Nasal Carriers MRSA Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled, Ascending Dose Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of Topical LTX-109 in Subjects Nasally Colonized With Methicillin-resistant/-Sensitive Staphylococcus Aureus (MRSA/MSSA)
This is a pilot study conducted to evaluate the safety, local tolerability and efficacy of
LTX-109(Lytixar™), a lytic peptide designed to kill bacterias quickly and efficient. LTX-109
(Lytixar™)will be applied in the anterior nares in subjects who are carriers of nasal
colonies of MRSA/MSSA.
The extent of systemic absorption of LTX -109 when applied to the anterior nares will be
evaluated and the effect of Lytixar™ as to clear colonies of MRSA/MSSA during the the
observation period and Week 2 to Week 9 after treatment.
Subjects with persistent colonies of MRSA/MSSA in the nostril will be recruited to receive either active treatment or placebo. This is a dose escalating study. First grout will receive either 1% Lytixar™ or placebo, next group 2% Lytixar™ or placebo and finally 5% Lytixar™ or placebo. Dose escalation will be performed after a brief safety evaluation of the tolerability after application of Lytixar™/placebo vehicle TID for three days. Pharmacokinetic samples will be collected from subjects who are willing. Subjects will be followed until 9 weeks after initiation of treatment. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)