ESBL InfectionMOSARNCT00773799
Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community
An observational study of ESBL Infection and Methicillin-Resistant Staphylococcus Aureus, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Data on occurrence of antimicrobial resistant bacteria acquisition in rehabilitation centers will be collected. After removal of patient identifiers, information regarding the patients population will be entered into electronic sheet. The phase will last twelve months in each center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESBL Infection, Methicillin-Resistant Staphylococcus Aureus
- How many people
- 1,200 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2008to Jan 2014
- 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: A rehabilitation center's department in which the hospitalized patients are older then 18 years old.
Who may be able to join
- Hospitalized patients are older then 18 years old
Who cannot join
- Age 18 years or less
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tasmc
Tel Aviv, 64239
Yaffa lerman, md, 97252-4266910, yaffale@tasmc.health.gov.il
About this study
Data on occurrence of antimicrobial resistant bacteria acquisition in rehabilitation centers will be collected. After removal of patient identifiers, information regarding the patients population will be entered into electronic sheet. The phase will last twelve months in each center.
Read the detailed description
All patients admitted to the department will be examined on admission, two weeks latter and monthly by obtaining nares and perirectal cultures. These cultures will be processed for detection the target organisms. This activity is part of the good medical practice and is performed on routine basis in various hospital units
Epidemiological data will be collected from patient records. This data will be stored after removal of all patients' identifiers. These data will be transferred for analysis to Tel Aviv Medical Center
- Keywords
- To define activities and patient characteristics likely to lead to dissemination of resistant bacteria in rehabilitation centers and, To define specific risk factors for acquisition of resistant bacteria (ESBL producers and MRSA) in rehabilitation centers., ESBL producers, MRSA
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 |
|---|---|---|
| rehabilitation center's hospitalized patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
A rehabilitation center's department in which the hospitalized patients are older then 18 years old.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ESBL InfectionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Yehuda carmeli, MD MPH, Principal investigator, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773799
- Sponsor's protocol ID
- TASMC-08-YC-239-CTIL
- Acronym
- MOSAR
- Status last verified
- Oct 2008
- First submitted
- 6 Oct 2008
- Last updated
- 16 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Vovko P, Retelj M, Cretnik TZ, Jutersek B, Harlander T, Kolman J, Gubina M. Risk factors for colonization with methicillin-resistant Staphylococcus aureus in a long-term-care facility in Slovenia. Infect Control Hosp Epidemiol. 2005 Feb;26(2):191-5. doi: 10.1086/502525.
PubMed 15756891Lucet JC, Grenet K, Armand-Lefevre L, Harnal M, Bouvet E, Regnier B, Andremont A. High prevalence of carriage of methicillin-resistant Staphylococcus aureus at hospital admission in elderly patients: implications for infection control strategies. Infect Control Hosp Epidemiol. 2005 Feb;26(2):121-6. doi: 10.1086/502514.
PubMed 15756880Ben-Ami R, Schwaber MJ, Navon-Venezia S, Schwartz D, Giladi M, Chmelnitsky I, Leavitt A, Carmeli Y. Influx of extended-spectrum beta-lactamase-producing enterobacteriaceae into the hospital. Clin Infect Dis. 2006 Apr 1;42(7):925-34. doi: 10.1086/500936. Epub 2006 Feb 27.
PubMed 16511754Stelfox HT, Bates DW, Redelmeier DA. Safety of patients isolated for infection control. JAMA. 2003 Oct 8;290(14):1899-905. doi: 10.1001/jama.290.14.1899.
PubMed 14532319Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000 Sep 16;321(7262):694-6. doi: 10.1136/bmj.321.7262.694. No abstract available.
PubMed 10987780Pope C, van Royen P, Baker R. Qualitative methods in research on healthcare quality. Qual Saf Health Care. 2002 Jun;11(2):148-52. doi: 10.1136/qhc.11.2.148.
PubMed 12448807Bartholomew LK, Parcel GS, Kok G. Intervention mapping: a process for developing theory- and evidence-based health education programs. Health Educ Behav. 1998 Oct;25(5):545-63. doi: 10.1177/109019819802500502.
PubMed 9768376van Bokhoven MA, Kok G, van der Weijden T. Designing a quality improvement intervention: a systematic approach. Qual Saf Health Care. 2003 Jun;12(3):215-20. doi: 10.1136/qhc.12.3.215.
PubMed 12792013Smith DL, Dushoff J, Perencevich EN, Harris AD, Levin SA. Persistent colonization and the spread of antibiotic resistance in nosocomial pathogens: resistance is a regional problem. Proc Natl Acad Sci U S A. 2004 Mar 9;101(10):3709-14. doi: 10.1073/pnas.0400456101. Epub 2004 Feb 25.
