Design of the FemCure study: prospective multicentre study on the transmission of genital and extra-genital Chlamydia trachomatis infections in women receiving routine care

Nicole H.T.M. Dukers-Muijrers, Petra F G Wolffs, Lisanne Eppings, Hannelore M Götz, Sylvia M Bruisten, Maarten F Schim van der Loeff, Kevin Janssen, Mayk Lucchesi, Titia Heijman, Birgit H van Benthem, Jan E van Bergen, Servaas A Morre, Jos Herbergs, Gerjo Kok, Mieke Steenbakkers, Arjan A Hogewoning, Henry J de Vries, Christian J P A Hoebe

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Abstract

BACKGROUND: In women, anorectal infections with Chlamydia trachomatis (CT) are about as common as genital CT, yet the anorectal site remains largely untested in routine care. Anorectal CT frequently co-occurs with genital CT and may thus often be treated co-incidentally. Nevertheless, post-treatment detection of CT at both anatomic sites has been demonstrated. It is unknown whether anorectal CT may play a role in post-treatment transmission. This study, called FemCure, in women who receive routine treatment (either azithromycin or doxycycline) aims to understand the post-treatment transmission of anorectal CT infections, i.e., from their male sexual partner(s) and from and to the genital region of the same woman. The secondary objective is to evaluate other reasons for CT detection by nucleic acid amplification techniques (NAAT) such as treatment failure, in order to inform guidelines to optimize CT control.

METHODS: A multicentre prospective cohort study (FemCure) is set up in which genital and/or anorectal CT positive women (n = 400) will be recruited at three large Dutch STI clinics located in South Limburg, Amsterdam and Rotterdam. The women self-collect anorectal and vaginal swabs before treatment, and at the end of weeks 1, 2, 4, 6, 8, 10, and 12. Samples are tested for presence of CT-DNA (by NAAT), load (by quantitative polymerase chain reaction -PCR), viability (by culture and viability PCR) and CT type (by multilocus sequence typing). Sexual exposure is assessed by online self-administered questionnaires and by testing samples for Y chromosomal DNA. Using logistic regression models, the impact of two key factors (i.e., sexual exposure and alternate anatomic site of infection) on detection of anorectal and genital CT will be assessed.

DISCUSSION: The FemCure study will provide insight in the role of anorectal chlamydia infection in maintaining the CT burden in the context of treatment, and it will provide practical recommendations to reduce avoidable transmission. Implications will improve care strategies that take account of anorectal CT.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02694497 .

Original languageEnglish
Article number381
Number of pages9
JournalBMC Infectious Diseases
Volume16
Early online date2016
DOIs
Publication statusPublished - 8 Aug 2016

Keywords

  • Chlamydia trachomatis
  • Anorectal
  • Genital
  • Transmission
  • Heterosexual
  • ASYMPTOMATIC RECTAL CHLAMYDIA
  • NEISSERIA-GONORRHOEAE
  • ANORECTAL CHLAMYDIA
  • GENERAL-PRACTITIONERS
  • UROGENITAL CHLAMYDIA
  • PHARYNGEAL CHLAMYDIA
  • AZITHROMYCIN
  • MEN
  • SEX
  • DOXYCYCLINE

