A study to investigate Bactroban (2%) in healthy volunteers

  • Research type

    Research Study

  • Full title

    A SINGLE CENTRE, OPEN, NON-CONTROLLED STUDY IN HEALTHY SUBJECTS TO ASSESS THE ERADICATION OF NASAL CARRIAGE OF Staphylococcus Aureus FOLLOWING A FIVE DAY COURSE OF MUPIROCIN (BACTROBAN® 2% NASAL OINTMENT) USING A BROTH ENRICHED CULTURE MICROBIOLOGICAL ASSESSMENT

  • IRAS ID

    159092

  • Contact name

    Giresh Sharma

  • Contact email

    girish.sharma@simbec.co.uk

  • Eudract number

    2014-002100-25

  • Research summary

    Destiny Pharma Ltd. is developing intra-nasal XF-73 to suppress or eliminate colonising staphylococci, including methicillin Staphylococcus aureus sensitive (MSSA) and resistant (MRSA) strains.

    Mupirocin 2% (Bactroban®) Nasal ointment is a licensed product in the UK indicated for the eradication of nasal carriage of SA, including methicillin-resistant SA (MRSA) and may be considered as a reference product and provide a benchmark for the XF-73 development programme.

    The purpose of this study is therefore to assess the eradication of SA in healthy subjects following treatment with mupirocin 2% (Bactroban® nasal ointment) twice daily for five days, utilising the modern sensitive microbiological technique of broth enriched culture.

    Healthy male or female subjects aged between 18 and 75 years, who are confirmed to be persistent nasal carriers of Staphylococcus aureus will be enrolled into the study.

    Participation in the trial will last for about 15 weeks (Duration depends on occurrence of screening visits).

  • REC name

    East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

  • REC reference

    14/EE/1043

  • Date of REC Opinion

    30 Jul 2014

  • REC opinion

    Further Information Favourable Opinion