Clinical Trials Logo
  1. Home
  2. Chlamydia Trachomatis Infection
  3. NCT01448876
  4. Details
NCT01448876 Clinical Trial

Incubation Time and Test of Cure of Chlamydia Trachomatis

Chlamydia Trachomatis Infection Clinical Trial

— Incure  

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

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
See also
  Status Clinical Trial Phase
Completed NCT04269434 - GonoScreen: Efficacy of Screening STIs in MSM N/A
Active, not recruiting NCT04139629 - Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and ART Outcomes in Women With TFI N/A
Completed NCT03107377 - Phase 2B/3 Double-blinded Placebo-controlled Phase 2/Phase 3
Completed NCT03098329 - Check it: A New Approach to Controlling Chlamydia Transmission in Young People N/A
Recruiting NCT03862495 - Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT N/A
Completed NCT05307991 - Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe
Terminated NCT02083276 - Mecillinam for Treatment of Genital Chlamydia Infection Phase 2
Active, not recruiting NCT06131749 - Genital Tract Infections, the Vaginal Microbiome and Gestational Age at Birth Among Pregnant Women in South Africa
Completed NCT03568695 - Detection of Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium by Real-time Multiplex Polymerase Chain Reaction (PCR) After Pooling Pharyngeal, Anorectal and Urinary Samples N/A
Not yet recruiting NCT06369220 - A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections N/A
Not yet recruiting NCT06395675 - Clinical Evaluation of the ID NOW™ CT/NG Test N/A
Completed NCT03970850 - NeuMoDx PrEDiCTiNG Study Evaluation Plan N/A
Completed NCT01631201 - Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women Phase 2
Completed NCT05216744 - Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection Phase 2
Recruiting NCT05581160 - Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST) N/A
Not yet recruiting NCT03532464 - Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection Phase 4
Not yet recruiting NCT06234943 - Pharmacy-based Testing and Treatment for Gonorrhea and Chlamydia N/A
Active, not recruiting NCT04050540 - Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP Phase 4
Completed NCT04955717 - Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences N/A
Active, not recruiting NCT05666778 - Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs Phase 2