Doxycycline versus azithromycin for the treatment of anorectal Chlamydia trachomatis infection in women concurrent with vaginal infection (CHLAZIDOXY study): a multicentre, open-label, randomised, controlled, superiority trial
Anorectal bacterial infections with Chlamydia trachomatis are normally uncovered in gals. Despite the fact that the efficacy of doxycycline and azithromycin
is equivalent in the cure of urogenital infection, their efficacies towards anorectal
an infection keep on being unclear. We therefore aimed to compare a solitary dose of azithromycin
with a 7-day training course of doxycycline for the cure of anorectal C trachomatis an infection in ladies with concurrent vaginal an infection.
4 sexually transmitted an infection screening centres and three being pregnant termination
centres in France. We integrated sexually active grownup women (≥18 decades) with a optimistic
C trachomatis vaginal swab who agreed to supply self-gathered anorectal swabs for C trachomatis detection. Participants were randomly assigned (1:1), employing block measurements of 6 and
eight and stratification by each and every investigating centre, to orally receive both azithromycin
(a single 1-g dose, with or devoid of foods) or doxycycline (100 mg in the morning and
evening at mealtimes for 7 days [ie, 100 mg of doxycycline twice per day for 7 days]).
All laboratory workers who did the bacteriological analyses, but not the individuals
and the investigators, were being masked to the treatment teams. The major final result was
the microbiological anorectal get rid of price outlined as a C trachomatis-negative nucleic acid amplification take a look at (NAAT) final result in anorectal specimens 6 months
after procedure initiation amid ladies who had a baseline C trachomatis-beneficial anorectal NAAT outcome. The main analysis was carried out in the modified intention-to-treat
populace, with several imputation, which bundled all gals who underwent randomisation
and had a C trachomatis-constructive vaginal and anorectal NAAT final result at baseline. Adverse activities were being claimed
in all females who underwent randomisation. This study is registered with ClinicalTrials.gov, variety NCT03532464.
In between Oct 19, 2018, and April 17, 2020, we randomly assigned a total of 460 individuals
to possibly the doxycycline group (n=230) or the azithromycin team (n=230). 4 (1%)
of 460 individuals ended up excluded simply because they refused to take doxycycline or were
located to be ineligible following randomisation. Among the the 456 members, 357 (78%)
had a concurrent C trachomatis-good anorectal NAAT consequence at baseline 184 (52%) of 357 were being in the doxycycline
team and 173 (48%) have been in the azithromycin team (ie, the modified intention-to-take care of
populace). Microbiological anorectal remedy occurred in 147 (94%) of 156 individuals
in the doxycycline team (28 lacking values) as opposed to 120 (85%) of 142 in the azithromycin
group (31 missing values modified odds ratio with imputation of missing values 0·43
[95% CI 0·21–0·91] p=0·0274). Described adverse events possibly associated to treatment method
have been notified in 53 (12%) of 456 gals: 24 (11%) of 228 in the doxycycline group and
29 (13%) of 228 in the azithromycin group. Gastrointestinal issues had been the most
frequently developing, in 43 (9%) of 456 girls: 17 (8%) of 228 in the doxycycline team
and 26 (11%) of 228 in the azithromycin team.
The microbiological anorectal treatment price was drastically decreased amid girls who been given
a single dose of azithromycin than among those people who gained a 1-week program of doxycycline.
This obtaining indicates that doxycycline should be the initially-line treatment for C trachomatis an infection in females.
French Ministry of Wellbeing.
For the French translation of the abstract see Supplementary Products segment.