Methicillin-Resistant Staphylococcus AureusNCT00457704
Carriage and Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA) in Patients Admitted to Home Care.
An observational study of Methicillin-Resistant Staphylococcus Aureus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Methicillin resistant Staphylococcus aureus (MRSA) which is one of the principal multidrug resistant organisms found in the hospitals all over the world, has recently emerged in the community. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- 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 to 90 years
- All sexes
- Adult, Older adult
Who may be able to join
- All adults patients positive to MRSA screening at admission in home care and coming from hospital facilities
- All patients MRSA negative leaving in the home of the positive patients
- Written informed consent
Who cannot join
- Patients admitted in home care for obstetrical or post-partum reasons
- Patients already in the study and being re-hospitalized and re-admitted in home care facilities.
Trial locations and contacts
1 site in 1 country.
France1 site
Dpt Immuno-Microbiologie des Pathologies Infectieuses - Hôpital Beaujon
Clichy, 92110
About this study
Methicillin resistant Staphylococcus aureus (MRSA) which is one of the principal multidrug resistant organisms found in the hospitals all over the world, has recently emerged in the community. However, for the moment (2002), the hospital remains the principal reservoir of MRSA so far and the patients discharged with a MRSA carriage can be the source of MRSA spreading in the community. In particular patients admitted to home care (HC) from acute care facilities represent a patient group with a high risk of MRSA carriage and of being the source of MRSA spreading in the community. The objective of this study is to determine whether HC patients are effectively a MRSA reservoir and a source for MRSA spreading in the community.
For that, from February 2003 to March 2004 any adult patient (except obstetric patient) (approximately 3360 patients for 16 HC settings), will be screened [nasal and skin lesion (if any) swabs] for MRSA carriage within the 48 h before his/her transfer. The patients found to be MRSA carriers will be visited by a physician who will ask patients as well as family members to participate in the study. Each patient and each family member who will have given agreement to participate, will be sampled (nasal swab for both patient and family members, and skin lesion swab for the patients with skin lesions) every month for 12 months by the nurse of the HC setting in which the patient will have been admitted. As soon as the patient will be discharged from HC setting and if the 12 month survey is not finished, patient and family member swab sampling will be performed by the nurse of the research team (NRT) every 3 months until the end of the survey period. These swabs will be transmitted by the NRT to the research center and analyze by the microbial technician of the research center. The bacteriological survey will be accompanied with an epidemiological survey in order to determine the risk factors for a long term MRSA carriage in the patients admitted in HC and also the risk factors for transmitting MRSA to their family.
This multi-centre and multi-investigator study will be performed over a period of 32 months (1 month to prepare the study, 13 months to screen patients with regard to MRSA carriage before their transfer from acute care settings into HC settings, 12 months to survey HC patients and their family members and 6 months to analyze data and prepare publications). Such a study will provide us with descriptive and quantitative data on MRSA strains introduced in the community by HC patients. From the analysis of risk factors of MRSA transmission from these patients to their family members, suggestions to limit this transmission might be drawn.
- Keywords
- MRSA, Home Care, Risk factors, transmissions, observational study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin-Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Marie-Hélène Nicolas-Chanoine, MD - PHD, Principal investigator, Assistance Publique des Hôpitaux de Paris - Hôpital Beaujon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457704
- Sponsor's protocol ID
- APHP-SARM-HAD-2003
- Status last verified
- Apr 2007
- First submitted
- 4 Apr 2007
- Last updated
- 6 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carriage and Transmission of Methicillin-Resistant Staphylococcus Aureus (MRSA) in Patients Admitted to Home Care.
- ClinicalTrials.gov ID
- NCT00457704
- Acronym / sponsor ID
- APHP-SARM-HAD-2003
- Keywords
- MRSA, Home Care, Risk factors, transmissions, observational study
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- First posted
- 6 Apr 2007 (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.
Methicillin resistant Staphylococcus aureus (MRSA) which is one of the principal multidrug resistant organisms found in the hospitals all over the world, has recently emerged in the community. However, for the moment (2002), the hospital remains the principal reservoir of MRSA so far and the patients discharged with a MRSA carriage can be the source of MRSA spreading in the community. In particular patients admitted to home care (HC) from acute care facilities represent a patient group with a high risk of MRSA carriage and of being the source of MRSA spreading in the community. The objective of this study is to determine whether HC patients are effectively a MRSA reservoir and a source for MRSA spreading in the community.
For that, from February 2003 to March 2004 any adult patient (except obstetric patient) (approximately 3360 patients for 16 HC settings), will be screened [nasal and skin lesion (if any) swabs] for MRSA carriage within the 48 h before his/her transfer. The patients found to be MRSA carriers will be visited by a physician who will ask patients as well as family members to participate in the study. Each patient and each family member who will have given agreement to participate, will be sampled (nasal swab for both patient and family members, and skin lesion swab for the patients with skin lesions) every month for 12 months by the nurse of the HC setting in which the patient will have been admitted. As soon as the patient will be discharged from HC setting and if the 12 month survey is not finished, patient and family member swab sampling will be performed by the nurse of the research team (NRT) every 3 months until the end of the survey period. These swabs will be transmitted by the NRT to the research center and analyze by the microbial technician of the research center. The bacteriological survey will be accompanied with an epidemiological survey in order to determine the risk factors for a long term MRSA carriage in the patients admitted in HC and also the risk factors for transmitting MRSA to their family.
This multi-centre and multi-investigator study will be performed over a period of 32 months (1 month to prepare the study, 13 months to screen patients with regard to MRSA carriage before their transfer from acute care settings into HC settings, 12 months to survey HC patients and their family members and 6 months to analyze data and prepare publications). Such a study will provide us with descriptive and quantitative data on MRSA strains introduced in the community by HC patients. From the analysis of risk factors of MRSA transmission from these patients to their family members, suggestions to limit this transmission might be drawn.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adults patients positive to MRSA screening at admission in home care and coming from hospital facilities
- All patients MRSA negative leaving in the home of the positive patients
- Written informed consent
Key exclusion criteria (2 listed)
- Patients admitted in home care for obstetrical or post-partum reasons
- Patients already in the study and being re-hospitalized and re-admitted in home care facilities.
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 was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2007.
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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.
Marie-Hélène Nicolas-Chanoine, MD - PHD principal investigator
Assistance Publique des Hôpitaux de Paris - Hôpital Beaujon
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 Methicillin-Resistant Staphylococcus Aureus, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 2 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 6 Apr 2007. 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 was stopped early. 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.
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 6 Apr 2007.