Cite this

Dukers-Muijrers, Nicole H.T.M. ; Wolffs, Petra F G ; Eppings, Lisanne ; Götz, Hannelore M ; Bruisten, Sylvia M ; Schim van der Loeff, Maarten F ; Janssen, Kevin ; Lucchesi, Mayk ; Heijman, Titia ; van Benthem, Birgit H ; van Bergen, Jan E ; Morre, Servaas A ; Herbergs, Jos ; Kok, Gerjo ; Steenbakkers, Mieke ; Hogewoning, Arjan A ; de Vries, Henry J ; Hoebe, Christian J P A. / Design of the FemCure study : prospective multicentre study on the transmission of genital and extra-genital Chlamydia trachomatis infections in women receiving routine care. In: BMC Infectious Diseases. 2016 ; Vol. 16.
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abstract = "BACKGROUND: In women, anorectal infections with Chlamydia trachomatis (CT) are about as common as genital CT, yet the anorectal site remains largely untested in routine care. Anorectal CT frequently co-occurs with genital CT and may thus often be treated co-incidentally. Nevertheless, post-treatment detection of CT at both anatomic sites has been demonstrated. It is unknown whether anorectal CT may play a role in post-treatment transmission. This study, called FemCure, in women who receive routine treatment (either azithromycin or doxycycline) aims to understand the post-treatment transmission of anorectal CT infections, i.e., from their male sexual partner(s) and from and to the genital region of the same woman. The secondary objective is to evaluate other reasons for CT detection by nucleic acid amplification techniques (NAAT) such as treatment failure, in order to inform guidelines to optimize CT control.METHODS: A multicentre prospective cohort study (FemCure) is set up in which genital and/or anorectal CT positive women (n = 400) will be recruited at three large Dutch STI clinics located in South Limburg, Amsterdam and Rotterdam. The women self-collect anorectal and vaginal swabs before treatment, and at the end of weeks 1, 2, 4, 6, 8, 10, and 12. Samples are tested for presence of CT-DNA (by NAAT), load (by quantitative polymerase chain reaction -PCR), viability (by culture and viability PCR) and CT type (by multilocus sequence typing). Sexual exposure is assessed by online self-administered questionnaires and by testing samples for Y chromosomal DNA. Using logistic regression models, the impact of two key factors (i.e., sexual exposure and alternate anatomic site of infection) on detection of anorectal and genital CT will be assessed.DISCUSSION: The FemCure study will provide insight in the role of anorectal chlamydia infection in maintaining the CT burden in the context of treatment, and it will provide practical recommendations to reduce avoidable transmission. Implications will improve care strategies that take account of anorectal CT.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02694497 .",
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author = "Dukers-Muijrers, {Nicole H.T.M.} and Wolffs, {Petra F G} and Lisanne Eppings and G{\"o}tz, {Hannelore M} and Bruisten, {Sylvia M} and {Schim van der Loeff}, {Maarten F} and Kevin Janssen and Mayk Lucchesi and Titia Heijman and {van Benthem}, {Birgit H} and {van Bergen}, {Jan E} and Morre, {Servaas A} and Jos Herbergs and Gerjo Kok and Mieke Steenbakkers and Hogewoning, {Arjan A} and {de Vries}, {Henry J} and Hoebe, {Christian J P A}",
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language = "English",
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Design of the FemCure study : prospective multicentre study on the transmission of genital and extra-genital Chlamydia trachomatis infections in women receiving routine care. / Dukers-Muijrers, Nicole H.T.M.; Wolffs, Petra F G; Eppings, Lisanne; Götz, Hannelore M; Bruisten, Sylvia M; Schim van der Loeff, Maarten F; Janssen, Kevin; Lucchesi, Mayk; Heijman, Titia; van Benthem, Birgit H; van Bergen, Jan E; Morre, Servaas A; Herbergs, Jos; Kok, Gerjo; Steenbakkers, Mieke; Hogewoning, Arjan A; de Vries, Henry J; Hoebe, Christian J P A.

In: BMC Infectious Diseases, Vol. 16, 381, 08.08.2016.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Design of the FemCure study

T2 - prospective multicentre study on the transmission of genital and extra-genital Chlamydia trachomatis infections in women receiving routine care

AU - Dukers-Muijrers, Nicole H.T.M.

