Methicillin-Resistant Staphylococcus AureusSJMRSANCT00713674
Comparison of Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) Using Theraworx
A study testing Theraworx and mupirocin antibiotic ointment in people with Methicillin-Resistant Staphylococcus Aureus, run by Mercy Research.
Trial summary
The purpose of this study is to examine treatment method of Methicillin-resistant Staphylococcus aureus (MRSA) decolonization in patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus
- What is being tested?
- Theraworx and mupirocin antibiotic ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Feb 2009
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Positive MRSA culture
Who cannot join
- Patients currently on or start antibiotic therapy directed for MRSA.(Prophylaxis antibiotic for surgical procedure not considered therapy.)
- Patients with MRSA infected wounds
- Patients under the age of 18 years
- A woman currently pregnant or nursing a child
- Patients participating in another study within 30 days of randomization
About this study
Official title: Comparison of Decolonization of MRSA Using Theraworx
The purpose of this study is to examine treatment method of Methicillin-resistant Staphylococcus aureus (MRSA) decolonization in patients.
Read the detailed description
Decolonization therapy is indicated for management of patients with MRSA. Theraworx is reported to be an effective antimicrobial against multiple organisms. In this study, patients with positive MRSA colonization culture will be treated with Theraworx to evaluate decolonization duration capability.
- Being tested
- Theraworx, mupirocin antibiotic ointment
- Keywords
- Methicillin resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraworxOther
Theraworx swab intranasal BID for 5 days
mupirocin antibiotic ointmentDrug
mupirocin antibiotic ointment swab intranasal BID for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | No Treatment |
| 2 | Experimental | Theraworx intranasal Receives: Other: Theraworx |
| 3 | Active comparator | mupirocin antibiotic ointment intranasal Receives: Drug: mupirocin antibiotic ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of decolonization confirmed by intranasal culture
Measured: Up to 14 days post treatment (+/- 1-2 days)
Secondary outcomes (1)
Economic-Cost comparison of treatment Evidence of decolonization
Measured: 5 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Lack of patient recruitment.
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger E Huckfeldt, MD, Principal investigator, Mercy/St. John's Hospital - Springfield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713674
- Sponsor's protocol ID
- SJMRSA-01
- Acronym
- SJMRSA
- Status last verified
- Mar 2017
- First submitted
- 7 Jul 2008
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Decolonization of MRSA Using Theraworx
- ClinicalTrials.gov ID
- NCT00713674
- Acronym / sponsor ID
- SJMRSA / SJMRSA-01
- Keywords
- Methicillin resistance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of patient recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mercy ResearchUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Jul 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.
The purpose of this study is to examine treatment method of Methicillin-resistant Staphylococcus aureus (MRSA) decolonization in patients.
Detailed description
Decolonization therapy is indicated for management of patients with MRSA. Theraworx is reported to be an effective antimicrobial against multiple organisms. In this study, patients with positive MRSA colonization culture will be treated with Theraworx to evaluate decolonization duration capability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –No Treatment |
| 2 | Experimental | Other: TheraworxTheraworx intranasal |
| 3 | Active comparator | Drug: mupirocin antibiotic ointmentmupirocin antibiotic ointment intranasal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive MRSA culture
Key exclusion criteria (5 listed)
- Patients currently on or start antibiotic therapy directed for MRSA.(Prophylaxis antibiotic for surgical procedure not considered therapy.)
- Patients with MRSA infected wounds
- Patients under the age of 18 years
- A woman currently pregnant or nursing a child
- Patients participating in another study within 30 days of randomization
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 |
|---|---|---|
| TheraworxTheraworx swab intranasal BID for 5 days | Other | 2 |
| mupirocin antibiotic ointmentmupirocin antibiotic ointment swab intranasal BID for 5 days | Drug | 3 |
Primary outcome
Evidence of decolonization confirmed by intranasal culture
Time frame: Up to 14 days post treatment (+/- 1-2 days)
1 secondary outcome
Economic-Cost comparison of treatment Evidence of decolonization
Time frame: 5 days of treatment
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 23 Mar 2017.
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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.
Roger E Huckfeldt, MD principal investigator
Mercy/St. John's Hospital - Springfield
Questions about this trial
What is this clinical trial studying?
A study testing Theraworx and mupirocin antibiotic ointment in people with Methicillin-Resistant Staphylococcus Aureus, run by Mercy Research.
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 5 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 23 Mar 2017. 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?
Evidence of decolonization confirmed by intranasal culture (time frame: Up to 14 days post treatment (+/- 1-2 days)). 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 2017.