Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001684415
Ethics application status
Approved
Date submitted
5/12/2016
Date registered
7/12/2016
Date last updated
7/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of a standard method for measurement of azithromycin concentration in vaginal cellular material – a pilot study
Scientific title
Measurement of tissue azithromycin levels in self-collected vaginal swabs post treatment using liquid chromatography and tandem mass spectrometry (LC-MS/MS)
Secondary ID [1] 290683 0
none
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record
NIL

Health condition
Health condition(s) or problem(s) studied:
genital chlamydia infection 301219 0
Condition category
Condition code
Infection 300977 300977 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] 296567 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300403 0
Vaginal tissue concentrations of azithromycin (mcg/g) post-dose using self-collected vaginal swabs and measured with liquid-chromatography tandem-mass spectrometry
Timepoint [1] 300403 0
Baseline (pre-dose), 1/2 hourly for up to 5 hours, 24 hours and then daily up to 9-days post-dose
Secondary outcome [1] 329890 0
Blood concentrations of azithromycin (mcg/ml) post-dose measured with liquid-chromatography tandem-mass spectrometry
Timepoint [1] 329890 0
4 hours post-dose

Eligibility
Key inclusion criteria
1 Women aged 18 years and older
2 Must have adequate English and comprehension skills to give informed consent.
3 Able to attend the clinic at regular intervals during the study to collect and drop of specimens.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1 Pregnant women
2 Women currently menstruating
3 Women on medication likely to significantly interact with Azithromycin eg. Cyclosporin, digoxin
4 Women known to have any allergies associated with macrolides (very rare).

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
Pharmacokinetics
Statistical methods / analysis
Absorption concentration over time will be monitored for each participant. Correlations with weight and height and medications will be assessed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/07/2012
Date of last participant enrolment
Anticipated
Actual
4/06/2014
Date of last data collection
Anticipated
Actual
27/04/2016
Sample size
Target
30
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 14796 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 295111 0
Government body
Name [1] 295111 0
National Health and Medical Research Council
Country [1] 295111 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] 293930 0
None
Name [1] 293930 0
NIL
Address [1] 293930 0
NIL
Country [1] 293930 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296463 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 296463 0
Alfred Hospital
55 Commercial Rd, Melbourne VIC 300
Ethics committee country [1] 296463 0
Australia
Date submitted for ethics approval [1] 296463 0
22/12/2011
Approval date [1] 296463 0
10/04/2012
Ethics approval number [1] 296463 0
480/11

Summary
Brief summary
There is considerable concern internationally about chlamydia treatment failure. Studies have found that chlamydia treatment failure may be at least 8%, considerably higher than the 2-3% failure expected based on results of previous chlamydia treatment trials that with the exception of one trial, all used the less sensitive culture to measure antimicrobial cure.
A treatment failure rate of 8% rather than 2-3% means a further nearly 3,000 in Australia and 70,000 women in the USA were inadequately treated for chlamydia in 2009, leading to longer duration of infection, increased risk of developing sequelae and continued transmission. It remains uncertain if this treatment failure is because of (1) re-infection by an untreated partner; (2) failure of the drug itself due to poor absorption from the stomach or low concentrations in female genital tissue where it is needed to work (3) the body’s immune system’s inability to fight the infection.

We have received NHMRC funding to conduct a large cohort study of 450 women that aims to estimate azithromycin treatment failure for genital chlamydia infection. In order to understand failure due to (2) above (poor absorption), we propose to develop a test to measure the concentration of the drug in female cervical cellular material. We wish to determine whether azithromycin is present at the cervix in sufficient concentrations to kill chlamydia. This was done by Worm and colleagues in the early 1990s.
The purpose of this study is to develop a test and specimen collection method that measures azithromycin absorption in cervical cellular material (mucus and cells) using a specimen that is practical and acceptable to women – self-collected vaginal swabs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70946 0
Prof Jane Hocking
Address 70946 0
University of Melbourne
Level 3, 207 Bouverie st
Carlton South 3053
Victoria, Australia
Country 70946 0
Australia
Phone 70946 0
+61 3 8344 0762
Fax 70946 0
+61 3 9349 5815
Email 70946 0
jhocking@unimelb.edu.au
Contact person for public queries
Name 70947 0
Prof Jane Hocking
Address 70947 0
University of Melbourne
Level 3, 207 Bouverie st
Carlton South 3053
Victoria, Australia
Country 70947 0
Australia
Phone 70947 0
+61 3 8344 0762
Fax 70947 0
Email 70947 0
jhocking@unimelb.edu.au
Contact person for scientific queries
Name 70948 0
Prof Jane Hocking
Address 70948 0
University of Melbourne
Level 3, 207 Bouverie st
Carlton South 3053
Victoria, Australia
Country 70948 0
Australia
Phone 70948 0
+61 3 8344 0762
Fax 70948 0
Email 70948 0
jhocking@unimelb.edu.au

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
EmbaseMeasurement of tissue azithromycin levels in self-collected vaginal swabs post treatment using liquid chromatography and tandem mass spectrometry (LC-MS/MS).2017https://dx.doi.org/10.1371/journal.pone.0177615
N.B. These documents automatically identified may not have been verified by the study sponsor.