NCT01448876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
Last Updated

February 17, 2016

Status Verified

October 1, 2011

Enrollment Period

2.1 years

First QC Date

October 4, 2011

Last Update Submit

February 15, 2016

Conditions

Chlamydia Trachomatis Infection

Keywords

Chlamydia trachomatisanorectalcervicovaginalMSMwomentreatmentRNAbacterial loadsexual behaviourAzythromycin treated

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

chlamydia care as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Chlamydia trachomatis diagnosis,
  • age \>=18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Service South Limburg

Geleen, South Limburg, PO Box 2022, 6160 HA Geleen, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 24278400DERIVED

Biospecimen

self-taken cervicovaginal and snorectal swabs

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 7, 2011

Study Start

June 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 17, 2016

Record last verified: 2011-10

Locations

NL(1)