Study to Assess Eradication of Nasal Carriage of Staphylococcus Aureus (SA) With Mupirocin (Bactroban 2% Nasal Ointment)

NCT02284555 | Completed Phase 4 Results

• 1 other identifier: XF-MupC01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the nasal eradication of SA in healthy subjects following treatment with mupirocin 2% (Bactroban 2% Nasal Ointment) twice daily for 5 days, by means of a broth enriched culture microbial assay. The sensitivities of broth enrichment and plating assay methods will be compared. The safety and tolerability of Bactroban 2% Nasal Ointment will also be assessed.

Conditions

Staphylococcal Infection

Outcome Measures

Primary Outcomes (1)

• Apparent Eradication of Nasal Carriage of SA

  Apparent eradication demonstrated by a semi-quantitative score of negative or zero using a broth enriched culture microbial assay.

  48 hours after the last dose of mupirocin 2%

Secondary Outcomes (1)

• The Number of Subjects With Adverse Events and Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests Assessed Over the Five Day Treatment Period and Follow-up at 7 and 14 Days Relative to the First Dose.

  5 day treatment period and follow-up at 7 and 14 days

Study Arms (1)

Mupirocin 2% nasal Ointment

EXPERIMENTAL

Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).

Drug: Mupirocin

Interventions

Mupirocin DRUG

Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC.

Also known as: Bactroban

Mupirocin 2% nasal Ointment

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 ≤ 32 kg/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 (confirmed by urinary cotinine test).
• 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 who have been treated with or have taken any prescribed or over-the-counter medication within the previous 14 days, 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 with any clinically significant abnormality in vital signs or laboratory analyses at screening or at baseline, based on the opinion of the investigator.

Sponsors & Collaborators

• Destiny Pharma Plc: lead

Study Sites (1)

Simbec Reseach Ltd

Wales, CF48 4DR, United Kingdom

Location

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Mupirocin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids

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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 6, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 1, 2016
• Results First Posted: March 1, 2016

Record last verified: 2016-02

Locations

GB (1)