Chlamydia Trachomatis InfectionFemCureNCT02694497
Transmission of Genital and Extra-genital Chlamydia Trachomatis Infections in Women
An observational study of Chlamydia Trachomatis Infection, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Multicenter prospective cohort study in Chlamydia trachomatis positive women after regular treatment to understand the transmission of anorectal CT infections. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis Infection
- What is being tested?
- Chlamydia care as usual
- How many people
- 560 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2016to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Chlamydia trachomatis test positive (genital and or anorectal)
Who cannot join
- (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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Public Health Service South Limburg
Geleen, South Limburg, PO Box 2022, 6160 HA Geleen
About this study
Official title: 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.
Read the 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.
- Conditions
- Chlamydia Trachomatis Infection
- Being tested
- Chlamydia care as usual
- Keywords
- transmission, women, genital, anorectal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlamydia care as usualOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Chlamydia after treatment.
Detection of anorectal and genital CT by NAAT
Measured: 0-12 weeks after regular treatment
Secondary outcomes (3)
Culture of Chlamydia after treatment
Detection of viable CT
Measured: 0-12 weeks after regular treatment
Viability PCR of Chlamydia after treatment
Detection of viable CT
Measured: 0-12 weeks after regular treatment
CT concentration after treatment
CT-DNA concentration
Measured: 0-12 weeks after regular treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startApr 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chlamydia Trachomatis InfectionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Public Health Service South Limburg, Public Health Service Rotterdam, Public Health Service of Amsterdam, National Institute for Public Health and the Environment (RIVM), STIAIDSNetherlands
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694497
- Sponsor's protocol ID
- FemCure
- Acronym
- FemCure
- Status last verified
- Aug 2017
- First submitted
- 15 Feb 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Not yet
Publications
Dukers-Muijrers NH, Wolffs PF, Eppings L, Gotz 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 FemCure study: prospective multicentre study on the transmission of genital and extra-genital Chlamydia trachomatis infections in women receiving routine care. BMC Infect Dis. 2016 Aug 8;16:381. doi: 10.1186/s12879-016-1721-x.
PubMed 27502928Janssen KJH, Wolffs PFG, Hoebe CJPA, Heijman T, Gotz HM, Bruisten SM, Schim van der Loeff M, de Vries HJ, Dukers-Muijrers NHTM. Determinants associated with viable genital or rectal Chlamydia trachomatis bacterial load (FemCure). Sex Transm Infect. 2022 Feb;98(1):17-22. doi: 10.1136/sextrans-2020-054533. Epub 2021 Jan 13.
PubMed 33441449Dukers-Muijrers NHTM, Wolffs P, Lucchesi M, Gotz HM, De Vries H, Schim van der Loeff M, Bruisten SM, Hoebe CJPA. Oropharyngeal Chlamydia trachomatis in women; spontaneous clearance and cure after treatment (FemCure). Sex Transm Infect. 2021 Mar;97(2):147-151. doi: 10.1136/sextrans-2020-054558. Epub 2020 Jul 31.
PubMed 32737209Dukers-Muijrers NHTM, Janssen KJH, Hoebe CJPA, Gotz HM, Schim van der Loeff MF, de Vries HJC, Bruisten SM, Wolffs PFG. Spontaneous clearance of Chlamydia trachomatis accounting for bacterial viability in vaginally or rectally infected women (FemCure). Sex Transm Infect. 2020 Nov;96(7):541-548. doi: 10.1136/sextrans-2019-054267. Epub 2020 Feb 17.
PubMed 32066588Dukers-Muijrers NHTM, Wolffs PFG, de Vries HJC, Gotz HM, Janssen K, Hoebe CJPA. Viable Bacterial Load Is Key to Azithromycin Treatment Failure in Rectally Chlamydia trachomatis Infected Women (FemCure). J Infect Dis. 2019 Sep 13;220(8):1389-1390. doi: 10.1093/infdis/jiz267. No abstract available.
PubMed 31107956Dukers-Muijrers NHTM, Wolffs PFG, De Vries H, Gotz HM, Heijman T, Bruisten S, Eppings L, Hogewoning A, Steenbakkers M, Lucchesi M, Schim van der Loeff MF, Hoebe CJPA. Treatment Effectiveness of Azithromycin and Doxycycline in Uncomplicated Rectal and Vaginal Chlamydia trachomatis Infections in Women: A Multicenter Observational Study (FemCure). Clin Infect Dis. 2019 Nov 13;69(11):1946-1954. doi: 10.1093/cid/ciz050.
