A Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of Topical LTX-109 in Subje… (NCT01158235) | Clinical Trial Compass
CompletedPhase 1/2
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)
Sweden24 participantsStarted 2010-05
Plain-language summary
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.
Who can participate
Age range16 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female subjects between the ages of 16 and 75, inclusive.
* Female subjects must be non-pregnant, non-lactating.
* Female subjects of child bearing potential and male subjects with female partners of child-bearing potential must use an adequate form of diaphragm or condom with spermicidal prior to entry into the study and two weeks following the completion of all follow-up procedures 9 weeks after treatment. Hormone contraception or hormonal IUDs alone are not acceptable contraception
* Signed and dated written informed consent by subject.
* Subject's medical condition is stable, with no clinically significant abnormalities.
* Subject's pre-study laboratory screen of haematology, clinical chemistry and urinalysis are normal or if abnormal, not considered clinically significant.
* Subjects must be able to understand the subject information and the consent form, and be willing to return to the study site for follow up visits, comply with requirements, instructions and restrictions of the study listed in the informed consent form.
* All family members, to a subject carrying MRSA (not applicable for MSSA positive) should also be screened for MRSA. Subjects that are eligible may be included in the study, and family members not eligible or willing to participate should be offered treatment for decolonization of MRSA according to standard treatment and investigators choice.
Exclusion Criteria:
* Negative nasal culture for MRSA/MSSA on the first scre…
What they're measuring
1
Local tolerability in the anterior nares
Timeframe: Day 1, 2, 3. week 2-9 after final treatment.