Transmission of Genital and Extra-genital Chlamydia Trachomatis Infections in Women

Chlamydia Trachomatis Infection Clinical Trial

— FemCure  

Official title:

Understanding Transmission of Genital and Extra-genital Chlamydia Trachomatis Infections in Women Receiving Routine Care; Implications for Control Strategies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694497
• Other study ID #: FemCure
• Status: Completed
• First received: February 15, 2016
• Last updated: April 25, 2018
• Start date: April 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multicenter prospective cohort study in Chlamydia trachomatis positive women after regular treatment to understand the transmission of anorectal CT infections.

Description:

Rationale:

Current national and international strategies for the control of Chlamydia trachomatis (CT) critically fail to obtain a reduction in transmission. In women, anorectal infections are about as common as genital CT. Yet anorectal CT remain untested as sexually transmitted infection (STI) clinics, general practitioners, hospital and population testing initiatives largely focus on genital CT. Part of untested anorectal CT is incidentally treated with the treatments applied for genital CT, as in women anorectal CT is often concurrent with genital CT. Yet, it is unknown whether transmission of anorectal CT can still occur after currently recommended treatment. Anorectal and genital CT were observed quite often after regular treatment (up to 40% detection by nucleic acid amplification tests-NAAT). Proposed reasons for such detection include a new (re-)infection from a partner or self-infection from another anatomic, e.g. anorectal, site. Anorectal infections are a potential reservoir for ongoing transmission of genital and anorectal CT in the population, between partners and between anatomic sites of an individual. Yet, neither the transmission potential nor the transmission impact of anorectal infections has been reported. The scientific evidence for the optimal control strategy for anorectal CT and thereby CT in its totality, is lacking.

Objective:

To understand the transmission of anorectal CT infections in women, i.e. from their male sexual partner(s) and from and to the genital region of the same woman, in women who receive routine care, in order to inform guidelines to optimize CT control.

Study population:

Participants are recruited from 3 large Dutch STI clinics, in South Limburg, Amsterdam and Rotterdam. Eligible participants are likely to reflect the STI clinic population, in terms of age, ethnicity and level of education. Participants include genital and/or anorectal CT positive women (n=400).

Study design:

A multicentre prospective cohort study is set up with biological and behavioural measurements after routine treatment of CT. During 3 months, the participants will be studied using a self-administered anorectal and vaginal swab that is self-collected pre-treatment (T0), and at the end of weeks 1, 2, 4, 6, 8, 10, and 12. Samples are tested using NAAT for presence of CT-DNA (detection), concentration (load), viability (weeks 4,8, and 12), and CT type (multilocus sequence typing-MLST) to confirm re-infection. To validate sexual exposure, chromosomal Y DNA (as a marker for semen exposure) in genital and anorectal samples is applied. At each sampling time, online self-administered questionnaires on behaviour (e.g. anorectal exposure) and symptoms will be completed.

Outcomes:

The outcome is detection of anorectal and genital CT at any of the time -points.

Primary outcome is incident detection by NAAT, and secondary outcomes include detection of viable CT and CT-DNA concentration.

Statistical analyses:

In statistical analyses, using logistic regression models, the impact of two key factors will be assessed (i.e. sexual exposure and alternate anatomic site of infection) on detection of anorectal and genital CT. In sub-analyses, the role of treatment-type is evaluated.

Expected results:

This project will provide scientific insight in the role of anorectal CT in maintaining the CT burden, and it will provide practical recommendations (STI guidelines) to reduce avoidable transmission. Implications will be to improve care strategies for (re-)testing and partner management that currently largely neglect anorectal CT, benefitting the individual (better fitting care) and public health (reducing burden) and eventually cost-effectiveness of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chlamydia trachomatis test positive (genital and or anorectal)

Exclusion Criteria:

• (reported) co-infection with gonorrhoea

• (reported) co-infection with HIV

• (reported) co-infection with syphilis

• (reported) pregnant

• (reported) anti-Chlamydial antibiotic use (period screening-treatment)

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis Infection
• Communicable Diseases
• Infection

Intervention

Other:
• Chlamydia care as usual

Locations

Country	Name	City	State
Netherlands	Public Health Service South Limburg	Geleen	South Limburg

Sponsors (7)

Lead Sponsor	Collaborator
Maastricht University Medical Center	National Institute for Public Health and the Environment (RIVM), Public Health Service of Amsterdam, Public Health Service Rotterdam, Public Health Service South Limburg, STIAIDSNetherlands, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Dukers-Muijrers NH, Wolffs PF, Eppings L, Götz HM, Bruisten SM, Schim van der Loeff MF, Janssen K, Lucchesi M, Heijman T, van Benthem BH, van Bergen JE, Morre SA, Herbergs J, Kok G, Steenbakkers M, Hogewoning AA, de Vries HJ, Hoebe CJ. Design of the FemCu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Chlamydia after treatment.	Detection of anorectal and genital CT by NAAT	0-12 weeks after regular treatment
Secondary	Culture of Chlamydia after treatment	Detection of viable CT	0-12 weeks after regular treatment
Secondary	Viability PCR of Chlamydia after treatment	Detection of viable CT	0-12 weeks after regular treatment
Secondary	CT concentration after treatment	CT-DNA concentration	0-12 weeks after regular treatment

External Links

•   published study design