MRSA
Conditions
Keywords
rectal MRSA, mupirocin-resistant nasal MRSA
Brief 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. 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.
Interventions
DRUGRetapamulin
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%).
DRUGPlacebo Ointment
The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Ages 9 months to 17 years 3. Residing in the zip codes which reflect Orthodox Jewish neighborhoods where there is a current outbreak of this strain of MRSA. 4. Nasal and/or rectal culture positive for mupirocin-resistant methicillin-resistant Staphylococcus aureus (MRSA)
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: 1. Pregnant or lactating 2. Unable to appropriately consent 3. Open sores in either of the study sites (nares or rectum) 4. Recent surgical procedure to either study site (nares or rectum) 5. Concurrent use of Rifampin or Trimethoprim/Sulfamethoxazole 6. Current active MRSA infection 7. Immunocompromised 8. Presence of endotracheal tube, tracheostomy tube or other foreign body in upper airway
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo | 1 Week | Study visit for nasal/peri-rectal swabs |
| Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo | 4 Weeks | Study visit for nasal/peri-rectal swabs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Retapamulin 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.
Retapamulin: 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%). | 23 |
| Placebo The placebo used will be a triple purified pharmaceutical grade white petrolatum
Placebo Ointment: The placebo that will be used is triple-purified pharmaceutical-grade petrolatum. | 24 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 8 |
Baseline characteristics
| Characteristic | Placebo | Total | Retapamulin |
|---|---|---|---|
| Age, Continuous | 3.5 years | 3.5 years | 3.9 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 24 participants | 48 participants | 23 participants |
| Sex: Female, Male Female | 10 Participants | 28 Participants | 18 Participants |
| Sex: Female, Male Male | 14 Participants | 19 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 14 / 23 | 0 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 |
Outcome results
Primary
Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo
Study visit for nasal/peri-rectal swabs
Time frame: 4 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retapamulin | Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo | 12 Participants |
| Placebo | Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo | 9 Participants |
p-value: 0.99t-test, 1 sided
Primary
Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo
Study visit for nasal/peri-rectal swabs
Time frame: 1 Week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retapamulin | Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo | 2 Participants |
| Placebo | Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo | 13 Participants |
p-value: 0.0004t-test, 1 sided