD patients compared to the absence of decolonization using a randomized open study methodology.
Detailed description
Hemodialysis patients will be randomized in 2 arms: one arm where persistent carriers will be decolonized. Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. Screening of persistent carriers in this arm will be done every 3 months and a new decolonization will be proposed to patients found (again) persistent carriers. Determination of carriage status will be done using one nasal swab by following the algorithm previously described. Bacterial load will be determined by a quantitative S. aureus PCR (Polymerase Chain Reaction) : persistent carriers are the patient with a bacterial load > 103 CFU/mL (Colony Forming Unit) .
The other arm is HD patients in which decolonization is not performed including impersistent carriers.
All infections that occurred in enrolled patients will be counted in both groups
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decolonization | Active comparator | Drug: Decolonizationpersistent carriers will be decolonized. Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. |
| No decolonization | Placebo comparator | Other: No decolonizationHD patients in which decolonization is not performed including impersistent carriers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (age ≥ 18 years-old)
- Patient under chronic hemodialysis
- Patent that accepted to participate in the study with a written consent form signed
Key exclusion criteria (7 listed)
- Patients under peritoneal dialysis
- Patients with an active infection at the time of inclusion
- Patients previously treated by mupirocin and chlorhexidine for decolonization purpose
- Patients that received antimicrobials active on S. aureus during the month before the inclusion
- Patients with allergy to mupirocin or chlorhexidine
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 |
|---|---|---|
| DecolonizationDecolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. Screening of persistent carriers will be done every 3 months | Drug | Decolonization |
| No decolonizationScreening of persistent carriers in this arm will be done every 3 months | Other | No decolonization |
Primary outcome
S. aureus infection
Time frame: 12 months
Number of S. Aureus define by Centers for Disease Control
7 secondary outcomes
endogenous S. aureus infections
Time frame: 12 months
Bacteremias S. aureus
Time frame: 12 months
strain of S. aureus
Time frame: 12 months
persistents carriers of S. aureus
Time frame: Months : 3, 6, 9, 12
intermittents carriers of S. aureus
Time frame: Months : 3, 6, 9, 12
non-carriers carriers of S. aureus
Time frame: Months : 3, 6, 9, 12
other bacterial infections
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Lack of inclusons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Elisabeth Botelho-Nevers, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Decolonization and No decolonization in people with Hemodialysis Patients, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Dec 2024. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Lack of inclusons). Results are not available in the source record.
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?
S. aureus infection (time frame: 12 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 18 Dec 2024.