Nasal Decolonization of Staphylococcus AureusPhase 2NCT05889351
Study to Evaluate the Efficacy, Safety and Tolerability of 3% LTX-109 for Nasal Decolonisation of Staphylococcus Aureus
A Phase 2 study testing LTX-109 3% gel, 4 + 4 applications and LTX-109 3% gel, 4 + 2 applications in people with Nasal Decolonization of Staphylococcus Aureus, run by Pharma Holdings AS at 1 site in Sweden.
Trial summary
A Phase IIa, double-blind, placebo-controlled, randomised study designed to evaluate the efficacy, safety and tolerability of two dosing regimens with LTX-109 administered topically to the anterior nares in subjects with persistent carriage of Staphylococcus aureus (S. aureus). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Decolonization of Staphylococcus Aureus
- What is being tested?
- LTX-109 3% gel, 4 + 4 applications and LTX-109 3% gel, 4 + 2 applications
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSweden
- Study dates
- 19 Sep 2022to 28 Oct 2022
- Phase
- Phase 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent for participation in the study.
- Male or female subject aged 18 to 65 years, inclusive.
- Persistent nasal carrier of S. aureus (MSSA), confirmed by 2 positive bacterial cultures from the nose during the screening period.
- Medically healthy subjects without abnormal clinically significant medical history, physical findings, vital signs, or laboratory values at the time of screening, as judged by the Investigator.
- Women of child bearing potential (WOCBP) had to practice abstinence (only allowed when this was the preferred and usual lifestyle of the subject) or had to agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy from the date of dosing until 2 weeks after last dose. Female subjects had to refrain from donating eggs from the date of dosing until 3 months after dosing with the IMP. Their male partner had to agree to use a condom from date of first dosing until 2 weeks after last dose if he had not undergone vasectomy.
- Male subjects had to be willing to use condom or had to be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and had to refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP. Their female partner of child-bearing potential had to use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above).
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, could either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
- Severe eczema or skin wounds, dry or sensitive skin assessed as clinically significant by the Investigator.
- Any positive result at screening for serum hepatitis B surface antigen, hepatitis C antibody and HIV.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to LTX-109 or chlorhexidine.
- S. aureus (MSSA and/or MRSA) decolonisation attempt in the 6 months prior to - MRSA positive at screening (Visit 1 and/or Visit 2).
Show all 13Show fewer
- Inability to take medications nasally.
- Nasal polyps or significant anatomical nasal abnormality, as judged by the Investigator.
- Evidence of open wound, lesion, inflammation, erythema or infection (including active rhinitis, sinusitis or upper respiratory infection or severe acne vulgaris) affecting the nostril area, lip and skin close to the nose.
- History of multiple episodes (>3) of epistaxis within 12 months prior to screening Visit 2.
- 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 6 months prior to screening Visit 2.
- In situ nasal jewellery or open nasal piercings.
- Previous or concurrent treatment with antimicrobials for an infection within the last 28 days prior to the first administration of IMP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of 3% LTX-109 Compared to Placebo for Nasal Decolonisation of Staphylococcus Aureus.
A Phase IIa, double-blind, placebo-controlled, randomised study designed to evaluate the efficacy, safety and tolerability of two dosing regimens with LTX-109 administered topically to the anterior nares in subjects with persistent carriage of Staphylococcus aureus (S. aureus).
Read the detailed description
Approximately 90 subjects planned screened to achieve 27 randomised and dosed subjects with persistent S. aureus carriage.
On Day 1, subject randomisation in a 2:1 ratio to receive either LTX-109 (n=18) or placebo (n=9). Cohort (1 [8 doses] or 2 [6 doses]) used as a stratification variable to preserve the 2:1 treatment randomisation ratio in each cohort (LTX-109 n=9 or placebo n=5/4).
