Incubation Time and Test of Cure of Chlamydia Trachomatis

NCT ID: NCT01448876

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-07-31

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.

Conditions

Chlamydia Trachomatis Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

chlamydia care as usual

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Chlamydia trachomatis diagnosis,
• age >=18 years

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Public Health Service South Limburg

Geleen, South Limburg, Netherlands

Countries

Netherlands

References

Dukers-Muijrers NH, Speksnijder AG, Morre SA, Wolffs PF, van der Sande MA, Brink AA, van den Broek IV, Werner MI, Hoebe CJ. Detection of anorectal and cervicovaginal Chlamydia trachomatis infections following azithromycin treatment: prospective cohort study with multiple time-sequential measures of rRNA, DNA, quantitative load and symptoms. PLoS One. 2013 Nov 20;8(11):e81236. doi: 10.1371/journal.pone.0081236. eCollection 2013.

Reference Type: DERIVED

PMID: 24278400 (View on PubMed)

Other Identifiers

Incure

Identifier Type: -

Identifier Source: org_study_id