CHLAMOUR Study - Chlamydia at multiple anatomical sites

CHLAMOUR Study - Chlamydia at multiple anatomical sites - CHLAMOUR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48039

Enrollment

Registered

2019-01-23

Start date

2019-03-11

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia Sexually transmitted infection

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: women, age 18 years or older, genital or anorectal CT diagnosis, and signed written informed consent.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: concurrently infected with Neisseria gonorrhoea (i.e., having an oral, vaginal or anal infection), previously diagnosed HIV or Syphilis, recent (

Design outcomes

Primary

Measure	Time frame
The main endpoint of this study is assessment of the viable CT concentration (viable load) at any of the anatomical sample locations. Other parameters used in this study as determinants to understand the endpoint are: -CT detection by commercial NAAT (standard routine care; CT positive Yes/No) -CT DNA concentration (total CT load) -CT detection by culture (reference method for viable CT detection; Viable CT Yes/No) For exploratory descriptive analysis we will investigate associated factors from self-reported questionnaire data (e.g. demographics, sexual behaviour, symptoms, etc.). These questionnaires are completed by patients as part of the standard routine care.	—

Measure

Time frame

The main endpoint of this study is assessment of the viable CT concentration (viable load) at any of the anatomical sample locations. Other parameters used in this study as determinants to understand the endpoint are: -CT detection by commercial NAAT (standard routine care; CT positive Yes/No) -CT DNA concentration (total CT load) -CT detection by culture (reference method for viable CT detection; Viable CT Yes/No) For exploratory descriptive analysis we will investigate associated factors from self-reported questionnaire data (e.g. demographics, sexual behaviour, symptoms, etc.). These questionnaires are completed by patients as part of the standard routine care.

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Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results