Orthopedic ProceduresPhase 2TOPS-MRSANCT00903279
Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery
A Phase 2 study testing Altabax (retapamulin) in people with Orthopedic Procedures and Methicillin-resistant Staphylococcus Aureus, run by Bay Pines VA Healthcare System at 1 site in United States.
Trial summary
The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Procedures, Methicillin-resistant Staphylococcus Aureus
- What is being tested?
- Altabax (retapamulin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2010
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who are admitted for an orthopedic surgical procedure
- All patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for MRSA
Who cannot join
- Pregnancy
- Serious systemic illness due to renal, cardiac or hepatic disease
- Inability to complete follow-up assessments
- Allergy or intolerance to retapamulin
- BMI > 30
- Uncontrolled diabetes, severe anemia, thrombocytopenia or an underlying hematopoietic disorder or malignancy
- Patients with serious life-threatening illnesses and those with terminal illness not expected to survive for two years or more will not be enrolled
- Antibiotics administered during the course of the study will be recorded (name, dose and dates)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)
The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.
Read the detailed description
Enhanced characterization of MRSA strains carried by patients and their eradication prior to surgery will significantly reduce healthcare costs to the VA by reducing the number of MRSA positive patients who need to be isolated and or closely monitored, and allow healthcare providers to better predict the patient's requirements. In addition, the application of molecular methods will facilitate faster tracking of MRSA postoperative infections.
- Being tested
- Placebo, Altabax (retapamulin)
- Keywords
- MRSA colonization, Orthopedic Surgery, Altabax, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.
Altabax (retapamulin)Drug
Also called Retapamulin
Retapamulin 1% ointment will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Altabax | Experimental | Not described Receives: Drug: Altabax (retapamulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization
Measured: 30 days
Secondary outcomes (1)
Identify a predominant clone among the MRSA isolates in this study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startAug 2009
- Study completionDec 2010 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic ProceduresStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bay Pines VA Healthcare System
- Sponsor type
- US federal agency
- Investigators
- Suzane Silbert, PhD, Study director, Bay Pines VAHCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903279
- Sponsor's protocol ID
- TOPS2009
- Acronym
- TOPS-MRSA
- Status last verified
- May 2009
- First submitted
- 14 May 2009
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)
- ClinicalTrials.gov ID
- NCT00903279
- Acronym / sponsor ID
- TOPS-MRSA / TOPS2009
- Keywords
- MRSA colonization, Orthopedic Surgery, Altabax, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bay Pines VA Healthcare SystemUS federal agency
- Study start
- Aug 2009
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 May 2009 (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 investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.
Detailed description
Enhanced characterization of MRSA strains carried by patients and their eradication prior to surgery will significantly reduce healthcare costs to the VA by reducing the number of MRSA positive patients who need to be isolated and or closely monitored, and allow healthcare providers to better predict the patient's requirements. In addition, the application of molecular methods will facilitate faster tracking of MRSA postoperative infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Altabax | Experimental | Drug: Altabax (retapamulin) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are admitted for an orthopedic surgical procedure
- All patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for MRSA
Key exclusion criteria (8 listed)
- Pregnancy
- Serious systemic illness due to renal, cardiac or hepatic disease
- Inability to complete follow-up assessments
- Allergy or intolerance to retapamulin
- BMI > 30
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 |
|---|---|---|
| PlaceboPlacebo will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery. | Drug | Placebo |
| Altabax (retapamulin)Also: RetapamulinRetapamulin 1% ointment will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery. | Drug | Altabax |
Primary outcome
Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization
Time frame: 30 days
1 secondary outcome
Identify a predominant clone among the MRSA isolates in this study
Time frame: 2 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 31 Jan 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.
Suzane Silbert, PhD study director
Bay Pines VAHCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Altabax (retapamulin) in people with Orthopedic Procedures and Methicillin-resistant Staphylococcus Aureus, run by Bay Pines VA Healthcare System at 1 site in United States.
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 8 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 31 Jan 2017. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization (time frame: 30 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 31 Jan 2017.