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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01448876
Other study ID # Incure
Secondary ID
Status Completed
Phase N/A
First received October 4, 2011
Last updated February 15, 2016
Start date June 2009
Est. completion date July 2011

Study information

Verified date October 2011
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Public Health Service South Limburg Geleen South Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of detection of Chlamydial rRNA and DNA 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. 0 to 52 days after treatment No
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