CHLAMOUR Study - Chlamydia at multiple anatomical sites

Completed

Conditions: Chlamydia
Sexually transmitted infection
10008555

Registration Number: NL-OMON48039

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

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 (<1 month) use of any antibiotics with some effect on chlamydia trachomatis (excluding e.g. frequently used metronidazole and nitrofurantoine), and being pregnant.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures