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).

• Register: EUCTR
• Last refreshed on: 29 May 2012
• Main ID: EUCTR2010-019254-40-SE
• Date of registration: 15/03/2010
• Prospective Registration: Yes
• Primary sponsor: Lytix Biopharma AS
• Public 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).
• Scientific 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).
• Date of first enrolment: 02/11/2010
• Target sample size: 24
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019254-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: ascending dose If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects persistent (non-transient) nasally colonized with MRSA/MSSA
Inclusion criteria:
1) Male and female subjects between the ages of 16 and 75, inclusive.
2) Female subjects must be non-pregnant, non-lactating.
3) Female subjects of child bearing potential and male subjects with female partners of child-bearing potential must use an adequate form of contraception, 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.
4) Signed and dated written informed consent by subject.
5) Subject’s medical condition is stable, with no clinical significant abnormalities.
6) Subject’s pre-study laboratory screen of haematology, clinical chemistry and urinalysis are normal or if abnormal, not considered clinically significant.
7) 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.
8) All family members, to a subject carrying MRSA (not applicable for MSSA positive) should also be screened for MRSA. Subjects that are eligible for the study 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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1) Negative nasal culture for MRSA/MSSA on the first screen visit.
2) Negative nasal cultures for MRSA/MSSA at any occasion during the run-in period day -14 to -3 day prior to Baseline.
3) Severe eczema (eczema infected with MRSA/MSSA) or skin wounds, clinically significant according to investigator.
4) Previous or concurrent treatment with antimicrobials for an infection within the last 28 days prior to baseline.
5) MRSA decolonization attempt in the previous 6 months (prior treatment for a MRSA infection is not an exclusion criterion).
6) Systolic BP is =170 mmHg, or diastolic BP is =100 mmHg or HR is =110 bpm.
7) Inability to take medications nasally.
8) Evidence of active rhinitis, sinusitis, or upper respiratory infection.
9) Disease in the region of the application sites, significant history of trauma or skin disease in the region of the application sites, current nasal skin or nasal septum condition requiring treatment or nasal surgery in the previous 3 months.
10) Significant ongoing or history of drug or alcohol abuse in the opinion of the investigator makes the subject unsuitable for enrolment.
11) Use of prescription or non prescription drugs within minimum 7 days prior to the first dose of study medication. Subjects on stable doses of non-prescription painkillers and anti-inflammatory drugs (such as paracetamol and NSAIDs), oral antidiabetics and insulin are allowed to be included to the study at the discretion of the investigator.
12) Known allergic reactions or hypersensitivity of significant severity in general and specifically to any component of the study medication.
13) Systemic illness requiring treatment within 28 days prior to baseline.
14) Clinically significant illness (defined by the investigator) in the past 4 weeks before the Screening visit.
15) Current or history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, haematological, or metabolic disorder that is not in a stable condition. Malignancy <5 years since final treatment.
16) Current or history of any significant disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
17) Known positive test for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen or hepatitis C virus antibody.
18) Other unspecified reasons that, in the opinion of the investigator make the subject unsuitable for enrolment.
19) Treatment with an investigational drug within 30 days prior to the first dose of study medication.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Nasal decolonization of MRSA/MSSA
MedDRA version: 12.1 Level: LLT Classification code 10067914 Term: Staphylococcal colonisation

Intervention(s)

Product Name: Lytixar
Product Code: LTX-109
Pharmaceutical Form: Gel
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: LTX-109
Other descriptive name: LTX-9
Concentration unit: % (W/W) percent weight/weight
Concentration type: range
Concentration number: 1-5
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Topical use (Noncurrent)

Primary Outcome(s)

Primary end point(s): • Safety measured by standard safety parameters.
• Tolerability measured as local tolerance on the applications sites.
• Decolonization, eradication or no eradication of nasal MRSA/MSSA measured as Colony Forming Units (CFUs)
• The extent of systemic absorption of LTX-109 when applied to the anterior nares, measured in plasma.

Main Objective: To determine:
• Safety and tolerability of LTX-109 when applied topically to the anterior nares three times daily for three days.
• Decolonization, eradication or no eradication of nasal MRSA/MSSA after treatment with LTX-109 over a period of three days
• The extent of systemic absorption of LTX-109 after application to the anterior nares.

Secondary Objective: To determine:
• Recurrence of MRSA/MSSA in the nose during the observation period Week 2 to 9 after treatment.
• Relationship between CFU counts in the nose and the throat and perineum at different time points during and after completed treatment.

Secondary ID(s)

C10-109-02