Clinical trial NCT01448876: Incubation Time and Test of Cure of Chlamydia Trachomatis
Official title: Time to Cure Chlamydia Trachomatis: Prospective Cohort Study on Detection of Chlamydial RNA and DNA in Anorectal and Cervicovaginal Infections During 8 Weeks After Directly Observed Treatment With Azithromycin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chlamydia Trachomatis Infection
Keywords: Chlamydia trachomatis
anorectal
cervicovaginal
MSM
women
treatment
RNA
bacterial load
sexual behaviour
Azythromycin treated
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: By convenience sampling at our outpatient STD clinic, 46 non-pregnant women and 6 men were included, contributing 45 cervicovaginal and 15 anorectal infections.

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.

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

Primary outcomes:
measure: Duration of detection of Chlamydial rRNA and DNA after treatment
timeFrame: 0 to 52 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Geleen
country: Netherlands
facility: Public Health Service South Limburg
state: South Limburg
Study officials:
References:
citation: 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.