A study of Chlamydia trachomatis infection and reinfection in young adults

Not Applicable

Recruiting

• Conditions: Bacterial Infection; Infection - Other infectious diseases

• Registration Number: ACTRN12624000274572
• Lead Sponsor: Sanofi Pasteur Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-18
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Aged 18 to 29 years on the day of inclusion
2 .New sex partner within the past 6 months, or more than one current sex partner, or partner with known sexually transmitted infection (STI), or inconsistent condom use.
3. For persons living with human immunodeficiency virus (HIV): participant with a stable HIV infection determined by a CD4 count greater than 200/mm3, and currently on antiretrovirals for at least 6 months
4. A female participant is eligible to participate if she is not pregnant. A female participant of childbearing potential must have a negative highly sensitive urine pregnancy test at the enrollment visit (V01).
5. Informed consent form has been signed and dated.
6. Able to attend all scheduled visits and to comply with all study procedures

Exclusion Criteria

1. Known or suspected congenital immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
2. Unstable acute or chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
3. For female participants, is menstruating at the time of enrollment visit. Enrollment visit can be postponed until the menstruation period ends.
4. Genital or rectal douching from 48 hours before enrollment visit. Enrollment visit can be postponed until more than 48 hours have passed after the last genital or rectal douching.
5. Documented hysterectomy
6. Receipt of immune globulins, blood or blood-derived products in the past 3 months
7. Receipt of oral or injectable prohibited antibiotic therapy within 21 days prior to enrollment visit (prohibited antibiotics include azithromycin, erythromycin, doxycycline, levofloxacin, ofloxacin, ceftriaxone, amoxicillin, ciprofloxacin, tetracycline, and cefixime).
Enrollment visit can be postponed until more than 21 days have passed after the last receipt of an antibiotic.
8. Participation at the time of study enrollment (or in the 3 months preceding the enrollment) or planned participation during the present study period in another clinical study investigating a vaccine, or a drug.
9. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
10. Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study

Study & Design

• Study Type: Observational
• Study Design: Not specified