Development of a standard method for measurement of azithromycin concentration in vaginal cellular material – a pilot study

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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.

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