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)

NCT01158235 | Completed Phase 1 DMC

• 1 other identifier: C10-109-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasal Carriers MRSA

Keywords

MRSA; nose

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• To evaluate recurrence of MRSA/MSSA during the observation period.

  Week 2 to Week 9 after treatment.

Study Arms (1)

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.

Drug: LTX-109

Interventions

LTX-109 DRUG

1%, 2% and 3% Lytixar (gel formulation). TID for 3 days.

Also known as: Lytixar

LTX-109 (Lytixar)

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Negative nasal culture for MRSA/MSSA on the first screen visit.
• Negative nasal cultures for MRSA/MSSA at any occasion during the run-in period day -14 to -3 day prior to Baseline.
• Severe eczema (eczema infected with MRSA) or skin wounds, clinically significant according to investigator.
• Previous or concurrent treatment with antimicrobials for an infection within the last 28 days prior to baseline.
• Systolic BP is ≥170 mmHg, or diastolic BP is ≥100 mmHg or HR is ≥110 bpm.
• Inability to take medications nasally.
• Evidence of active rhinitis, sinusitis, or upper respiratory infection.
• 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.
• Significant ongoing or history of drug or alcohol abuse in the opinion of the investigator makes the subject unsuitable for enrolment.
• 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, anti-inflammatory drugs (such as paracetamol and NSAIDs), oral antidiabetics or insulin may be allowed to be included to the study at the discretion of the investigator.
• Known allergic reactions or hypersensitivity of significant severity in general and specifically to any component of the study medication.
• Systemic illness requiring treatment within 28 days prior to baseline.
• Clinically significant illness (defined by the investigator) in the past 4 weeks before the Screening visit.
• 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.
• Current or history of any significant disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.

Sponsors & Collaborators

• Lytix Biopharma AS: lead

Study Sites (1)

Skåne University Hospital

Malmo, 205 02, Sweden

Location

Related Publications (1)

• 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.

  PMID: 25331699 DERIVED

MeSH Terms

Interventions

L-arginyl-2,5,7-tris(1,1-dimethylethyl)-L-tryptophyl-N-(2-phenylethyl)-L-argininamide

Study Officials

• Anna Nilsson, MD, PhD

  Skåne University hospital, Malmö

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 8, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

SE (1)