Monitoring therapy success of Chlamydia trachomatis infections using culture<br>A prospective observational cohort study.<br>
Completed
- Conditions
- 10040785ChlamydiaChlamydia trachomatis10004018
- Registration Number
- NL-OMON42309
- Lead Sponsor
- GGD Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Born to female sex
Age *18 years
Tested Ct NAAT-positive on urogenital swab
Eligible for azithromycin treatment (no allergies)
Willing to receive the routine treatment for Chlamydia trachomatis at the STI Outpatient Clinic
Accepting conditions of the study and signed informed consent
Exclusion Criteria
Tested NAAT-positive on urine sample only
Not being able to give informed consent, based on Dutch or English patient information
Ct infection in the past 3 months
Antibiotic treatment for which Chlamydia trachomatis is sensitive (rifampicin, tetracyclines, macrolides, sulfonamides, quinolones, clindamycin, penicillins, cephalosporins) between day -28 and day 0.
Unlikely to comply with the study requirements
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints: Clearance of Ct infection as determined by Ct culture and<br /><br>NAAT at days 7, 21 and 49 after treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoint: sensitivity of Ct culture when compared to Aptima Combo 2<br /><br>assay and COBAS® 4800 CT/NG TEST on the day of inclusion. To distinguish<br /><br>recurrent or persistent infections from new infections by determining if<br /><br>persistent Ct NAAT and/or culture positive results after treatment are caused<br /><br>by the same Ct strain.</p><br>