Clinical trial NCT03304873: Retapamulin as a Decolonizing Agent for MRSA
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: MRSA
Keywords: rectal MRSA
mupirocin-resistant nasal MRSA
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 47
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo
timeFrame: 1 Week
measure: Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jennifer Lighter, MD
role: PRINCIPAL_INVESTIGATOR
References: