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

NCT03532464 | Completed Phase 4

• 2 other identifiers: CHUBX 2016/262013-004510-17
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Anal Infection; Chlamydia Trachomatis Infection; Vaginal Infection

Keywords

Chlamydia Trachomatis; Infection; Vaginal; Anal

Outcome Measures

Primary Outcomes (1)

• Nucleic Acid Amplification Assay result

  C. trachomatis-positive NAAT result in anorectal specimens after treatment

  6 weeks

Secondary Outcomes (4)

• the number of women with an anorectal C. trachomatis infection concomitant to a vaginal infection

  Day 1

• C. trachomatis genotype

  Day 1

• C. trachomatis genotype

  6 weeks

• C. trachomatis genotype

  4 months

Study Arms (2)

Patient treated by doxycycline

EXPERIMENTAL

The patients in the doxycycline group take one tablet of 100 mg twice a day for seven days. Antibiotics will be dispensed in their usual packaging with a clinical trial label.

Drug: doxycycline

Patients treated by azithromycin

ACTIVE COMPARATOR

The patients in the azithromycin group take 4 tablets of 250 mg in the morning as a single dose. Antibiotics will be dispensed in their usual packaging with a clinical trial label.

Drug: azithromycin

Interventions

azithromycin DRUG

The route of administration is oral. It is administered at a dose of 1 g (4 tablets), as a single dose with or without food.

Also known as: Treatment

Patients treated by azithromycin

doxycycline DRUG

The patients in the doxycycline group take one tablet of 100 mg twice a day for seven days.

Also known as: Treatment

Patient treated by doxycycline

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: A screening of vaginal C. trachomatis infection is performed among women consulting at a CeGIDD or at a termination pregnancy center before an abortion. C. trachomatis NAAT result will be available one week later, when the patient returns for consultation. In each participating center, a study site coordinator will screen all women with a C. trachomatis-positive vaginal swab and will verify eligibility criteria for inclusion in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age \> 18 years
• Negative β-hCG urinary assay and efficacious contraception for participant consulting in specialist centre
• Participant requesting an abortion at a pregnancy termination centre and efficacious contraception after abortion
• C. trachomatis-positive test for vaginal specimen using a Nucleic Acid Amplification Test (NAAT)
• Sexually active
• Consultation in one of the participating centers
• Agree to be contacted for follow-up
• Member or beneficiary of a social security system

You may not qualify if:

• Women who have symptoms suggesting pelvic inflammatory disease (PID)
• Receipt of an antibiotic with antichlamydial activity within 21 days before screening or between screening and enrollment
• Contraindications to tetracyclines, macrolides or ketolids (including allergy and treatment with colchicine, cisapride, ergot alkaloids and retinoids)
• Inability to swallow pills
• Refusal to participate in the study
• Objectives of the study not understood.
• Breast-feeding
• Patients with serious cardiac diseases: documented prolongation of the QT tract of the ECG, cardiac arrhythmias, advanced heart failure (classification New York Heart Association or NYHA \>III)
• Patients treated with anticoagulants or drug with a definite potential of "Torsades de Pointe" or prolongation of the QT tract of the electrocardiogram
• Patients with severe liver diseases

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (7)

CeGIDD - Marseille

Marseille, Marignane, 13700, France

Location

CeGGID - Bordeaux

Bordeaux, 33000, France

Location

CHU de Bordeaux

Bordeaux, 33000, France

Location

CHU de Nantes

Nantes, 44000, France

Location

Hôpital Hôtel Dieu

Paris, 75004, France

Location

Hôpital de Roubaix

Roubaix, 59170, France

Location

CHRU Tours

Tours, 37000, France

Location

Related Publications (5)

• Peuchant O, Lhomme E, Martinet P, Grob A, Baita D, Bernier C, Gibaud SA, Le Hen I, Le Naour E, Trignol-Viguier N, Lanotte P, Lefebvre P, Vachee A, Girard T, Loubinoux J, Bebear C, Ghezzoul B, Roussillon C, Kret M, de Barbeyrac B; CHLAZIDOXY Study Group. 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. Lancet Infect Dis. 2022 Aug;22(8):1221-1230. doi: 10.1016/S1473-3099(22)00148-7. Epub 2022 May 9.

  PMID: 35550262 RESULT

• Rank RG, Yeruva L. Hidden in plain sight: chlamydial gastrointestinal infection and its relevance to persistence in human genital infection. Infect Immun. 2014 Apr;82(4):1362-71. doi: 10.1128/IAI.01244-13. Epub 2014 Jan 13.

  PMID: 24421044 RESULT

• Kong FY, Tabrizi SN, Fairley CK, Vodstrcil LA, Huston WM, Chen M, Bradshaw C, Hocking JS. The efficacy of azithromycin and doxycycline for the treatment of rectal chlamydia infection: a systematic review and meta-analysis. J Antimicrob Chemother. 2015 May;70(5):1290-7. doi: 10.1093/jac/dku574. Epub 2015 Jan 29.

  PMID: 25637520 RESULT

• Kong FY, Hocking JS. Treatment challenges for urogenital and anorectal Chlamydia trachomatis. BMC Infect Dis. 2015 Jul 29;15:293. doi: 10.1186/s12879-015-1030-9.

  PMID: 26220080 RESULT

• Peuchant O, Lhomme E, Kret M, Ghezzoul B, Roussillon C, Bebear C, Perry F, de Barbeyrac B; and the Chlazidoxy study group. Randomized, open-label, multicenter study of azithromycin compared with doxycycline for treating anorectal Chlamydia trachomatis infection concomitant to a vaginal infection (CHLAZIDOXY study). Medicine (Baltimore). 2019 Feb;98(7):e14572. doi: 10.1097/MD.0000000000014572.

  PMID: 30762806 DERIVED

MeSH Terms

Conditions

Vaginitis; Infections

Interventions

Azithromycin; Therapeutics; Doxycycline

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Bertille de Barbeyrac, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, open-label, multicenter

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 22, 2018
• Study Start: October 10, 2018
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: June 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)