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Incubation Time and Test of Cure of Chlamydia Trachomatis (Incure)

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ClinicalTrials.gov Identifier: NCT01448876
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Chlamydia Trachomatis Infection

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 Design

Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : June 2009
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

chlamydia care as usual

Outcome Measures

Primary Outcome Measures :
  1. Duration of detection of Chlamydial rRNA and DNA after treatment [ Time Frame: 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.

Biospecimen Description:
self-taken cervicovaginal and snorectal swabs

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Inclusion Criteria:

  • Chlamydia trachomatis diagnosis,
  • age >=18 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448876

Public Health Service South Limburg
Geleen, South Limburg, Netherlands, PO Box 2022, 6160 HA Geleen
Sponsors and Collaborators
Maastricht University Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01448876     History of Changes
Other Study ID Numbers: Incure
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: October 2011

Keywords provided by Maastricht University Medical Center:
Chlamydia trachomatis
bacterial load
sexual behaviour
Azythromycin treated

Additional relevant MeSH terms:
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female