Multiple doses of HT61 formulations in Staph aureus carriers

• Research type

  Research Study

• Full title

  A randomised, open-labelled, multiple dose study of HT61 formulations applied to the anterior nares plus chlorhexidine body and hair washes in subjects with nasal carriage of Staphylococcus aureus

• IRAS ID

  57457

• Contact name

  JJorg Taubell

• Sponsor organisation

  Helperby Thearapeutics Ltd

• Eudract number

  2010-021193-11

• ISRCTN Number

  N/A

• Research summary

  Staphylococcus aureus is a species of bacterium commonly found on the skin and/or in the noses of healthy people. Although it is usually harmless at these sites, it may occasionally get into the body (e.g. through breaks in the skin such as cuts, wounds or surgical incisions) and cause infections. These infections may be mild (e.g. pimples or boils) or serious (e.g. infection of the bloodstream, bones or joints). MRSA stands for methicillin-resistant Staphylococcus aureus, which is a type of Staphylococcus aureus that's resistant to the anti-bacterial activity of most antibiotics in the penicillin class. MRSA is now present in most hospitals in the UK and most people carry bacteria in and on their body skin and in their nose. Carriage of MRSA does not harm most people, but the bacterium can be passed onto other people. If the carrier has surgery, it can enter the wound and cause a clinical infection, which is difficult to treat, because the organism is often resistant to a wide range of antibiotics. Therefore, there is a need for a new topical (applied to the outside of the body) antibiotic to clear the nose of MRSA. The aim of this study is to compare the effectiveness of HT61 (the study medication) using 3 different formulation methods. The effectiveness of HT61 will be determined by taking swabs from the nose (inside the nostrils) as this is where MRSA bacteria normally live. The rate of Staphylococcus aureus ("MRSA/Staphylococcus aureus") re-occurrence will also be assessed as well as the safety and levels of HT61 in the blood.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/76

• Date of REC Opinion

  25 Aug 2010

• REC opinion

  Further Information Favourable Opinion