Nasal Carriers MRSAPhase 1/2NCT01158235
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)
A Phase 1/2 study testing LTX-109 in people with Nasal Carriers MRSA, run by Lytix Biopharma AS at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Carriers MRSA
- What is being tested?
- LTX-109
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- May 2010to Apr 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- MRSA decolonization attempt in the previous 6 months (prior treatment for a MRSA infection is not an exclusion criterion).
- Systolic BP is ≥170 mmHg, or diastolic BP is ≥100 mmHg or HR is ≥110 bpm.
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- 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.
- Known positive test for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen or hepatitis C virus antibody.
- Other unspecified reasons that, in the opinion of the investigator make the subject unsuitable for enrolment.
- Treatment with an investigational drug within 30 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the detailed description
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% Lytixar™ or placebo, next group 2% Lytixar™ or placebo and finally 5% Lytixar™ or placebo. Dose escalation will be performed after a brief safety evaluation of the tolerability after application of Lytixar™/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.
- Conditions
- Nasal Carriers MRSA
- Being tested
- LTX-109
- Keywords
- MRSA, nose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTX-109Drug
Also called Lytixar
1%, 2% and 3% Lytixar (gel formulation). TID for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: LTX-109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, 2, 3. week 2-9 after final treatment.
Secondary outcomes (1)
To evaluate recurrence of MRSA/MSSA during the observation period.
Measured: Week 2 to Week 9 after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal Carriers MRSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lytix Biopharma AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anna Nilsson, MD, PhD, Principal investigator, Skåne University hospital, Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158235
- Sponsor's protocol ID
- C10-109-02
- Status last verified
- Jun 2011
- First submitted
- 7 Jul 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25331699
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT01158235
- Acronym / sponsor ID
- C10-109-02
- Conditions
- Nasal Carriers MRSA
- Keywords
- MRSA, nose
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Lytix Biopharma ASIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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% Lytixar™ or placebo, next group 2% Lytixar™ or placebo and finally 5% Lytixar™ or placebo. Dose escalation will be performed after a brief safety evaluation of the tolerability after application of Lytixar™/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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LTX-109 (Lytixar) | Experimental | Drug: LTX-109Ascending 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
- MRSA decolonization attempt in the previous 6 months (prior treatment for a MRSA infection is not an exclusion criterion).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTX-109Also: Lytixar1%, 2% and 3% Lytixar (gel formulation). TID for 3 days. | Drug | LTX-109 (Lytixar) |
Primary outcome
Local tolerability in the anterior nares
Time frame: Day 1, 2, 3. week 2-9 after final treatment.
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.
1 secondary outcome
To evaluate recurrence of MRSA/MSSA during the observation period.
Time frame: Week 2 to Week 9 after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Derived from this study: PubMed 25331699Nilsson 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Nilsson, MD, PhD principal investigator
Skåne University hospital, Malmö
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LTX-109 in people with Nasal Carriers MRSA, run by Lytix Biopharma AS at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tolerability in the anterior nares (time frame: Day 1, 2, 3. week 2-9 after final treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.