Vaginal Infection Clinical Trial
Official title:
Randomized, Open-label, Multicenter Study of Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection
Chlamydia trachomatis is the most commonly reported bacterial sexually transmitted infection
(STI), especially among young women. Up to 75% of C. trachomatis infected women are
asymptomatic. If untreated, C. trachomatis infection can cause sequelae such as pelvic
inflammatory disease, ectopic pregnancy and tubal factor infertility. C. trachomatis can also
cause anorectal infections, which are typically asymptomatic. Among women with urogenital
chlamydial infection, around 36-91% also had concurrent anorectal chlamydial. Notably, there
was no association with anal intercourse in the studies that reported it. However, guidelines
do not recommend routine anorectal testing, but restricted testing in people who are in
high-risk groups, report anal sexual behavior, or have anal symptoms, i.e., on selective
indications. This is in contrast to urogenital testing, which is a routine procedure in STI
care services.
The anal transmission of C. trachomatis in women may occur by autoinoculation from the vagina
due to the close proximity of the vagina and the anus. C. trachomatis could lead to a
persistent infection in the lower gastrointestinal tract, suggesting the potential role of
autoinoculation of cervical chlamydial infection from the rectal site. Such (repeat)
urogenital infections could lead to reproductive tract morbidity. Recommended treatments for
C. trachomatis infections are a single 1g dose of azithromycin or 100mg of doxycycline 2
times a day for 7 days. Although these two regimens are equivalent for urogenital infection,
no study has compared the effectiveness of these two treatments on anorectal infection. If
rectal C. trachomatis is a hidden reservoir influencing transmission rates, and considering
the potential complications of cervical infections, providing further evidence of the need
for effective rectal treatments among women is highly relevant.
A possible reason for C. trachomatis detection after treatment may be transmission (self or
another) or treatment failure. Whether antimicrobial treatment failure for C. trachomatis
plays a role remains poorly understood. There is no evidence of antimicrobial resistance and
testing for antimicrobial resistance for C. trachomatis is not routinely available. The
hypothesis of transmission is most likely, especially as recontamination is very common among
young people, either due to an untreated partner or a new partner. When these two conditions
are ruled out, the hypothesis of autoinoculation from rectum to vagina is quite probable.
With regard to anorectal C. trachomatis infections, some studies concluded that azithromycin
is a suboptimal treatment], while another study found doxycycline and azithromycin treatment
to be equally effective. However, there are no robust studies that shows conclusive evidence
relating to a suboptimal effect of any time of treatment or that prefers one treatment over
the other.
The current study attempts to clarify the above question. The team propose to conduct the
first open-label randomized controlled trial comparing the efficacy (measured as microbial
cure) of a single 1g dose of azithromycin versus 100 mg of doxycycline twice daily for seven
days for the treatment of anorectal C. trachomatis infection concurrent to urogenital
infection in women. The experimental group will include women with C. trachomatis-positive
vaginal and anorectal swabs treated with doxycycline twice daily for seven days with one
tablet of 100 mg of doxycycline in the morning and evening. The control group will include
women with C. trachomatis-positive vaginal and anorectal swabs treated with azithromycin
consisting of four tablets of 250 mg of azithromycin in one intake.
The team made the hypothesis that the efficacy of azithromycin for anorectal infections may
be lower than that of doxycycline, resulting in reinfections by autoinoculation from rectum
to vagina. The expected result is that the number of women with a C. trachomatis-positive
NAAT result in the anorectal swab will be significantly higher in the control group than in
the experimental group after treatment.
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