Impact of antibiotic treatment regimen on sexual behaviour following urogenital Chlamydia trachomatis infection

Impact of antibiotic treatment regimen (azithromycin 1g single dose vs doxycycline 100mg twice daily for 7 days) on sexual behavior following urogenital Chlamydia trachomatis infection among heterosexuals – an open label randomised controlled trial

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001584426

Acronym

NIL

Enrollment

200

Registered

2016-11-16

Start date

2017-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Azithromycin and doxycycline are antibiotics that are widely used in the management of sexually transmissible infections (STIs). STI management guidelines in Australia, the UK and US all recommend the use of azithromycin (1g single dose, orally) or doxycycline (100mg, orally, twice daily for 7 days) for uncomplicated urogenital chlamydia with the former preferred for its ease of dose and minimalisation of non-adherence. The most recent meta-analysis shows that the regimens are comparable with only a marginal increase (3%) in efficacy in favour of doxycycline over azithromycin. However, it has been hypothesised that treatment regimen may influence patient’s sexual behavior, placing them at increased risk of early re-infection. Patients on doxycycline – a 7-day daily regimen, may be more mindful of their infection status because they need to take a daily dose and may not re-engage in unprotected sex until dosage is completed. On the other hand, those on single dose regimens may feel more confident that their condition has been treated or may forget about their infection and may re-engage in sexual activity earlier than those taking doxycycline, potentially making them more at risk of re-infection. To our knowledge, this has never been formally studied and represents a knowledge gap in the literature, necessitating this study.

Interventions

Azithromycin (1g single dose, oral tablet) to be taken under observation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

Heterosexual patients diagnosed positive for asymptomatic urogential chlamydia by nucleic acid amplification test. Adequate English and comprehension skills to give consent Willing and able to answer to survey questions by SMS.

Exclusion criteria

Patients will be excluced if they are: they are concurrently diagnosed with another bacterial STI; have known contraindications to trial medications; present with symptomatic urethritis or pelvic inflammatory disease; are currently engaged in commercial sex work; or are pregnant.

Outcome results