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
Alfred Hospital
55 Commercial Rd, Melbourne VIC 3004
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
There are increasing concerns regarding the treatment efficacy of azithromycin 1g single dose for the treatment of rectal chlamydia infections with treatment failure rates up to 21% being reported.

There is no pharmacokinetic data available to determine if low rectal tissue concentrations contribute to treatment failure.

The purpose of this study is to provide the world first evidence of the pharmacokinetics of azithromycin 1g in rectal tissue
Trial website
NIL
Trial related presentations / publications
NIL
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
Prof 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
Prof 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.