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RecruitingNCT07596316

Using Urine to Study Antibodies & Functional Cell-Mediated Immunity in the Context of Chlamydia Trachomatis

Sponsor

Universiteit Antwerpen

Enrollment

73 participants

Start Date

Dec 10, 2025

Study Type

OBSERVATIONAL

Conditions

Chlamydia Trachomatis Genital Infection

Summary

The goal of this observational study is to learn if we can identify immune biomarkers in first-void urine and vaginal brush samples in Chlamydia trachomatis (CT) positive adult women. Participants will self-collect a first-void urine sample, self-collect a vaginal brush, and a blood sample will be collected by a healthcare worker. Participants will complete a questionnaire.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • Female
  • Chlamydia trachomatis NAAT positive vaginal sample or first-void urine sample.
  • Able to understand the information brochure and what the study is about.
  • Willing to give informed consent to use their samples for details described in the study protocol.

Exclusion Criteria7

  • Pregnancy (self-reported)
  • Being positive for Human Immunodeficiency Virus (HIV)
  • Women that underwent hysterectomy.
  • Menstruation at the time of sample collection.
  • Current use of antibiotics effective against Chlamydia trachomatis (doxycyline or azithromycine) or use of such antimicrobials in the past 14 days before participating in the study.
  • Participating in another clinical trial at the same time of participating in this study.
  • Having a history or current evidence of any condition or abnormality that might confound the results of the study or is not in the best interest of the individual to participate, in the opinion of the investigator.

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Interventions

DEVICESampling

Collection of first-void urine (i.e. the initial stream of urine) with the Colli-Pee device (Novosanis, Belgium) (one sample of approx. 20 mL). Collection of a vaginal brush sample with the Evalyn brush (Rovers Medical Devices, The Netherlands). Collection of blood samples (three blood tubes of approx. 9 mL).

Locations(1)

Violett Antwerp

Antwerp, Antwerp, Belgium

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NCT07596316