Staphylococcus Aureus InfectionPhase 1/2NCT02282605
Study of the Nasal Decolonisation of Staphylococcus Aureus (SA) and the Safety and Tolerability of XF-73 Nasal Gel in Healthy Subjects
A Phase 1/2 study testing XF-73 nasal gel and Chlorhexidine gluconate 2% topical cloths in people with Staphylococcus Aureus Infection, run by Destiny Pharma Plc at 1 site in United Kingdom.
Trial summary
Study to determine the efficacy, safety and tolerability of two concentrations of XF-73 nasal gel in combination with body and face washing with chlorhexidine gluconate cloths in eradicating nasal carriage of Staphylococcus aureus. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus Infection
- What is being tested?
- XF-73 nasal gel and Chlorhexidine gluconate 2% topical cloths
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Nov 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal, healthy male or female subjects aged between 18 and 75 years.
- Subjects confirmed to be persistent nasal SA carriers, defined by 3 separate, SA positive cultures from nasal swabs. Two positive cultures should be obtained at screening visits up to 12 weeks prior to inclusion and at least two weeks apart. The final confirmatory culture should be obtained from a nasal swab on the day of admission to the unit (day -1). Note: Dosing with XF-73 may commence before the result of the day -1 swab is obtained. If the result is negative, the subject should be withdrawn.
- Subjects who are able and willing to provide written informed consent to participate in the study
- Subjects who have a body mass index (BMI) ≥18.5 kg/m2 and ≤ 32kg/m2.
- Subjects who agree not to take part in another clinical trial at any time during the study period.
Who cannot join
- Female subjects who are or may be pregnant or who are lactating.
- Subjects who have any acute or chronic illness or infection.
- Subjects who have smoked within the 3 months prior to screening.
- Subjects who are females of child-bearing potential, defined as being physiologically capable of becoming pregnant, UNLESS using one or more of the following acceptable methods of contraception; established use of oral, injected or implanted hormonal contraception, intrauterine Device (IUD or Coil AND barrier Method (condom or diaphragm or cervical/vault cap) plus spermicidal cream/gel. Contraceptive use should continue throughout the study and for 1 month following completion of the study.
- Subjects who are fertile males, defined as all males physiologically capable of conceiving offspring, UNLESS the subject agrees to comply with acceptable contraception e.g. condom plus spermicidal cream/gel. Contraceptive use should continue throughout the study and for 3 months following completion of the study.
- Subject with any open wound, lesion, inflammation, erythema or infection affecting the nostrils, nose, upper lip and area of skin close to the nose. This includes herpes simplex lesions and discoid lupus.
Show all 26Show fewer
- Subjects who have a currently symptomatic upper respiratory tract infection, nasopharyngitis, influenza or condition involving increase in nasal secretion such as seasonal or chronic, allergic rhinitis.
- Subjects with a history of drug or alcohol abuse in the previous 12 months or who have a positive urine drug test for substances of abuse.
- Subjects with a known clinically significant history of atopy or hypersensitivity to any drug or latex.
- Subjects with a history of serious illness, cancer or psychiatric condition.
- Subjects with known skin photosensitivity.
- Subjects with a personal or family history of porphyria.
- Subjects who have been treated with or have taken any prescribed or over-the-counter medication within the 14 days prior to admission, with the exception of hormonal contraceptives or hormone replacement therapy.
- Subjects who have taken or used topical or systemic antibiotics within the month prior to screening.
- Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for human immunodeficiency virus (HIV) antibodies
- Subjects who have participated in a clinical trial within the last 3 months.
- Subjects who have been exposed to XF-73 as part of a previous clinical trial.
- Subjects with any clinically significant abnormality in vital signs or laboratory analyses at screening or at baseline, based on the opinion of the investigator.
- Subjects with nasal polyps or significant anatomical nasal abnormality.
- Subjects with a history of nasal surgery, including cauterization in the last 12 months.
- Subjects with a history of multiple episodes [>3] of epistaxis within the last 12 months.
