Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000267459
Ethics application status
Approved
Date submitted
12/05/2007
Date registered
18/05/2007
Date last updated
21/11/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1/2, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Topical Antimicrobial (NEO101) in the Reduction or Eradication of Staphylococcus aureus Nasal Carriage among Adults
Scientific title
A Phase 1/2, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Topical Antimicrobial (NEO101) in the Reduction or Eradication of Staphylococcus aureus Nasal Carriage among Adults
Secondary ID [1] 367 0
Therapeutic Goods Association Clinical Trial Notification (TGA CTN): TGA CTN - 2007/246 (issued on 03/05/07)
Universal Trial Number (UTN)
Trial acronym
NEO101-CLIN-N001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stable nasal carriage of Staphylococcus aureus in adults 1807 0
Condition category
Condition code
Infection 1895 1895 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible subjects will receive either 0.95% NEO101, which will be administered twice daily by topical application to the inside of each nostril, for a 7-day treatment course. A 14-day safety and efficacy assessment period will follow the treatment period.
Intervention code [1] 1754 0
Treatment: Drugs
Comparator / control treatment
Vehicle-containing placebo only.
Control group
Placebo

Outcomes
Primary outcome [1] 2694 0
The primary objective of this study is to evaluate the safety and local tolerability of twice-daily topical nasal application of NEO101 in adult subjects with stable nasal carriage of Staphylococcus aureus.
Timepoint [1] 2694 0
Safety and local tolerability will be assessed during the 7-day treatment course and through the 14-day follow-up period. Assessments will be made on a daily basis.
Secondary outcome [1] 4558 0
1) to make a preliminary evaluation of the efficacy of twice-daily topical nasal application of NEO101 in the reduction or eradication of nasal carriage of S. aureus;
Timepoint [1] 4558 0
These evaluations will be based on quantitative microbiologic determinations of S. aureus before, during and after treatment. Cultures for S. aureus will be performed during screening and on Days 1, 2, 3, 5, 7, 8, 10, 15 and 22.
Secondary outcome [2] 4559 0
2) to make a preliminary evaluation of the efficacy of NEO101 in the reduction or eradication of specific strains of S. aureus, including methicillin-sensitive and methicillin-resistant (MRSA) strains.
Timepoint [2] 4559 0
These evaluations will be based on quantitative microbiologic determinations of S. aureus before, during and after treatment. Cultures for S. aureus will be performed during screening and on Days 1, 2, 3, 5, 7, 8, 10, 15 and 22.

Eligibility
Key inclusion criteria
Subjects in general good health, have nasal cultures positive for S. aureus, are compliant with (defined) birth control.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug, have clinical evidence of active cutaneous infection, have had skin or soft tissue infection with S. aureus within 30 days prior to randomization, have documented disruption of the nasal or facial bones, have atopic dermatitis/eczema, allergic rhinitis, nasal polyps, or nasal piercings, have a history of hypersensitivity or allergic reaction to parabens, sodium sulfite or any other ingredient in the vehicle formulation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be randomized to receive either NEO101 or vehicle-containing placebo. Each subject will be assigned a unique subject number, corresponding to the randomization code indicating treatment group. The study site is supplied with blinded numbered study drug kits. Allocation is concealed by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomized to treatment using the order established on the drug dispensation list. The randomization schedule was developed using a blocked randomization scheme.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The investigator (responsible for administration of treatment and assessment of response), study staff (supporting the investigator and sponsor in collection and reporting of response) and subjects will be blinded.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2041 0
Commercial sector/Industry
Name [1] 2041 0
Neosil, Inc.
Country [1] 2041 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Neosil, Inc.
Country
United States of America
Secondary sponsor category [1] 1849 0
None
Name [1] 1849 0
not applicable
Country [1] 1849 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3778 0
Q-Pharm Pty Ltd, Clive Berghofer Cancer Research Center-Queensland Institute of Medical Research Human Research Ethics Committee
Ethics committee address [1] 3778 0
Ethics committee country [1] 3778 0
Australia
Date submitted for ethics approval [1] 3778 0
Approval date [1] 3778 0
03/05/2007
Ethics approval number [1] 3778 0
2007/246

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 27857 0
Address 27857 0
Country 27857 0
Phone 27857 0
Fax 27857 0
Email 27857 0
Contact person for public queries
Name 10943 0
Suzanne Elliott, Operations Manager
Address 10943 0
Q-Pharm Pty Ltd PO Box 78 Royal Brisbane Hospital Brisbane QLD 4029
Country 10943 0
Australia
Phone 10943 0
+61 7 38453644
Fax 10943 0
+61 7 38453637
Email 10943 0
s.elliott@qpharm.com.au
Contact person for scientific queries
Name 1871 0
Andria Langenberg, MD
Address 1871 0
Neosil, Inc. 5980 Horton Street, Suite 525 Emeryville, California 94608
Country 1871 0
United States of America
Phone 1871 0
+1 510 5473610 ext. 180
Fax 1871 0
+1 510 5473604
Email 1871 0
andria.langenberg@neosil.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.