Chlamydia TrachomatisNCT00827970
Randomized Population-Based Study on Chlamydia Trachomatis Screening
A study testing Screening for urogenital Chlamydia trachomatis in people with Chlamydia Trachomatis and Infertility, run by University of Aarhus at 1 site in Denmark.
Trial summary
30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). Read more about this study
- Who is it for?
- Ages 21 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis, Infertility, Ectopic Pregnancy
- What is being tested?
- Screening for urogenital Chlamydia trachomatis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,000 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 1997to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- born in 1974, 1974 or 1976 AND living in Aarhus County October 1007
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Infectious Diseases, Aarhus University Hospital Skejby
Aarhus N, 8200
About this study
Official title: Populationbased Screening for Urogenital Chlamydia Trachomatis Infections by Use of Home-Obtained and Mailed Samples: A Randomized Study
30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis.
The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.
- Conditions
- Chlamydia Trachomatis, Infertility, Ectopic Pregnancy
- Being tested
- Screening for urogenital Chlamydia trachomatis
- Keywords
- mass screening
- Medical subject headings
- Infertility, Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for urogenital Chlamydia trachomatisBehavioural
Receeiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.
| Study group | Role | What they receive |
|---|---|---|
| 1 Screening | Experimental | Individuals receiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample. Receives: Behavioral: Screening for urogenital Chlamydia trachomatis |
| 2 Control | No intervention | Control group receiving usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term infertility complications
Measured: 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startOct 1997
- Primary completionFeb 1998
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chlamydia TrachomatisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus County, Denmark, Novo foundation, The Danish Medical Research Council
- Investigators
- Berit Andersen, MD, Ph.D., Principal investigator, Aarhus University Hospital Skejby, Department of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827970
- Sponsor's protocol ID
- Cesoirs01
- Status last verified
- Jan 2009
- First submitted
- 22 Jan 2009
- Last updated
- 23 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersen B, Olesen F, Moller JK, Ostergaard L. Population-based strategies for outreach screening of urogenital Chlamydia trachomatis infections: a randomized, controlled trial. J Infect Dis. 2002 Jan 15;185(2):252-8. doi: 10.1086/338268. Epub 2002 Jan 3.
PubMed 11807700Andersen B, van Valkengoed I, Sokolowski I, Moller JK, Ostergaard L, Olesen F. Impact of intensified testing for urogenital Chlamydia trachomatis infections: a randomised study with 9-year follow-up. Sex Transm Infect. 2011 Mar;87(2):156-61. doi: 10.1136/sti.2010.042192. Epub 2010 Nov 20.
PubMed 21097811
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Populationbased Screening for Urogenital Chlamydia Trachomatis Infections by Use of Home-Obtained and Mailed Samples: A Randomized Study
- ClinicalTrials.gov ID
- NCT00827970
- Acronym / sponsor ID
- Cesoirs01
- Conditions
- Chlamydia Trachomatis, Infertility, Ectopic Pregnancy
- Keywords
- mass screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus County, Denmark, Novo foundation, The Danish Medical Research Council
- Study start
- Oct 1997
- Primary completion
- Feb 1998 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis.
The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Screening | Experimental | Behavioral: Screening for urogenital Chlamydia trachomatisIndividuals receiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample. |
| 2 Control | No intervention | –Control group receiving usual care |
Who may qualify
- Ages
- 21 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- born in 1974, 1974 or 1976 AND living in Aarhus County October 1007
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for urogenital Chlamydia trachomatisReceeiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample. | Behavioural | 1 Screening |
Primary outcome
Long term infertility complications
Time frame: 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
- Results publication: PubMed 11807700Andersen B, Olesen F, Moller JK, Ostergaard L. Population-based strategies for outreach screening of urogenital Chlamydia trachomatis infections: a randomized, controlled trial. J Infect Dis. 2002 Jan 15;185(2):252-8. doi: 10.1086/338268. Epub 2002 Jan 3.
- Derived from this study: PubMed 21097811Andersen B, van Valkengoed I, Sokolowski I, Moller JK, Ostergaard L, Olesen F. Impact of intensified testing for urogenital Chlamydia trachomatis infections: a randomised study with 9-year follow-up. Sex Transm Infect. 2011 Mar;87(2):156-61. doi: 10.1136/sti.2010.042192. Epub 2010 Nov 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berit Andersen, MD, Ph.D. principal investigator
Aarhus University Hospital Skejby, Department of Infectious Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening for urogenital Chlamydia trachomatis in people with Chlamydia Trachomatis and Infertility, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term infertility complications (time frame: 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00827970, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2009.