Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001666415
Ethics application status
Approved
Date submitted
29/11/2016
Date registered
2/12/2016
Date last updated
2/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pharmacokinetics of azithromycin 1 gram single dose in anorectal tissue and serum
Scientific title
Pharmacokinetics of azithromycin 1 gram single dose in anorectal tissue and serum in healthy men
Secondary ID [1] 290637 0
None
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record
NIL

Health condition
Health condition(s) or problem(s) studied:
rectal chlamydia 301159 0
Condition category
Condition code
Infection 300924 300924 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Azithromycin 1g single dose (oral tablet), with food by direct observation.
Intervention code [1] 296522 0
Treatment: Drugs
Comparator / control treatment
NIL
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300340 0
Anorectal tissue sample concentrations (mcg/g) of azithromycin post-dose
Timepoint [1] 300340 0
Baseline (pre-dose), 2 hours, 24 hours and days 2,3,4,7,10 and 14 post dose
Primary outcome [2] 300383 0
Blood concentration (mcg/mL) post azithromycin dose
Timepoint [2] 300383 0
2 hours post-dose
Secondary outcome [1] 329856 0
NIL
Timepoint [1] 329856 0
NIL

Eligibility
Key inclusion criteria
- Men who are HIV/STI free and chlamydia negative
- Men aged 18 years and over
- Adequate English and comprehension skills to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Self-report of antibiotic use in the last 2 weeks
- Current commercial sex work
- Men who do not have a mobile phone
- HIV positive status
- Concurrent medication likely to significantly interact with azithromycin (e.g. cyclosporine, digoxin)
- Known macrolide allergy or contraindications

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NIL
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NIL
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NIL
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis
Descriptive and pharmacokinetic analysis of azithromycin concentrations in tissue and blood

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
31/03/2016
Date of last data collection
Anticipated
Actual
30/04/2016
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 14734 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 295073 0
University
Name [1] 295073 0
University of Melbourne
Country [1] 295073 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Level 3, 207 Bouverie st
Carlton South, Victoria, 3053
Country
Australia
Secondary sponsor category [1] 293883 0
None
Name [1] 293883 0
NIL
Address [1] 293883 0
NIL
Country [1] 293883 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296418 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 296418 0
Ethics committee country [1] 296418 0
Australia
Date submitted for ethics approval [1] 296418 0
22/05/2015
Approval date [1] 296418 0
02/07/2015
Ethics approval number [1] 296418 0
267/15

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70810 0
Prof Jane Hocking
Address 70810 0
University of Melbourne
Level 3, 207 Bouverie st
Carlton South 3053
Victoria, Australia
Country 70810 0
Australia
Phone 70810 0
+61 3 8344 0762
Fax 70810 0
+61 3 9349 5815
Email 70810 0
[email protected]
Contact person for public queries
Name 70811 0
Jane Hocking
Address 70811 0
University of Melbourne
Level 3, 207 Bouverie st
Carlton South 3053
Victoria, Australia
Country 70811 0
Australia
Phone 70811 0
+61 3 8344 0762
Fax 70811 0
+61 3 9349 5815
Email 70811 0
[email protected]
Contact person for scientific queries
Name 70812 0
Jane Hocking
Address 70812 0
University of Melbourne
Level 3, 207 Bouverie st
Carlton South 3053
Victoria, Australia
Country 70812 0
Australia
Phone 70812 0
+61 3 8344 0762
Fax 70812 0
+61 3 9349 5815
Email 70812 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbasePharmacokinetics of a single 1g dose of azithromycin in rectal tissue in men.2017https://dx.doi.org/10.1371/journal.pone.0174372
N.B. These documents automatically identified may not have been verified by the study sponsor.