Host Defence Peptides
Nasal Decolonization of Staphylococcus Aureus
There is an established link between successful decolonization of S. aureus and reduced perioperative infection risk for high-risk surgery patients. The study aims to demonstrate the safety and preliminary efficacy of LTX-109 as an innovative antimicrobial reagent for prophylactic decolonisation of nasal S. aureus in connection with elective surgery. Nasal decolonisation with LTX-109 is expected to reduce nosocomial S. aureus infections, both MSSA and MRSA, with a very low likelihood of resistance development because of LTX-109’s novel mechanism of action.
The participating subjects will be treated with an intensive dosing regimen. Compared to a “standard of care” dosing regimen with treatment for up to five days, the aim is to obtain satisfactory results after only six hours of treatment. There are several future benefits linked to this regimen: Patients will be more rapidly eligible for surgery and the compliance will most likely be improved.
persistent carriage of S. aureus (MSSA and/or MRSA).
– To determine the extent of systemic absorption of LTX-109 after application to the anterior nares
Number of subjects planned
Approximately 60 subjects will be screened to achieve enrolment of 16 randomised and dosed subjects. For more information regarding the ongoing study, see: https://clinicaltrials.gov/ct2/show/NCT04767321?term=pharma+holdings&draw=2
Time Frame: Interim analysis after 3 weeks. End point analysis after 6 weeks. Follow-up analysis after 3 months.
▪ Investigator scored measures assessed by Hidradenitis suppurativa score (Sartorius), and number of inflammatory lesions and IHS-4.
▪ Covariate analysis on patient recorded DLQI and self-reported disease activity and pain experience in relation to pre-registered variables.
▪ Patient recorded DLQI and self-reported disease activity and pain experience in relation to clinical phenotypes (Hidradenitis suppurativa score (Sartorius), Hurley stage, IHS- 4).
Approximately 16 patients are planned enrolled in the study.
For more information regarding the ongoing study, see: https://clinicaltrials.gov/ct2/show/NCT04756336?term=pharma+holdings&draw=2
The primary endpoint is reduction in SARS-CoV-2 viral load from baseline (pre-dose) to 2 hours (h) post-dosing.
– To evaluate safety and tolerability of a single dose of LTX-109 3% nasal gel, as compared to placebo.
A total of 60 subjects will be randomised 1:1 to one single dose of either active treatment (LTX-109 3% hydrogel) or matching placebo.
For more information regarding the ongoing study, see: