MRSAPhase 3NCT03304873
Retapamulin as a Decolonizing Agent for MRSA
A Phase 3 study testing Retapamulin in people with MRSA, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy of retapamulin to reduce carriage of MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. Read more about this study
- Who is it for?
- Ages 9 months to 17 years
- Conditions the study is for
- MRSA
- What is being tested?
- Retapamulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 18 Mar 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 9 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admission to the general pediatric floor and pediatric intensive care units at NYU Langone Medical Center or visit to study team members at ODA clinic (Park Ave locations) in Williamsburg Brooklyn.
- Ages 9 months to 17 years
- Residing in the zip codes which reflect Orthodox Jewish neighborhoods where there is a current outbreak of this strain of MRSA.
- Nasal and/or rectal culture positive for mupirocin-resistant methicillin-resistant Staphylococcus aureus (MRSA)
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnant or lactating
- Unable to appropriately consent
- Open sores in either of the study sites (nares or rectum)
- Recent surgical procedure to either study site (nares or rectum)
- Concurrent use of Rifampin or Trimethoprim/Sulfamethoxazole
Show all 9Show fewer
- Current active MRSA infection
- Immunocompromised
- Presence of endotracheal tube, tracheostomy tube or other foreign body in upper airway
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Retapamulin as a Topical Decolonizing Agent for Mupirocin Resistant Methicillin Resistant Staphylococcus Aureus (MRSA)
The purpose of this study is to investigate the efficacy of retapamulin to reduce carriage of MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. The sample size will include 27 subjects in each of the two arms of the study (retapamulin versus placebo) for a total of 54 subjects. Participants who are found to be nasal and/or rectal colonized with MRSA will be randomized to receive either retapamulin or placebo applied nasally and rectally for a total of 5 days. Nasal and rectal swabs will be collected at pre-defined time points during study duration (screening swab, swab one week after completion of topical therapy, swab 4 weeks after completion of topical therapy) to assess MRSA colonization status. The colonization rates of both groups will be assessed via Fisher's Exact Test.
- Conditions
- MRSA
- Being tested
- Retapamulin, Placebo Ointment
- Keywords
- rectal MRSA, mupirocin-resistant nasal MRSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetapamulinDrug
Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).
Placebo OintmentDrug
The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.
| Study group | Role | What they receive |
|---|---|---|
| Retapamulin | Experimental | Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days. Receives: Drug: Retapamulin |
| Placebo | Placebo comparator | The placebo used will be a triple purified pharmaceutical grade white petrolatum Receives: Drug: Placebo Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo
Study visit for nasal/peri-rectal swabs
Measured: 1 Week
Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo
Study visit for nasal/peri-rectal swabs
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start1 Dec 2017
- Primary completion13 Feb 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MRSAStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Lighter, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304873
- Sponsor's protocol ID
- 17-00907
- Status last verified
- Mar 2020
- First submitted
- 4 Oct 2017
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Retapamulin as a Topical Decolonizing Agent for Mupirocin Resistant Methicillin Resistant Staphylococcus Aureus (MRSA)
- ClinicalTrials.gov ID
- NCT03304873
- Acronym / sponsor ID
- 17-00907
- Conditions
- MRSA
- Keywords
- rectal MRSA, mupirocin-resistant nasal MRSA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Posted 19 Mar 2020
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 investigate the efficacy of retapamulin to reduce carriage of MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. The sample size will include 27 subjects in each of the two arms of the study (retapamulin versus placebo) for a total of 54 subjects. Participants who are found to be nasal and/or rectal colonized with MRSA will be randomized to receive either retapamulin or placebo applied nasally and rectally for a total of 5 days. Nasal and rectal swabs will be collected at pre-defined time points during study duration (screening swab, swab one week after completion of topical therapy, swab 4 weeks after completion of topical therapy) to assess MRSA colonization status. The colonization rates of both groups will be assessed via Fisher's Exact Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retapamulin | Experimental | Drug: RetapamulinThin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days. |
| Placebo | Placebo comparator | Drug: Placebo OintmentThe placebo used will be a triple purified pharmaceutical grade white petrolatum |
Who may qualify
- Ages
- 9 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Admission to the general pediatric floor and pediatric intensive care units at NYU Langone Medical Center or visit to study team members at ODA clinic (Park Ave locations) in Williamsburg Brooklyn.
- Ages 9 months to 17 years
- Residing in the zip codes which reflect Orthodox Jewish neighborhoods where there is a current outbreak of this strain of MRSA.
- Nasal and/or rectal culture positive for mupirocin-resistant methicillin-resistant Staphylococcus aureus (MRSA)
Key exclusion criteria (9 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnant or lactating
- Unable to appropriately consent
- Open sores in either of the study sites (nares or rectum)
- Recent surgical procedure to either study site (nares or rectum)
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 |
|---|---|---|
| RetapamulinRetapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%). | Drug | Retapamulin |
| Placebo OintmentThe placebo that will be used is triple-purified pharmaceutical-grade petrolatum. | Drug | Placebo |
Primary outcome
Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo
Time frame: 1 Week
Study visit for nasal/peri-rectal swabs
Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo
Time frame: 4 Weeks
Study visit for nasal/peri-rectal swabs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for MRSA
Enrolling by invitationPhase 4
Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?
Staphylococcus Aureus Bacteremia
Not yet recruitingObservational study
Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis
Atopic Dermatitis (AD), Scabies
RecruitingPhase 4
Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia
Staphylococcus Aureus Septicemia, Staphylococcus Aureus Bacteremia
Not yet recruitingObservational study
Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus
Staphylococcal Aureus Infection, Surgical Site Infection (SSI)
Not yet recruitingPhase 2
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA)
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.
Jennifer Lighter, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Retapamulin in people with MRSA, run by NYU Langone Health 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 19 Mar 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo (time frame: 1 Week). The study lists 2 primary outcomes in all. 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 19 Mar 2020.