Incubation Time and Test of Cure of Chlamydia Trachomatis

Completed

• Conditions: Chlamydia Trachomatis Infection

• Registration Number: NCT01448876
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Objective was to understand the dynamics of Chlamydia trachomatis (Ct) detection by nucleic acid amplification testing (NAAT) after treatment and consequences for test-of-cure practice.

Detailed Description

Prospective Cohort Study on Detection of Chlamydial ribosomal ribonucleic acid (rRNA) and deoxyribonucleic acid (DNA) in anorectal and cervicovaginal Chlamydia trachomatis (Ct) infections during 8 weeks after directly observed treatment with Azythromycin. The investigators systematically assessed presence of Ct plasmid DNA and rRNA through multiple time-sequential measurements following treatment with 1000mg Azythromycin. By convenience sampling at our outpatient sexually transmitted diseases (STD) clinic, 46 non-pregnant women and 6 men were included, contributing 45 cervicovaginal and 15 anorectal infections. Over a period of 8 weeks, patients provided a total of 1016 self-taken cervicovaginal and/or anorectal swabs (response: 94%). All patients were negative for Human immunodeficiency virus (HIV), gonorrhea and Lymphogranuloma venereum (LGV), tested in anorectal Ct. Usual care was applied by advising abstinence or safe sex for one week and by providing treatment for steady partners. Participants provided written informed consent.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-10
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Chlamydia trachomatis diagnosis,
• age >=18 years

Exclusion Criteria

• pregnancy,
• doxycycline treated-Ct,
• recent treatment with antibiotics,
• co-infections with other STD

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of detection of Chlamydial rRNA and DNA after treatment	0 to 52 days after treatment	At 1,2,3,4,5,6,7,9,12,16,19,23,26,30,37,44, and 52 days post treatment chlamydial rRNA and DNA is measured. Outcomes are the times to rRNA and/or DNA negative test results.

Trial Locations

Locations (1)

Public Health Service South Limburg; 🇳🇱 Geleen, South Limburg, Netherlands