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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01448876
First received: October 4, 2011
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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
Chlamydia Trachomatis Infection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Duration of detection of Chlamydial rRNA and DNA after treatment [ Time Frame: 0 to 52 days after treatment ] [ Designated as safety issue: No ]
    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


Enrollment: 52
Study Start Date: June 2009
Study Completion Date: July 2011
Groups/Cohorts
chlamydia care as usual

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448876

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

No publications provided by Maastricht University Medical Center

Additional 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
Study First Received: October 4, 2011
Last Updated: October 6, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Chlamydia trachomatis
anorectal
cervicovaginal
MSM
women
treatment
RNA
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
Infection
Genital Diseases, Male
Genital Diseases, Female
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014