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)
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|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|
|Actual Primary Completion Date :||April 2011|
|Actual 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|