For all subjects, the IMP was to be applied 4 times during an intensive dosing regimen for 4 ½-hours (on Day 1 at 0, 1 ½, 3 and 4 ½ - hours). For subjects in Cohort 1, this was followed by 4 additional applications: on Day 1 at 12 hours, on Day 2 at 24 and 36 hours, and on Day 3 at 48 hours. For subjects in Cohort 2 the IMP was likewise applied 4 times during the 4 ½-hour period (on Day 1 at 0, 1 ½, 3 and 4½ hours), but was followed by 2 applications: on Day 1 at 12 hours and on Day 2 at 36 hours. On each dosing occasion, a large drop (approximately 250 μL) of IMP was applied into each nostril and distributed to cover the whole area of the nostril. The subjects were carefully monitored by clinical staff during and after dosing. Safety assessments (AEs, vital signs, safety laboratory assessments and local tolerability) and efficacy assessments (nasal swab) were performed.
All subjects were instructed to wash the body and hair with chlorhexidine body wash and shampoo at the CRU on Day 1 (prior to the first dose) and on Day 2. Subjects were provided with chlorhexidine body wash and shampoo for body and hair wash at home on Day 3, Day 4, Day 5, Day 6 and Day 7. On Day 3 and Day 7, subjects used the chlorhexidine shower before the visits to the CRU.
A final end-of-study visit (Visit 5) took place on Day 7 (+2 days) or after early withdrawal.
- Being tested
- Vehicle gel, 4 + 4 applications or 4 + 2 applications, LTX-109 3% gel, 4 + 4 applications, LTX-109 3% gel, 4 + 2 applications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle gel, 4 + 4 applications or 4 + 2 applicationsDrug
Control arm/placebo
LTX-109 3% gel, 4 + 4 applicationsDrug
Cohort 1 active treatment
LTX-109 3% gel, 4 + 2 applicationsDrug
Cohort 2 active treatment
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Vehicle treatment Receives: Drug: Vehicle gel, 4 + 4 applications or 4 + 2 applications |
| Cohort 1 | Active comparator | For all subjects, the IMP was applied 4 times during an intensive dosing regimen for 4 ½-hours (on Day 1 at 0, 1 ½, 3 and 4 ½ - hours). For subjects in Cohort 1, this was followed by 4 additional applications: on Day 1 at 12 hours, on Day 2 at 24 and 36 hours, and on Day 3 at 48 hours. Receives: Drug: LTX-109 3% gel, 4 + 4 applications |
| Cohort 2 | Active comparator | For all subjects, the IMP was applied 4 times during an intensive dosing regimen for 4 ½-hours (on Day 1 at 0, 1 ½, 3 and 4 ½ - hours). For subjects in Cohort 2 the IMP was likewise applied 4 times during the 4 ½-hour period (on Day 1 at 0, 1 ½, 3 and 4½ hours), but was followed by 2 applications: on Day 1 at 12 hours and on Day 2 at 36 hours. Receives: Drug: LTX-109 3% gel, 4 + 2 applications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating Window Eradication
Number of subjects on LTX-109 versus placebo with bacterial eradication period lasting for 6 hours, from 6 to 12 hours after start of treatment (the "Operation Window").
Measured: 6 hour to 12 hours after start of treatment
Secondary outcomes (8)
Number eradicated at specific timepoints
Number of subjects on LTX-109 versus placebo with bacterial eradication at 4 ½, 6 and 12 hours after start of treatment.
Measured: 4.5 hours, 6 hours, 12 hours
Percentage change in colony forming units (CFUs) in subjects from baseline
Percentage change in colony forming units (CFUs) in subjects from baseline on LTX-109 versus placebo at 4 ½, 6 and 12 hours after start of treatment.
Measured: 4.5 hours, 6 hours, 12 hours
Number of subjects on LTX-109 versus placebo with bacterial eradication period lasting for 48 hours
Number of subjects on LTX-109 versus placebo with bacterial eradication period lasting for 48 hours, from 6 to 54 hours after start of treatment ("48 hours Eradication Window")
Measured: From 6 hours to 54 hours after start of treatment
Adverse events
Occurrence and frequency of adverse events (AEs)
Measured: Through treatment and followup of 7 days
Local tolerability assessed by health care professional
Incidence of local reactions (erythema, swelling and lesions) will be assessed. Each nostril will be evaluated separately and each parameter will be scored using a 4-graded scale (0-3): 0: none,1: mild, 2: moderate, 3: severe
Measured: Pre-dose, 1.5 hours, 4.5 hours, 6 hours, 12, hrs, 54 hours and Day 7
Local tolerability assessed by the subject
Incidence of local reactions (pruritus and discomfort) will be assessed by the subject. Each nostril will be evaluated separately using a visual analogue scale (VAS).
