An efficacy study of HT61.
Research type
Research Study
Full title
A randomised, single blind, multiple dose, efficacy study of HT61 alone and in combination with marketed antibiotics, applied to the anterior nares in subjects with nasal carriage of staphylococcus aureus (S.aureus).
IRAS ID
83531
Contact name
Pui Man Leung
Sponsor organisation
Helperby Therapeutics Limited
Eudract number
2011-002438-38
ISRCTN Number
1
Research summary
The drug that is being tested is HT61, a new antibiotic drug which is being developed for the treatment of MRSA (methicillin-resistant Staphylococcus aureus). Carriage of MRSA does not harm most people, but the bacterium can be passed on to other people who may be at risk (e.g. if they have had surgery) and then can cause a clinical infection. Such infections are difficult to treat because the MRSA bacterium 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 which is effective at clearing MRSA from the person who is carrying it (i.e. killing the MRSA bacteria) Two previous studies have been carried out in 29 participants using the HT61 ointment. Overall, HT61 has been well tolerated with only a few instances of dryness or redness of the nose observed. This study will assess the effectiveness of HT61 alone and in combination with Bactroban© and Naseptin© (two medicines currently being used for treating MRSA). During the study 21 healthy subjects carrying nasal S. aureus will be allocated to one of the five treatments: 1) HT61 placebo, 2) HT61 alone (up to 15%), 3) HT61 in combination with Bactroban©, 4) HT61 in combination with Naseptin©, 5) Naseptin© alone. The exact concentration of HT61 and the length of treatment will be determined from an ongoing clinical study (HT08) at Simbec. The total number of subjects could be increased up to 75 (15 subjects per treatment) based on a review of the preliminary results from the swabs taken up to 7 days post dosing from the initial 21 subjects. Based on results obtained from treatment 2 and 3 it might be decided to have a group of at least 3 subjects to receive Bactroban© treatment alone.
REC name
Wales REC 2
REC reference
12/WA/0010
Date of REC Opinion
21 Feb 2012
REC opinion
Further Information Favourable Opinion