ANZCTR - Registration

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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]

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

Condition category

Condition code

Infection

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Vaginal tissue concentrations of azithromycin (mcg/g) post-dose using self-collected vaginal swabs and measured with liquid-chromatography tandem-mass spectrometry

Timepoint [1]

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]

Blood concentrations of azithromycin (mcg/ml) post-dose measured with liquid-chromatography tandem-mass spectrometry

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3053 - Carlton

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Research Committee Secretariat NHMRC GPO Box 1421 Canberra ACT 2601

Country [1]

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]

None

Name [1]

NIL

Address [1]

NIL

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health Human Ethics Committee

Ethics committee address [1]

Alfred Hospital
55 Commercial Rd, Melbourne VIC 300

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/12/2011

Approval date [1]

10/04/2012

Ethics approval number [1]

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

Prof Jane Hocking

Address

University of Melbourne
Level 3, 207 Bouverie st
Carlton South 3053
Victoria, Australia

Country

Australia

Phone

+61 3 8344 0762

Fax

+61 3 9349 5815

jhocking@unimelb.edu.au

Contact person for public queries

Name

Jane Hocking

Address

University of Melbourne
Level 3, 207 Bouverie st
Carlton South 3053
Victoria, Australia

Country

Australia

Phone

+61 3 8344 0762

Fax

jhocking@unimelb.edu.au

Contact person for scientific queries

Name

Jane Hocking

Address

University of Melbourne
Level 3, 207 Bouverie st
Carlton South 3053
Victoria, Australia

Country

Australia

Phone

+61 3 8344 0762

Fax

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

Source	Title	Year of Publication	DOI
Embase	Measurement of tissue azithromycin levels in self-collected vaginal swabs post treatment using liquid chromatography and tandem mass spectrometry (LC-MS/MS).	2017	https://dx.doi.org/10.1371/journal.pone.0177615

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically