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

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ClinicalTrials.gov Identifier: NCT02694497
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : April 26, 2018
Sponsor:
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
Information provided by (Responsible Party):
Maastricht University Medical Center

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

Condition or disease Intervention/treatment
Chlamydia Trachomatis Infection Other: Chlamydia care as usual

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Study Type : Observational
Actual Enrollment : 560 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Understanding Transmission of Genital and Extra-genital Chlamydia Trachomatis Infections in Women Receiving Routine Care; Implications for Control Strategies
Study Start Date : April 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Detection of Chlamydia after treatment. [ Time Frame: 0-12 weeks after regular treatment ]
    Detection of anorectal and genital CT by NAAT


Secondary Outcome Measures :
  1. Culture of Chlamydia after treatment [ Time Frame: 0-12 weeks after regular treatment ]
    Detection of viable CT

  2. Viability PCR of Chlamydia after treatment [ Time Frame: 0-12 weeks after regular treatment ]
    Detection of viable CT

  3. CT concentration after treatment [ Time Frame: 0-12 weeks after regular treatment ]
    CT-DNA concentration


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694497


Locations
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Netherlands
Public Health Service South Limburg
Geleen, South Limburg, Netherlands, PO Box 2022, 6160 HA Geleen
Sponsors and Collaborators
Maastricht University Medical Center
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
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02694497    
Other Study ID Numbers: FemCure
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not yet
Keywords provided by Maastricht University Medical Center:
transmission
women
genital
anorectal
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female