AU - Wolffs, Petra F G

AU - Eppings, Lisanne

AU - Götz, Hannelore M

AU - Bruisten, Sylvia M

AU - Schim van der Loeff, Maarten F

AU - Janssen, Kevin

AU - Lucchesi, Mayk

AU - Heijman, Titia

AU - van Benthem, Birgit H

AU - van Bergen, Jan E

AU - Morre, Servaas A

AU - Herbergs, Jos

AU - Kok, Gerjo

AU - Steenbakkers, Mieke

AU - Hogewoning, Arjan A

AU - de Vries, Henry J

AU - Hoebe, Christian J P A

PY - 2016/8/8

Y1 - 2016/8/8

N2 - BACKGROUND: In women, anorectal infections with Chlamydia trachomatis (CT) are about as common as genital CT, yet the anorectal site remains largely untested in routine care. Anorectal CT frequently co-occurs with genital CT and may thus often be treated co-incidentally. Nevertheless, post-treatment detection of CT at both anatomic sites has been demonstrated. It is unknown whether anorectal CT may play a role in post-treatment transmission. This study, called FemCure, in women who receive routine treatment (either azithromycin or doxycycline) aims to understand the post-treatment transmission of anorectal CT infections, i.e., from their male sexual partner(s) and from and to the genital region of the same woman. The secondary objective is to evaluate other reasons for CT detection by nucleic acid amplification techniques (NAAT) such as treatment failure, in order to inform guidelines to optimize CT control.METHODS: A multicentre prospective cohort study (FemCure) is set up in which genital and/or anorectal CT positive women (n = 400) will be recruited at three large Dutch STI clinics located in South Limburg, Amsterdam and Rotterdam. The women self-collect anorectal and vaginal swabs before treatment, and at the end of weeks 1, 2, 4, 6, 8, 10, and 12. Samples are tested for presence of CT-DNA (by NAAT), load (by quantitative polymerase chain reaction -PCR), viability (by culture and viability PCR) and CT type (by multilocus sequence typing). Sexual exposure is assessed by online self-administered questionnaires and by testing samples for Y chromosomal DNA. Using logistic regression models, the impact of two key factors (i.e., sexual exposure and alternate anatomic site of infection) on detection of anorectal and genital CT will be assessed.DISCUSSION: The FemCure study will provide insight in the role of anorectal chlamydia infection in maintaining the CT burden in the context of treatment, and it will provide practical recommendations to reduce avoidable transmission. Implications will improve care strategies that take account of anorectal CT.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02694497 .

AB - BACKGROUND: In women, anorectal infections with Chlamydia trachomatis (CT) are about as common as genital CT, yet the anorectal site remains largely untested in routine care. Anorectal CT frequently co-occurs with genital CT and may thus often be treated co-incidentally. Nevertheless, post-treatment detection of CT at both anatomic sites has been demonstrated. It is unknown whether anorectal CT may play a role in post-treatment transmission. This study, called FemCure, in women who receive routine treatment (either azithromycin or doxycycline) aims to understand the post-treatment transmission of anorectal CT infections, i.e., from their male sexual partner(s) and from and to the genital region of the same woman. The secondary objective is to evaluate other reasons for CT detection by nucleic acid amplification techniques (NAAT) such as treatment failure, in order to inform guidelines to optimize CT control.METHODS: A multicentre prospective cohort study (FemCure) is set up in which genital and/or anorectal CT positive women (n = 400) will be recruited at three large Dutch STI clinics located in South Limburg, Amsterdam and Rotterdam. The women self-collect anorectal and vaginal swabs before treatment, and at the end of weeks 1, 2, 4, 6, 8, 10, and 12. Samples are tested for presence of CT-DNA (by NAAT), load (by quantitative polymerase chain reaction -PCR), viability (by culture and viability PCR) and CT type (by multilocus sequence typing). Sexual exposure is assessed by online self-administered questionnaires and by testing samples for Y chromosomal DNA. Using logistic regression models, the impact of two key factors (i.e., sexual exposure and alternate anatomic site of infection) on detection of anorectal and genital CT will be assessed.DISCUSSION: The FemCure study will provide insight in the role of anorectal chlamydia infection in maintaining the CT burden in the context of treatment, and it will provide practical recommendations to reduce avoidable transmission. Implications will improve care strategies that take account of anorectal CT.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02694497 .

KW - Chlamydia trachomatis

KW - Anorectal

KW - Genital

KW - Transmission

KW - Heterosexual

KW - ASYMPTOMATIC RECTAL CHLAMYDIA

KW - NEISSERIA-GONORRHOEAE

KW - ANORECTAL CHLAMYDIA

KW - GENERAL-PRACTITIONERS

KW - UROGENITAL CHLAMYDIA

KW - PHARYNGEAL CHLAMYDIA

KW - AZITHROMYCIN

KW - MEN

KW - SEX

KW - DOXYCYCLINE

U2 - 10.1186/s12879-016-1721-x

DO - 10.1186/s12879-016-1721-x

M3 - Article

C2 - 27502928

VL - 16

JO - BMC Infectious Diseases

JF - BMC Infectious Diseases

SN - 1471-2334

M1 - 381

ER -