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

April 25, 2018 updated by: Maastricht University Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • South Limburg
      • Geleen, South Limburg, Netherlands, PO Box 2022, 6160 HA Geleen
        • Public Health Service South Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

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).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Chlamydia after treatment.
Time Frame: 0-12 weeks after regular treatment
Detection of anorectal and genital CT by NAAT
0-12 weeks after regular treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Culture of Chlamydia after treatment
Time Frame: 0-12 weeks after regular treatment
Detection of viable CT
0-12 weeks after regular treatment
Viability PCR of Chlamydia after treatment
Time Frame: 0-12 weeks after regular treatment
Detection of viable CT
0-12 weeks after regular treatment
CT concentration after treatment
Time Frame: 0-12 weeks after regular treatment
CT-DNA concentration
0-12 weeks after regular treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

National Institute for Public Health and the Environment (RIVM)
ZonMw: The Netherlands Organisation for Health Research and Development
Public Health Service of Amsterdam
Public Health Service South Limburg
Public Health Service Rotterdam
STIAIDSNetherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FemCure

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not yet

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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