Trial Outcomes & Findings for Study to Assess Eradication of Nasal Carriage of Staphylococcus Aureus (SA) With Mupirocin (Bactroban 2% Nasal Ointment) (NCT NCT02284555)

Last Updated: 2016-03-01

Results Overview

Apparent eradication demonstrated by a semi-quantitative score of negative or zero using a broth enriched culture microbial assay.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

48 hours after the last dose of mupirocin 2%

Results posted on

2016-03-01

Participant milestones
Measure	Mupirocin 2% Nasal Ointment Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC). Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Study to Assess Eradication of Nasal Carriage of Staphylococcus Aureus (SA) With Mupirocin (Bactroban 2% Nasal Ointment)

Baseline characteristics by cohort
Measure	Mupirocin 2% Nasal Ointment n=12 Participants Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC). Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC.
Age, Continuous	40.8 years STANDARD_DEVIATION 14.21 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: 48 hours after the last dose of mupirocin 2%

Apparent eradication demonstrated by a semi-quantitative score of negative or zero using a broth enriched culture microbial assay.

Outcome measures
Measure	Mupirocin 2% Nasal Ointment n=12 Participants Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC). Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC.
Apparent Eradication of Nasal Carriage of SA	9 participants

Timeframe: 5 day treatment period and follow-up at 7 and 14 days

Outcome measures
Measure	Mupirocin 2% Nasal Ointment n=12 Participants Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC). Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC.
The Number of Subjects With Adverse Events and Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests Assessed Over the Five Day Treatment Period and Follow-up at 7 and 14 Days Relative to the First Dose.	0 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Destiny Pharma

Phone: +44 (0)1273 704440

Restriction type: OTHER