PubMed 30689759
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Transmission of Genital and Extra-genital Chlamydia Trachomatis Infections in Women Receiving Routine Care; Implications for Control Strategies
- ClinicalTrials.gov ID
- NCT02694497
- Acronym / sponsor ID
- FemCure / FemCure
- Conditions
- Chlamydia Trachomatis Infection
- Keywords
- transmission, women, genital, anorectal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Public Health Service South Limburg, Public Health Service Rotterdam, Public Health Service of Amsterdam, National Institute for Public Health and the Environment (RIVM), STIAIDSNetherlands
- Study start
- Apr 2016
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter prospective cohort study in Chlamydia trachomatis positive women after regular treatment to understand the transmission of anorectal CT infections.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Chlamydia trachomatis test positive (genital and or anorectal)
Key exclusion criteria (5 listed)
- (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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlamydia care as usual | Other | – |
Primary outcome
Detection of Chlamydia after treatment.
Time frame: 0-12 weeks after regular treatment
Detection of anorectal and genital CT by NAAT
3 secondary outcomes
Culture of Chlamydia after treatment
Time frame: 0-12 weeks after regular treatment
Viability PCR of Chlamydia after treatment
Time frame: 0-12 weeks after regular treatment
CT concentration after treatment
Time frame: 0-12 weeks after regular treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Results publication: PubMed 27502928Dukers-Muijrers NH, Wolffs PF, Eppings L, Gotz 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 FemCure study: prospective multicentre study on the transmission of genital and extra-genital Chlamydia trachomatis infections in women receiving routine care. BMC Infect Dis. 2016 Aug 8;16:381. doi: 10.1186/s12879-016-1721-x.
- Derived from this study: PubMed 33441449Janssen KJH, Wolffs PFG, Hoebe CJPA, Heijman T, Gotz HM, Bruisten SM, Schim van der Loeff M, de Vries HJ, Dukers-Muijrers NHTM. Determinants associated with viable genital or rectal Chlamydia trachomatis bacterial load (FemCure). Sex Transm Infect. 2022 Feb;98(1):17-22. doi: 10.1136/sextrans-2020-054533. Epub 2021 Jan 13.
- Derived from this study: PubMed 32737209Dukers-Muijrers NHTM, Wolffs P, Lucchesi M, Gotz HM, De Vries H, Schim van der Loeff M, Bruisten SM, Hoebe CJPA. Oropharyngeal Chlamydia trachomatis in women; spontaneous clearance and cure after treatment (FemCure). Sex Transm Infect. 2021 Mar;97(2):147-151. doi: 10.1136/sextrans-2020-054558. Epub 2020 Jul 31.
- Derived from this study: PubMed 32066588Dukers-Muijrers NHTM, Janssen KJH, Hoebe CJPA, Gotz HM, Schim van der Loeff MF, de Vries HJC, Bruisten SM, Wolffs PFG. Spontaneous clearance of Chlamydia trachomatis accounting for bacterial viability in vaginally or rectally infected women (FemCure). Sex Transm Infect. 2020 Nov;96(7):541-548. doi: 10.1136/sextrans-2019-054267. Epub 2020 Feb 17.
- Derived from this study: PubMed 31107956Dukers-Muijrers NHTM, Wolffs PFG, de Vries HJC, Gotz HM, Janssen K, Hoebe CJPA. Viable Bacterial Load Is Key to Azithromycin Treatment Failure in Rectally Chlamydia trachomatis Infected Women (FemCure). J Infect Dis. 2019 Sep 13;220(8):1389-1390. doi: 10.1093/infdis/jiz267. No abstract available.
- Derived from this study: PubMed 30689759Dukers-Muijrers NHTM, Wolffs PFG, De Vries H, Gotz HM, Heijman T, Bruisten S, Eppings L, Hogewoning A, Steenbakkers M, Lucchesi M, Schim van der Loeff MF, Hoebe CJPA. Treatment Effectiveness of Azithromycin and Doxycycline in Uncomplicated Rectal and Vaginal Chlamydia trachomatis Infections in Women: A Multicenter Observational Study (FemCure). Clin Infect Dis. 2019 Nov 13;69(11):1946-1954. doi: 10.1093/cid/ciz050.
- published study designLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Not yet
Related trials for Chlamydia Trachomatis Infection
RecruitingPhase 1
Phase 1 Study of Chlamydia Trachomatis mRNA Vaccine in Adults.
Chlamydia Trachomatis Immunization
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Not yet recruiting
Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Recruiting
A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities
Chlamydia, Gonorrhea
Recruiting
Improving Maternal and Child Health Through Point-of-care STI Testing
Treponema Pallidum Infection, Chlamydia Trachomatis Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chlamydia Trachomatis Infection, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Chlamydia after treatment. (time frame: 0-12 weeks after regular treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694497, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.