Vaginal Infection Clinical Trial
— CHLAZIDOXYOfficial 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.
Status | Not yet recruiting |
Enrollment | 460 |
Est. completion date | December 1, 2019 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female - Age > 18 years - Negative ß-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 - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | CeGGID - Bordeaux | Bordeaux | |
France | CHU de Bordeaux | Bordeaux | |
France | CeGIDD - Marseille | Marseille | Marignane |
France | CHU de Nantes | Nantes | |
France | Hôpital Hôtel Dieu | Paris | |
France | Hôpital de Roubaix | Roubaix | |
France | CHRU Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | USC EA 3671 Infections humaines à mycoplasmes et à chlamydiae |
France,
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. Review. — View Citation
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 — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nucleic Acid Amplification Assay result | C. trachomatis-positive NAAT result in anorectal specimens after treatment | 6 weeks | |
Secondary | 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 | Day 1 | |
Secondary | 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). | Day 1 | |
Secondary | 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). | 6 weeks | |
Secondary | 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). | 4 months |
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