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

NCT02694497 | Completed DMC

• 1 other identifier: FemCure
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chlamydia Trachomatis Infection

Keywords

transmission; women; genital; anorectal

Outcome Measures

Primary Outcomes (1)

• Detection of Chlamydia after treatment.

  Detection of anorectal and genital CT by NAAT

  0-12 weeks after regular treatment

Secondary Outcomes (3)

• Culture of Chlamydia after treatment

  0-12 weeks after regular treatment

• Viability PCR of Chlamydia after treatment

  0-12 weeks after regular treatment

• CT concentration after treatment

  0-12 weeks after regular treatment

Interventions

Chlamydia care as usual OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Chlamydia trachomatis test positive (genital and or anorectal)

You may not qualify if:

• (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)

Sponsors & Collaborators

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

Study Sites (1)

Public Health Service South Limburg

Geleen, South Limburg, PO Box 2022, 6160 HA Geleen, Netherlands

Location

Related Publications (6)

• 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.

  PMID: 27502928 RESULT

• Janssen 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.

  PMID: 33441449 DERIVED

• Dukers-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.

  PMID: 32737209 DERIVED

• Dukers-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.

  PMID: 32066588 DERIVED

• Dukers-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.

  PMID: 31107956 DERIVED

• Dukers-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.

  PMID: 30689759 DERIVED

Related Links

• published study design

Biospecimen

Retention: SAMPLES WITH DNA

Participants will collect a self-administered anorectal and vaginal swab at 8 time-points: pre-treatment during the visit at the STI clinic at which the treatment is given (T0), and at the end of weeks 1, 2, 4, 6, 8, 10, and 12. At T0, T4, T8 and T12 (visits at the clinic), the participants take an additional self-administered anorectal and vaginal swab that is otherwise exactly the same as the home-taken samples, but stored in a different buffer and processed immediately, i.e. cooled at -80°C within 24 hours, to allow CT viability testing. At the clinic visit, we will also consider to obtain a nurse-taken pharyngeal swab for later CT testing. For self-collection of the anorectal and genital samples, participants receive clear instructions.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 29, 2016
• Study Start: April 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 26, 2018

Record last verified: 2017-08

Locations

NL (1)