Study to determine the efficacy of XF-73 in eradicating Staph aureus.
Research type
Research Study
Full title
A phase I/II randomised,double-blind,placebo-controlled study of the nasal decolonisation of Staphylococcus aureus(SA) and the safety and tolerability of two concentrations of intra-nasal XF-73 gel in healthy subjects
IRAS ID
160531
Contact name
JM Ritter
Contact email
Sponsor organisation
Destiny Pharma Ltd
Eudract number
2014-001963-11
Research summary
XF-73 is a new drug that may be useful in the removal of Staphylococcus aureus from the nose.
This study is to examine the safety and tolerability of two different strengths (2.0mg/g and 0.5mg/g) of XF-73 in eradicating Staphylococcus aureus (a common germ that lives on the skin or in the nose of some healthy people) in the nose as compared to dummy drug.
This will not be the first time this drug will be given to humans. Three studies have been completed with XF-73 involving 100 healthy subjects of whom 44 received similar drug strengths as in this present study, given at similar intervals, and another study is underway.
XF-73 will be applied to the nostrils as a gel twice daily for two days in combination with daily body and face washing with chlorhexidine gluconate (a form of antiseptic agent) cloths to prevent contamination of the nostrils from other skin sites.
Volunteers will be admitted for 5 days in the clinic. Dosing with XF-73 will occur on Days 1 and 2. They will be discharged on Day 4 and return for out-patient visits on Day 7 and Day 14.
60 healthy male or female subjects aged between 18 and 75 years, who are confirmed to be persistent nasal staphylococcus aureus carriers will be enrolled into the study. Persistent nasal carriage will be confirmed by three positive cultures for Staph aureus from nasal swabs.REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/1145
Date of REC Opinion
5 Sep 2014
REC opinion
Further Information Favourable Opinion