NCT03532464: CHLAZIDOXY

Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection

Status unknown Phase 4 Last updated 4 June 2018

What this trial tests

Phase 4 trial testing azithromycin in Chlamydia Trachomatis Infection in 460 participants. Status unknown.

Timeline

1 July 2018

Primary endpoint
1 December 2019

1 December 2019

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	460
Start date	1 July 2018
Primary completion	1 December 2019
Estimated completion	1 December 2019
Sites	7 locations across France

Drugs / interventions tested

• azithromycin (azithromycin) — full drug profile →
• doxycycline (doxycycline) — full drug profile →

Conditions studied

• Chlamydia Trachomatis Infection — all drugs for Chlamydia Trachomatis Infection →
• Vaginal Infection — all drugs for Vaginal Infection →
• Anal Infection — all drugs for Anal Infection →

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, female only, with Chlamydia Trachomatis Infection or Vaginal Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Peuchant O, Lhomme E, Martinet P, Grob A, et al · · 2022 · cited 14× · PMID 35550262 · DOI 10.1016/s1473-3099(22)00148-7
2. Randomized, open-label, multicenter study of azithromycin compared with doxycycline for treating anorectal Chlamydia trachomatis infection concomitant to a vaginal infection (CHLAZIDOXY study).
   Peuchant O, Lhomme E, Krêt M, Ghezzoul B, et al · · 2019 · cited 5× · PMID 30762806 · DOI 10.1097/md.0000000000014572