Trial Outcomes & Findings for Retapamulin as a Decolonizing Agent for MRSA (NCT NCT03304873)

NCT ID: NCT03304873

Last Updated: 2020-03-19

Results Overview

Study visit for nasal/peri-rectal swabs

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 47 participants
• Primary outcome timeframe: 1 Week
• Results posted on: 2020-03-19

Participant Flow

Participant milestones

Measure	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%).	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.
Overall Study STARTED	23	24
Overall Study COMPLETED	22	16
Overall Study NOT COMPLETED	1	8

Reasons for withdrawal

Measure	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%).	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.
Overall Study Lost to Follow-up	1	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Retapamulin n=23 Participants 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%).	Placebo n=24 Participants 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.	Total n=47 Participants Total of all reporting groups
Age, Continuous	3.9 years n=23 Participants	3.5 years n=24 Participants	3.5 years n=47 Participants
Sex: Female, Male Female	18 Participants n=23 Participants	10 Participants n=24 Participants	28 Participants n=47 Participants
Sex: Female, Male Male	5 Participants n=23 Participants	14 Participants n=24 Participants	19 Participants n=47 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	23 participants n=23 Participants	24 participants n=24 Participants	48 participants n=47 Participants

PRIMARY outcome

Timeframe: 1 Week

Study visit for nasal/peri-rectal swabs

Outcome measures

Measure	Retapamulin n=23 Participants 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%).	Placebo n=22 Participants 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.
Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo	2 Participants	13 Participants

PRIMARY outcome

Timeframe: 4 Weeks

Study visit for nasal/peri-rectal swabs

Outcome measures

Measure	Retapamulin n=22 Participants 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%).	Placebo n=16 Participants 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.
Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo	12 Participants	9 Participants

Adverse Events

Retapamulin

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Retapamulin n=23 participants at risk 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%).	Placebo n=24 participants at risk 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.
General disorders Local application site irritation	60.9% 14/23 • Number of events 14 • While on study protocol, which includes while using randomized medication and throughout follow-up (about 6 weeks). Known risks or adverse reactions from this drug use are minimal and include local application site irritation (pruritus, erythema, stinging). In clinical studies, this was found to occur in \< 2% of patients. This information is listed in the package insert for retapamulin. It is expected not to pose greater than minimal risk to participants. Side effects of Retapamulin are not commonly expected and are reported to subside with the discontinuation of the drug without expected long term risks.	0.00% 0/24 • While on study protocol, which includes while using randomized medication and throughout follow-up (about 6 weeks). Known risks or adverse reactions from this drug use are minimal and include local application site irritation (pruritus, erythema, stinging). In clinical studies, this was found to occur in \< 2% of patients. This information is listed in the package insert for retapamulin. It is expected not to pose greater than minimal risk to participants. Side effects of Retapamulin are not commonly expected and are reported to subside with the discontinuation of the drug without expected long term risks.

Additional Information

Jennifer Lighter, MD

NYU Grossman School of Medicine

Phone: 212-263-5454

Email: Jennifer.Lighter@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place