Measured: Pre-dose, 1.5 hours, 4.5 hours, 6 hours, 12, hrs, 54 hours and Day 7
Asessment of Vital Signs (Systolic and diastolic blood pressure and pulse)
Systolic and diastolic blood pressure (BP) and pulse will be measured in supine position after 10 minutes of rest
Measured: 24 hours, 54 hours and Day 7
Safety laboratory assessments
Blood samples for the analysis of clinical chemistry and haematology be collected through venepuncture or an indwelling venous catheter and sent to the certified clinical chemistry laboratory and analysed by routine analytical methods. Safety laboratory values will be specified and documented as normal, abnormal NCS, or abnormal CS in the eCRF. Abnormal values assessed by the Investigator as CS will be reported as AEs. Clinical chemistry parameters to be reported: Alanine aminotransferase (ALT),Albumin, Alkaline, phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin (total and conjugated), Calcium, Creatinine (eGFR included), Glucose, Phosphate, Potassium, Sodium, Urea. Haematology parameters to be reported: Red blood cell (RBC) count, White blood cell (WBC) count with differential count, Haematocrit (B-EVF), Haemoglobin (Hb), Platelet count.
Measured: 54 hours and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start19 Sep 2022
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Decolonization of Staphylococcus AureusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, Double-blind, Placebo-controlled Randomization 2:1, active to placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharma Holdings AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Johan Nilsson, MD, Phd, Principal investigator, ClinSmart AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889351
- Sponsor's protocol ID
- C22-109-08
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of 3% LTX-109 Compared to Placebo for Nasal Decolonisation of Staphylococcus Aureus.
- ClinicalTrials.gov ID
- NCT05889351
- Acronym / sponsor ID
- C22-109-08
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Pharma Holdings ASIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 5 Jun 2023 (actual)
- 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.
A Phase IIa, double-blind, placebo-controlled, randomised study designed to evaluate the efficacy, safety and tolerability of two dosing regimens with LTX-109 administered topically to the anterior nares in subjects with persistent carriage of Staphylococcus aureus (S. aureus).
Detailed description
Approximately 90 subjects planned screened to achieve 27 randomised and dosed subjects with persistent S. aureus carriage.
On Day 1, subject randomisation in a 2:1 ratio to receive either LTX-109 (n=18) or placebo (n=9). Cohort (1 [8 doses] or 2 [6 doses]) used as a stratification variable to preserve the 2:1 treatment randomisation ratio in each cohort (LTX-109 n=9 or placebo n=5/4).
For all subjects, the IMP was to be applied 4 times during an intensive dosing regimen for 4 ½-hours (on Day 1 at 0, 1 ½, 3 and 4 ½ - hours). For subjects in Cohort 1, this was followed by 4 additional applications: on Day 1 at 12 hours, on Day 2 at 24 and 36 hours, and on Day 3 at 48 hours. For subjects in Cohort 2 the IMP was likewise applied 4 times during the 4 ½-hour period (on Day 1 at 0, 1 ½, 3 and 4½ hours), but was followed by 2 applications: on Day 1 at 12 hours and on Day 2 at 36 hours. On each dosing occasion, a large drop (approximately 250 μL) of IMP was applied into each nostril and distributed to cover the whole area of the nostril. The subjects were carefully monitored by clinical staff during and after dosing. Safety assessments (AEs, vital signs, safety laboratory assessments and local tolerability) and efficacy assessments (nasal swab) were performed.
All subjects were instructed to wash the body and hair with chlorhexidine body wash and shampoo at the CRU on Day 1 (prior to the first dose) and on Day 2. Subjects were provided with chlorhexidine body wash and shampoo for body and hair wash at home on Day 3, Day 4, Day 5, Day 6 and Day 7. On Day 3 and Day 7, subjects used the chlorhexidine shower before the visits to the CRU.
