Retapamulin as a Decolonizing Agent for MRSA

NCT ID: NCT03304873

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2019-03-18

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.

Conditions

MRSA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Retapamulin

Intervention Type: DRUG

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

The placebo used will be a triple purified pharmaceutical grade white petrolatum

Group Type: PLACEBO_COMPARATOR

Placebo Ointment

Intervention Type: DRUG

The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.

Interventions

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%).

Intervention Type: DRUG

Placebo Ointment

The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.

Intervention Type: DRUG

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

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Lighter, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-00907

Identifier Type: -

Identifier Source: org_study_id