Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot study conducted to evaluate the safety, local tolerability and efficacy of LTX-109(Lytixarâ„¢), a lytic peptide designed to kill bacterias quickly and efficient. LTX-109 (Lytixarâ„¢)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 Lytixarâ„¢ 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% Lytixarâ„¢ or placebo, next group 2% Lytixarâ„¢ or placebo and finally 5% Lytixarâ„¢ or placebo. Dose escalation will be performed after a brief safety evaluation of the tolerability after application of Lytixarâ„¢/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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTX-109 (Lytixar) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTX-109 | Drug | 1%, 2% and 3% Lytixar (gel formulation). TID for 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerability in the anterior nares | 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. | Day 1, 2, 3. week 2-9 after final treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate recurrence of MRSA/MSSA during the observation period. | Week 2 to Week 9 after treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anna Nilsson, MD, PhD | Skåne University hospital, Malmö | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital | Malmö | 205 02 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25331699 | Derived | Nilsson AC, Janson H, Wold H, Fugelli A, Andersson K, Hakangard C, Olsson P, Olsen WM. LTX-109 is a novel agent for nasal decolonization of methicillin-resistant and -sensitive Staphylococcus aureus. Antimicrob Agents Chemother. 2015 Jan;59(1):145-51. doi: 10.1128/AAC.03513-14. Epub 2014 Oct 20. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C568461 | L-arginyl-2,5,7-tris(1,1-dimethylethyl)-L-tryptophyl-N-(2-phenylethyl)-L-argininamide |
Not provided
Not provided
Not provided