- Subjects known to have dermal sensitivity to benzalkonium chloride or other quaternary ammonium disinfectants.
- Subjects with in-situ nasal jewellery or open nasal piercings.
- Subjects known to have dermal sensitivity to chlorhexidine gluconate (CHG).
- Subjects with a history of abnormal bleeding, bruising, frequent nosebleeds or a diagnosis of von Willebrand disease.
- Subjects who have or have had an autoimmune disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Randomised, Double-blind, Placebo-controlled, Single Centre Study of the Nasal Decolonisation of Staphylococcus Aureus (SA) and the Safety and Tolerability of Two Concentrations of XF-73 Nasal Gel in Healthy Subjects.
Study to determine the efficacy, safety and tolerability of two concentrations of XF-73 nasal gel in combination with body and face washing with chlorhexidine gluconate cloths in eradicating nasal carriage of Staphylococcus aureus.
- Conditions
- Staphylococcus Aureus Infection
- Being tested
- XF-73 nasal gel, Placebo nasal gel, Chlorhexidine gluconate 2% topical cloths
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XF-73 nasal gelDrug
Placebo nasal gelDrug
Chlorhexidine gluconate 2% topical clothsOther
| Study group | Role | What they receive |
|---|---|---|
| XF-73 2.0 mg/g nasal gel | Experimental | 0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths. Receives: Drug: XF-73 nasal gel; Other: Chlorhexidine gluconate 2% topical cloths |
| XF-73 0.5 mg/g nasal gel | Experimental | 0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths. Receives: Drug: XF-73 nasal gel; Other: Chlorhexidine gluconate 2% topical cloths |
| Placebo nasal gel | Placebo comparator | 0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths. Receives: Drug: Placebo nasal gel; Other: Chlorhexidine gluconate 2% topical cloths |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.
Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).
Measured: The primary endpoint was 48 hours after the last dose (Day 4, 84 hours).
Secondary outcomes (4)
Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.
Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).
Measured: Time-points: Day 1(12 hours), Day 2 (24 hours), Day 3 (12 hours after last dose), Day 7 and Day 14.
Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score
The number of subjects with absence of SA from nasal swabs at the specified time-points..
Measured: Day 1 (12 h), Day 2 (24 h) , Day 3 (12 hours after last dose),Day 4 (48 hours after last dose)
AUC of the Semi-quantitative SA Scores From Nasal Swabs
Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Mean changes from baseline (0h) to each timepoint (Day 1,12 h; Day 2, 24 h: Day 3, 48h; Day 4, 84h; Day 7, 144h; Day 14, 312h) were calculated by treatment for the semi-quantitative SA scores. The AUC of the semi-quantitative SA scores were calculated for the two-day treatment period (AUC Day1- Day2); through the two day treatment period and up to discharge (AUC Day 1- Day4); and over the two-day treatment period, discharge and follow-up (AUC Day1- Day14). AUC was calculated by means of a trapezoidal rule using a standard algorithm. A higher AUC is indicative of a higher bacterial growth.
Measured: 2 day treatment period; 2 day treatment period up to discharge; 2 day treatment period, discharge and follow-up
The Number of Participants With Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests.
Measured: Assessed over the two day treatment period and follow-up at 7 and 14 days relative to the first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Staphylococcus Aureus InfectionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Destiny Pharma Plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian Mr Hayter, BSc, Study director, Destiny Pharma Plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282605
- Sponsor's protocol ID
- XF-73B03
- Status last verified
- Jun 2016
- First submitted
- 21 Oct 2014
- Last updated
- 7 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomised, Double-blind, Placebo-controlled, Single Centre Study of the Nasal Decolonisation of Staphylococcus Aureus (SA) and the Safety and Tolerability of Two Concentrations of XF-73 Nasal Gel in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT02282605
- Acronym / sponsor ID
- XF-73B03
- Conditions
- Staphylococcus Aureus Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Destiny Pharma PlcIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Posted 7 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to determine the efficacy, safety and tolerability of two concentrations of XF-73 nasal gel in combination with body and face washing with chlorhexidine gluconate cloths in eradicating nasal carriage of Staphylococcus aureus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XF-73 2.0 mg/g nasal gel | Experimental | Drug: XF-73 nasal gel, Other: Chlorhexidine gluconate 2% topical cloths0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths. |
| XF-73 0.5 mg/g nasal gel | Experimental | Drug: XF-73 nasal gel, Other: Chlorhexidine gluconate 2% topical cloths0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths. |
| Placebo nasal gel | Placebo comparator | Drug: Placebo nasal gel, Other: Chlorhexidine gluconate 2% topical cloths0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Normal, healthy male or female subjects aged between 18 and 75 years.
