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Monitoring therapy success of Chlamydia trachomatis infections using culture A prospective observational cohort study.

Monitoring therapy success of Chlamydia trachomatis infections using culture A prospective observational cohort study. - Chlamydia test-of-cure study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42309
Enrollment
200
Registered
2015-04-01
Start date
2015-08-18
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Chlamydia Chlamydia trachomatis

Interventions

Aptima Combo 2
Chlamydia
Test-of-cure

Sponsors

GGD Amsterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary endpoints: Clearance of Ct infection as determined by Ct culture and NAAT at days 7, 21 and 49 after treatment.

Secondary

MeasureTime frame
Secondary endpoint: sensitivity of Ct culture when compared to Aptima Combo 2 assay and COBAS® 4800 CT/NG TEST on the day of inclusion. To distinguish recurrent or persistent infections from new infections by determining if persistent Ct NAAT and/or culture positive results after treatment are caused by the same Ct strain.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)