MRSA InfectionNCT00766259
Relationship of Staphylococcal Colonization to Infection
An observational study of MRSA Infection, run by Veterans BioMedical Research Institute.
Trial summary
Inpatients will be prospectively have nares screened and MRSA strains collected. All clinical MRSA strains of patients will also be prospectively collected. A sensitive strain discrimination test of spa typing will be used to determine if the strains are related. Hypotheses are 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- MRSA Infection
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jun 2012
- 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: all patients admited
Who may be able to join
- Admitted and one of the co-morbid groups
- Ambulatory care patient with no infections
Who cannot join
- All others
About this study
Inpatients will be prospectively have nares screened and MRSA strains collected. All clinical MRSA strains of patients will also be prospectively collected. A sensitive strain discrimination test of spa typing will be used to determine if the strains are related. Hypotheses are
- Strain colonization durations vary and may be very short in days to weeks.
- Colonizing strains rarely infect 3) Both 1 and 2 may be affected by the patient's co-morbidity.
Read the detailed description
Patients of special interest:
- Skin and soft tissue infection
- Nursing home patients
- Vascular patients with leg lesions
- ICU patients
- Hemodialysis patients
- Outpatients without history of infections(controls) will have nares screened for MRSA and then monthly for 1 year.
All strains will be saved and spa typed. Analysis of the data will be performed to answer the questions and hypotheses and to answer is the screening effort and the isolation of patients for MRSA as is in current practice worthwhile and is there any scientific data to support this practice
- Conditions
- MRSA Infection
- Keywords
- methicillin-resistant Staphylococcus, colonization
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 |
|---|---|---|
| 1 | Hemodialysis | |
| 2 | Intensive care | |
| 3 | vascular patients with open wounds | |
| 4 | nursing home | |
| 5 | skin infections | |
| 6 | control- ambulatory care clinic patients with no infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of infection strains which were also colonizer earlier
Measured: 3 years
Secondary outcomes (1)
Duration of strain colonization among co-morbidity cohorts
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startJul 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2012 (estimated)
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSA InfectionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans BioMedical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766259
- Sponsor's protocol ID
- Eng-MRSA
- Status last verified
- Mar 2021
- First submitted
- 2 Oct 2008
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Staphylococcal Colonization to Infection
- ClinicalTrials.gov ID
- NCT00766259
- Acronym / sponsor ID
- Eng-MRSA
- Conditions
- MRSA Infection
- Keywords
- methicillin-resistant Staphylococcus, colonization
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Veterans BioMedical Research InstituteUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 3 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.
Inpatients will be prospectively have nares screened and MRSA strains collected. All clinical MRSA strains of patients will also be prospectively collected. A sensitive strain discrimination test of spa typing will be used to determine if the strains are related. Hypotheses are
- Strain colonization durations vary and may be very short in days to weeks.
- Colonizing strains rarely infect 3) Both 1 and 2 may be affected by the patient's co-morbidity.
Detailed description
Patients of special interest:
- Skin and soft tissue infection
- Nursing home patients
- Vascular patients with leg lesions
- ICU patients
- Hemodialysis patients
- Outpatients without history of infections(controls) will have nares screened for MRSA and then monthly for 1 year.
All strains will be saved and spa typed. Analysis of the data will be performed to answer the questions and hypotheses and to answer is the screening effort and the isolation of patients for MRSA as is in current practice worthwhile and is there any scientific data to support this practice
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Hemodialysis |
| 2 | – | –Intensive care |
| 3 | – | –vascular patients with open wounds |
| 4 | – | –nursing home |
| 5 | – | –skin infections |
| 6 | – | –control- ambulatory care clinic patients with no infections |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients admited
Key inclusion criteria (2 listed)
- Admitted and one of the co-morbid groups
- Ambulatory care patient with no infections
Key exclusion criteria (1 listed)
- All others
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
Percent of infection strains which were also colonizer earlier
Time frame: 3 years
1 secondary outcome
Duration of strain colonization among co-morbidity cohorts
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of MRSA Infection, run by Veterans BioMedical Research Institute.
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 2 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: withdrawn, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Percent of infection strains which were also colonizer earlier (time frame: 3 years). 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 3 May 2024.