- Subjects confirmed to be persistent nasal SA carriers, defined by 3 separate, SA positive cultures from nasal swabs. Two positive cultures should be obtained at screening visits up to 12 weeks prior to inclusion and at least two weeks apart. The final confirmatory culture should be obtained from a nasal swab on the day of admission to the unit (day -1). Note: Dosing with XF-73 may commence before the result of the day -1 swab is obtained. If the result is negative, the subject should be withdrawn.
- Subjects who are able and willing to provide written informed consent to participate in the study
- Subjects who have a body mass index (BMI) ≥18.5 kg/m2 and ≤ 32kg/m2.
- Subjects who agree not to take part in another clinical trial at any time during the study period.
Key exclusion criteria (26 listed)
- Female subjects who are or may be pregnant or who are lactating.
- Subjects who have any acute or chronic illness or infection.
- Subjects who have smoked within the 3 months prior to screening.
- Subjects who are females of child-bearing potential, defined as being physiologically capable of becoming pregnant, UNLESS using one or more of the following acceptable methods of contraception; established use of oral, injected or implanted hormonal contraception, intrauterine Device (IUD or Coil AND barrier Method (condom or diaphragm or cervical/vault cap) plus spermicidal cream/gel. Contraceptive use should continue throughout the study and for 1 month following completion of the study.
- Subjects who are fertile males, defined as all males physiologically capable of conceiving offspring, UNLESS the subject agrees to comply with acceptable contraception e.g. condom plus spermicidal cream/gel. Contraceptive use should continue throughout the study and for 3 months following completion of the study.
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 |
|---|---|---|
| XF-73 nasal gel | Drug | XF-73 0.5 mg/g nasal gel, XF-73 2.0 mg/g nasal gel |
| Placebo nasal gel | Drug | Placebo nasal gel |
| Chlorhexidine gluconate 2% topical cloths | Other | Placebo nasal gel, XF-73 0.5 mg/g nasal gel, XF-73 2.0 mg/g nasal gel |
Primary outcome
Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.
Time frame: The primary endpoint was 48 hours after the last dose (Day 4, 84 hours).
Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).
4 secondary outcomes
Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.
Time frame: Time-points: Day 1(12 hours), Day 2 (24 hours), Day 3 (12 hours after last dose), Day 7 and Day 14.
Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score
Time frame: Day 1 (12 h), Day 2 (24 h) , Day 3 (12 hours after last dose),Day 4 (48 hours after last dose)
AUC of the Semi-quantitative SA Scores From Nasal Swabs
Time frame: 2 day treatment period; 2 day treatment period up to discharge; 2 day treatment period, discharge and follow-up
The Number of Participants With Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests.
Time frame: Assessed over the two day treatment period and follow-up at 7 and 14 days relative to the first dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Staphylococcus Aureus Infection
RecruitingObservational study
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Bacteria Infection Mechanism
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
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.
Ian Mr Hayter, BSc study director
Destiny Pharma Plc
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 XF-73 nasal gel and Chlorhexidine gluconate 2% topical cloths in people with Staphylococcus Aureus Infection, run by Destiny Pharma Plc at 1 site in United Kingdom.
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 5 inclusion and 26 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 7 Oct 2016. 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 United Kingdom. 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 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?
Yes. Results are posted in the registry (first posted 7 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method. (time frame: The primary endpoint was 48 hours after the last dose (Day 4, 84 hours).). 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 7 Oct 2016.