A 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)
|ClinicalTrials.gov Identifier: NCT01158235|
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : June 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Nasal Carriers MRSA||Drug: LTX-109||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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)|
|Study Start Date :||May 2010|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Experimental: LTX-109 (Lytixar)
Ascending dose study. Start enrollment to group 1: 1% LTX-109/placebo, then group 2: 2%LTX-109/placebo and finally group 3: 5%LTX-109/placebo dosed in each nostril TID for 3 consecutive days.
1%, 2% and 3% Lytixar (gel formulation). TID for 3 days.
Other Name: Lytixar
- Local tolerability in the anterior nares [ Time Frame: Day 1, 2, 3. week 2-9 after final treatment. ]To explore safety, local tolerability and efficacy of LTX-109 when applied topically into the anterior nares in subjects with nasal colonisation of MRSA/MSSA. To determine the extent of systemic absorption of LTX -109 when applied to the anterior nares.
- To evaluate recurrence of MRSA/MSSA during the observation period. [ Time Frame: Week 2 to Week 9 after treatment. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158235
|Skåne University Hospital|
|Malmö, Sweden, 205 02|
|Principal Investigator:||Anna Nilsson, MD, PhD||Skåne University hospital, Malmö|