An antimicrobial product for removal of bacteria from inside the nose.

• Research type

  Research Study

• Full title

  A randomised, placebo-controlled trial to investigate the effectiveness of an antimicrobial product in the elimination of Staphylococcus aureus colonisation from the anterior nares of adult subjects with atopic eczema. A proof of concept study (the NASSAELIM pilot).

• IRAS ID

  85215

• Contact name

  Robert Adams

• Contact email

  robert.adams@simbec.com

• Eudract number

  2011-004183-29

• Research summary

  This pilot clinical trial is to investigate if use of an antimicrobial cream in the nose of subjects with atopic eczema can remove nasal Staphylococcus aureus (SA) colonisation.
  SA is often found on the skin of patients with atopic eczema, and there is strong evidence supporting a link between SA colonisation and worsening of this condition (flares). It is common medical practice to try to manage the levels of SA on the skin, however, in these patients SA is also often found in the nose, which acts as a source for generalised colonisation of the skin. Repeated use of antibiotics in the nose is unsuitable for eradicating SA in eczema patients as it may cause bacterial resistance. Antiseptics may be a better alternative for long term use, as they are less prone to resistance.
  The purpose of this study is to test a licensed antiseptic cream (which is already used in the management of eczema) to find out if it is effective for eradicating nasal carriage of SA. Subjects must be aged 16 years and over, diagnosed with atopic eczema and found, by swabbing, to have nasal SA. The study will be carried out at a study centre run by a Clinical Research Organisation (CRO) appointed by the sponsor. It is estimated that it will take around 4 months to microbiologically screen sufficient numbers of subjects (estimated in the range 60 to 100) to identify 36 SA carriers eligible for randomisation to either the test cream or a placebo comparator. Subjects will be asked to instil their assigned treatment into both nostrils 3 times a day for 7 days. Microbiological testing will then be repeated, and for those testing negative for SA, the testing will be repeated for up to 4 weeks after treatment to monitor rates of nasal re-colonisation.
  

• REC name

  Wales REC 2

• REC reference

  14/WA/0188

• Date of REC Opinion

  25 Jun 2014

• REC opinion

  Favourable Opinion