A final end-of-study visit (Visit 5) took place on Day 7 (+2 days) or after early withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomised, Double-blind, Placebo-controlled Randomization 2:1, active to placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Vehicle gel, 4 + 4 applications or 4 + 2 applicationsVehicle treatment |
| Cohort 1 | Active comparator | Drug: LTX-109 3% gel, 4 + 4 applicationsFor all subjects, the IMP was applied 4 times during an intensive dosing regimen for 4 ½-hours (on Day 1 at 0, 1 ½, 3 and 4 ½ - hours). For subjects in Cohort 1, this was followed by 4 additional applications: on Day 1 at 12 hours, on Day 2 at 24 and 36 hours, and on Day 3 at 48 hours. |
| Cohort 2 | Active comparator | Drug: LTX-109 3% gel, 4 + 2 applicationsFor all subjects, the IMP was applied 4 times during an intensive dosing regimen for 4 ½-hours (on Day 1 at 0, 1 ½, 3 and 4 ½ - hours). For subjects in Cohort 2 the IMP was likewise applied 4 times during the 4 ½-hour period (on Day 1 at 0, 1 ½, 3 and 4½ hours), but was followed by 2 applications: on Day 1 at 12 hours and on Day 2 at 36 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to give written informed consent for participation in the study.
- Male or female subject aged 18 to 65 years, inclusive.
- Persistent nasal carrier of S. aureus (MSSA), confirmed by 2 positive bacterial cultures from the nose during the screening period.
- Medically healthy subjects without abnormal clinically significant medical history, physical findings, vital signs, or laboratory values at the time of screening, as judged by the Investigator.
- Women of child bearing potential (WOCBP) had to practice abstinence (only allowed when this was the preferred and usual lifestyle of the subject) or had to agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy from the date of dosing until 2 weeks after last dose. Female subjects had to refrain from donating eggs from the date of dosing until 3 months after dosing with the IMP. Their male partner had to agree to use a condom from date of first dosing until 2 weeks after last dose if he had not undergone vasectomy.
Key exclusion criteria (13 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, could either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
- Severe eczema or skin wounds, dry or sensitive skin assessed as clinically significant by the Investigator.
- Any positive result at screening for serum hepatitis B surface antigen, hepatitis C antibody and HIV.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to LTX-109 or chlorhexidine.
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 |
|---|---|---|
| Vehicle gel, 4 + 4 applications or 4 + 2 applicationsControl arm/placebo | Drug | Placebo |
| LTX-109 3% gel, 4 + 4 applicationsCohort 1 active treatment | Drug | Cohort 1 |
| LTX-109 3% gel, 4 + 2 applicationsCohort 2 active treatment | Drug | Cohort 2 |
Primary outcome
Operating Window Eradication
Time frame: 6 hour to 12 hours after start of treatment
Number of subjects on LTX-109 versus placebo with bacterial eradication period lasting for 6 hours, from 6 to 12 hours after start of treatment (the "Operation Window").
8 secondary outcomes
Number eradicated at specific timepoints
Time frame: 4.5 hours, 6 hours, 12 hours
Percentage change in colony forming units (CFUs) in subjects from baseline
Time frame: 4.5 hours, 6 hours, 12 hours
Number of subjects on LTX-109 versus placebo with bacterial eradication period lasting for 48 hours
Time frame: From 6 hours to 54 hours after start of treatment
Adverse events
Time frame: Through treatment and followup of 7 days
Local tolerability assessed by health care professional
Time frame: Pre-dose, 1.5 hours, 4.5 hours, 6 hours, 12, hrs, 54 hours and Day 7
Local tolerability assessed by the subject
Time frame: Pre-dose, 1.5 hours, 4.5 hours, 6 hours, 12, hrs, 54 hours and Day 7
Asessment of Vital Signs (Systolic and diastolic blood pressure and pulse)
Time frame: 24 hours, 54 hours and Day 7
Safety laboratory assessments
Time frame: 54 hours and Day 7
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 5 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Johan Nilsson, MD, Phd principal investigator
ClinSmart AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LTX-109 3% gel, 4 + 4 applications and LTX-109 3% gel, 4 + 2 applications in people with Nasal Decolonization of Staphylococcus Aureus, run by Pharma Holdings 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 6 inclusion and 13 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 5 Jun 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Operating Window Eradication (time frame: 6 hour to 12 hours after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2023.