Study to Assess Eradication of Nasal Carriage of Staphylococcus Aureus (SA) With Mupirocin (Bactroban 2% Nasal Ointment)
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|ClinicalTrials.gov Identifier: NCT02284555|
Recruitment Status : Completed
First Posted : November 6, 2014
Results First Posted : March 1, 2016
Last Update Posted : March 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Staphylococcal Infection||Drug: Mupirocin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Centre, Open, Non-controlled Study in Healthy Subjects to Assess the Eradication of Nasal Carriage of Staphylococcus Aureus (SA) Following a Five Day Course of Mupirocin (Bactroban 2% Nasal Ointment) Using a Broth Enriched Culture Microbiological Assessment.|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Experimental: 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 (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC.
Other Name: Bactroban
- Apparent Eradication of Nasal Carriage of SA [ Time Frame: 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.
- 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. [ Time Frame: 5 day treatment period and follow-up at 7 and 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284555
|Simbec Reseach Ltd|
|Wales, United Kingdom, CF48 4DR|
|Study Director:||Ian Mr Hayter, BSc||Destiny Pharma Plc|