Study of the Nasal Decolonisation of Staphylococcus Aureus (SA) and the Safety and Tolerability of XF-73 Nasal Gel in Healthy Subjects

NCT02282605 | Completed Phase 1 Results

• 1 other identifier: XF-73B03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Staphylococcus Aureus Infection

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  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

  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

  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.

  Assessed over the two day treatment period and follow-up at 7 and 14 days relative to the first dose.

Study Arms (3)

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.

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.

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.

Drug: Placebo nasal gel; Other: Chlorhexidine gluconate 2% topical cloths

Interventions

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

Eligibility Criteria

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

You may qualify if:

• Normal, healthy male or female subjects aged between 18 and 75 years.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Destiny Pharma Plc: lead

Study Sites (1)

Quintiles Drug Research Unit

London, SE11 1YR, United Kingdom

Location

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

chlorhexidine gluconate; Textiles

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Director of Projects
• Organization: Destiny Pharma

medinfo@destinypharma.com

+44 (0) 1273 704440

Study Officials

• Ian Mr Hayter, BSc

  Destiny Pharma Plc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 4, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 7, 2016
• Results First Posted: October 7, 2016

Record last verified: 2016-06

Locations

GB (1)