Chlamydia Trachomatis InfectionPhase 4CHLAZIDOXYNCT03532464
Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection
A Phase 4 study testing azithromycin and doxycycline in people with Chlamydia Trachomatis Infection and Vaginal Infection, run by University Hospital, Bordeaux at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chlamydia Trachomatis Infection, Vaginal Infection, Anal Infection
- What is being tested?
- azithromycin and doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 7 sitesFrance
- Study dates
- 10 Oct 2018to 17 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Consultation in one of the participating centers
- Agree to be contacted for follow-up
- Member or beneficiary of a social security system
- Free written informed consent signed by the participant and the investigator (no later than the inclusion day and before performing any examination required for the study)
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CeGGID - Bordeaux
Bordeaux, 33000
CHU de Bordeaux
Bordeaux, 33000
CeGIDD - Marseille
Marseille, Marignane, 13700
CHU de Nantes
Nantes, 44000
Hôpital Hôtel Dieu
Paris, 75004
Hôpital de Roubaix
Roubaix, 59170
CHRU Tours
Tours, 37000
About this study
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.
Read the detailed description
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.
- Being tested
- azithromycin, doxycycline
- Keywords
- Chlamydia Trachomatis, Infection, Vaginal, Anal
- Medical subject headings
- Vaginitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycinDrug
Also called Treatment
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.
doxycyclineDrug
Also called Treatment
The patients in the doxycycline group take one tablet of 100 mg twice a day for seven days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nucleic Acid Amplification Assay result
- trachomatis-positive NAAT result in anorectal specimens after treatment
Measured: 6 weeks
Secondary outcomes (4)
the number of women with an anorectal C. trachomatis infection concomitant to a vaginal infection
The prevalence of anorectal C. trachomatis infection concomitant to a vaginal infection is the number of women with an anorectal C. trachomatis infection divided by the total number of women included in the study
Measured: Day 1
C. trachomatis genotype
The number of subjects for whom the same C. trachomatis genotype profile will be identified in the vaginal-positive and anorectal-positive specimens obtained on the day of inclusion (self-infection), and in the anorectal-positive specimen obtained six weeks after treatment initiation (persistence) and in the vaginal-positive specimen obtained four months after treatment (autoinoculation).
Measured: Day 1
C. trachomatis genotype
The number of subjects for whom the same C. trachomatis genotype profile will be identified in the vaginal-positive and anorectal-positive specimens obtained on the day of inclusion (self-infection), and in the anorectal-positive specimen obtained six weeks after treatment initiation (persistence) and in the vaginal-positive specimen obtained four months after treatment (autoinoculation).
Measured: 6 weeks
C. trachomatis genotype
The number of subjects for whom the same C. trachomatis genotype profile will be identified in the vaginal-positive and anorectal-positive specimens obtained on the day of inclusion (self-infection), and in the anorectal-positive specimen obtained six weeks after treatment initiation (persistence) and in the vaginal-positive specimen obtained four months after treatment (autoinoculation).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start10 Oct 2018
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chlamydia Trachomatis InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label, multicenter
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertille de Barbeyrac, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532464
- Sponsor's protocol ID
- CHUBX 2016/26
- Other IDs
- 2013-004510-17
- Acronym
- CHLAZIDOXY
- Status last verified
- Apr 2026
- First submitted
- 9 May 2018
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35550262Rank 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.
PubMed 24421044Kong 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.
PubMed 25637520Kong 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.
PubMed 26220080Peuchant 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.
PubMed 30762806
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Multicenter Study of Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection
- ClinicalTrials.gov ID
- NCT03532464
- Acronym / sponsor ID
- CHLAZIDOXY / CHUBX 2016/26
- Keywords
- Chlamydia Trachomatis, Infection, Vaginal, Anal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label, multicenter
| Arm | Type | Receives |
|---|---|---|
| Patient treated by doxycycline | Experimental | Drug: doxycyclineThe 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. |
| Patients treated by azithromycin | Active comparator | Drug: azithromycinThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| azithromycinAlso: TreatmentThe route of administration is oral. It is administered at a dose of 1 g (4 tablets), as a single dose with or without food. | Drug | Patients treated by azithromycin |
| doxycyclineAlso: TreatmentThe patients in the doxycycline group take one tablet of 100 mg twice a day for seven days. | Drug | Patient treated by doxycycline |
Primary outcome
Nucleic Acid Amplification Assay result
Time frame: 6 weeks
C. trachomatis-positive NAAT result in anorectal specimens after treatment
4 secondary outcomes
the number of women with an anorectal C. trachomatis infection concomitant to a vaginal infection
Time frame: Day 1
C. trachomatis genotype
Time frame: Day 1
C. trachomatis genotype
Time frame: 6 weeks
C. trachomatis genotype
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Results publication: PubMed 35550262Peuchant 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.
- Results publication: PubMed 24421044Rank 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.
- Results publication: PubMed 25637520Kong 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.
- Results publication: PubMed 26220080Kong 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.
- Derived from this study: PubMed 30762806Peuchant 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertille de Barbeyrac, MD principal investigator
University Hospital, Bordeaux
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing azithromycin and doxycycline in people with Chlamydia Trachomatis Infection and Vaginal Infection, run by University Hospital, Bordeaux at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nucleic Acid Amplification Assay result (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03532464, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.