PubMed 14985511
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community
- ClinicalTrials.gov ID
- NCT00773799
- Acronym / sponsor ID
- MOSAR / TASMC-08-YC-239-CTIL
- Keywords
- To define activities and patient characteristics likely to lead to dissemination of resistant bacteria in rehabilitation centers and, To define specific risk factors for acquisition of resistant bacteria (ESBL producers and MRSA) in rehabilitation centers., ESBL producers, MRSA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 16 Oct 2008 (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.
Data on occurrence of antimicrobial resistant bacteria acquisition in rehabilitation centers will be collected. After removal of patient identifiers, information regarding the patients population will be entered into electronic sheet. The phase will last twelve months in each center.
Detailed description
All patients admitted to the department will be examined on admission, two weeks latter and monthly by obtaining nares and perirectal cultures. These cultures will be processed for detection the target organisms. This activity is part of the good medical practice and is performed on routine basis in various hospital units
Epidemiological data will be collected from patient records. This data will be stored after removal of all patients' identifiers. These data will be transferred for analysis to Tel Aviv Medical Center
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rehabilitation center's hospitalized patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A rehabilitation center's department in which the hospitalized patients are older then 18 years old.
Key inclusion criteria (1 listed)
- Hospitalized patients are older then 18 years old
Key exclusion criteria (1 listed)
- Age 18 years or less
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
A rehabilitation center's department in which the hospitalized patients are older then 18 years old.
Time frame: 1 YEAR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2008.
- Background: PubMed 15756891Vovko P, Retelj M, Cretnik TZ, Jutersek B, Harlander T, Kolman J, Gubina M. Risk factors for colonization with methicillin-resistant Staphylococcus aureus in a long-term-care facility in Slovenia. Infect Control Hosp Epidemiol. 2005 Feb;26(2):191-5. doi: 10.1086/502525.
- Background: PubMed 15756880Lucet JC, Grenet K, Armand-Lefevre L, Harnal M, Bouvet E, Regnier B, Andremont A. High prevalence of carriage of methicillin-resistant Staphylococcus aureus at hospital admission in elderly patients: implications for infection control strategies. Infect Control Hosp Epidemiol. 2005 Feb;26(2):121-6. doi: 10.1086/502514.
- Background: PubMed 16511754Ben-Ami R, Schwaber MJ, Navon-Venezia S, Schwartz D, Giladi M, Chmelnitsky I, Leavitt A, Carmeli Y. Influx of extended-spectrum beta-lactamase-producing enterobacteriaceae into the hospital. Clin Infect Dis. 2006 Apr 1;42(7):925-34. doi: 10.1086/500936. Epub 2006 Feb 27.
- Background: PubMed 14532319Stelfox HT, Bates DW, Redelmeier DA. Safety of patients isolated for infection control. JAMA. 2003 Oct 8;290(14):1899-905. doi: 10.1001/jama.290.14.1899.
- Background: PubMed 10987780Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000 Sep 16;321(7262):694-6. doi: 10.1136/bmj.321.7262.694. No abstract available.
- Background: PubMed 12448807Pope C, van Royen P, Baker R. Qualitative methods in research on healthcare quality. Qual Saf Health Care. 2002 Jun;11(2):148-52. doi: 10.1136/qhc.11.2.148.
- Background: PubMed 9768376Bartholomew LK, Parcel GS, Kok G. Intervention mapping: a process for developing theory- and evidence-based health education programs. Health Educ Behav. 1998 Oct;25(5):545-63. doi: 10.1177/109019819802500502.
- Background: PubMed 12792013van Bokhoven MA, Kok G, van der Weijden T. Designing a quality improvement intervention: a systematic approach. Qual Saf Health Care. 2003 Jun;12(3):215-20. doi: 10.1136/qhc.12.3.215.
- Background: PubMed 14985511Smith DL, Dushoff J, Perencevich EN, Harris AD, Levin SA. Persistent colonization and the spread of antibiotic resistance in nosocomial pathogens: resistance is a regional problem. Proc Natl Acad Sci U S A. 2004 Mar 9;101(10):3709-14. doi: 10.1073/pnas.0400456101. Epub 2004 Feb 25.
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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.
Yehuda carmeli, MD MPH principal investigator
TASMC
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 ESBL Infection and Methicillin-Resistant Staphylococcus Aureus, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 16 Oct 2008. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yaffa lerman, MD (97252-4266910, yaffale@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A rehabilitation center's department in which the hospitalized patients are older then 18 years old. (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00773799, which also lists 9 linked publications.
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 16 Oct 2008.