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Chlamydia TrachomatisNCT07002047

Real World and Epidemiology Study of Medically Attended Chlamydia Trachomatis Among Adults in Germany

An observational study of Chlamydia Trachomatis, run by Sanofi at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study assesses the epidemiologic situation of chlamydia trachomatis, its complications and long term sequalae and related healthcare resource utilization and costs among adults in Germany. Read more about this study

Who is it for?
Ages 14 to 44 years
Conditions the study is for
Chlamydia Trachomatis
How many people
81,239 participants
Where
1 siteGermany
Study dates
13 Mar 2025to 31 Dec 2025
Phase
Observational
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 14 to 44 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Adolescents and adults aged 14 to 44 years in the years 2008-2022 with documented (confirmed) diagnosis of CT.

Who may be able to join

  • Either male or female is documented as gender in base data
  • At cohort entry, a patient must be aged between 14 and 44 years

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Study site

    Germany

Other trials in Germany

About this study

This study assesses the epidemiologic situation of chlamydia trachomatis, its complications and long term sequalae and related healthcare resource utilization and costs among adults in Germany.

The study is a retrospective cohort study based on German Statutory Health Insurance (SHI) claims data for adolescents and adults aged 14 to 44 years in the years 2008-2022 with documented (confirmed) diagnosis of CT.

Read more

Study Objectives are to:

  1. Estimate frequency of potential short-term complications and long-term sequelae in patients with medically attended chlamydia infection
  2. Analyze time from first documented prevalent CT infection to first potential complication/sequelae diagnosis
  3. Estimate frequency of re-infection (chlamydia recurrence) and co-infections with other sexually transmitted infections (STIs) in patients with medically-attended chlamydia infection
  4. Estimate absolute healthcare resource utilization (by level of care and specialty) and costs in patients with chlamydia infection, including for potential short-term complications and long-term sequelae
  5. Estimate administrative prevalence of medically-attended chlamydia infection in the overall study population
  6. Estimate administrative prevalence of diagnoses potentially associated with a chlamydia infection (i.e., short-term complications/long-term sequelae) in the overall study population
  7. Estimate frequency of chlamydia testing in the overall study population

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07002047
Study groupRoleWhat they receive
Male and Female Adolescents and Adults with CTMale and Female patients aged between 14 and 44 years of age with documented (confirmed) CT diagnosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of female participants with documented (confirmed) outpatient or any inpatient of pelvic inflammatory disease (PID)

    The absolute frequency of documented cases will be reported. The relative frequency will be computed as the proportion of patients under exposure (first documented prevalent CT infection) which become cases

    Measured: From Year 2008 to Year 2022

  2. Number of female participants with documented confirmed outpatient or any inpatient diagnosis of ectopic pregnancy

    The absolute frequency of documented cases will be reported. The relative frequency will be computed as the proportion of patients under exposure (first documented prevalent CT infection) which become cases

    Measured: From Year 2008 to Year 2022

  3. Number of female participants with documented confirmed outpatient or any inpatient diagnosis tubal factor infertility

    The absolute frequency of documented cases will be reported. The relative frequency will be computed as the proportion of patients under exposure (first documented prevalent CT infection) which become cases

    Measured: From Year 2008 to Year 2022

  4. Number of male participants with documented confirmed outpatient or any inpatient diagnosis of orchitis or epididymitis

    The absolute frequency of documented cases will be reported. The relative frequency will be computed as the proportion of patients under exposure (first documented prevalent CT infection) which become cases

    Measured: From Year 2008 to Year 2022

  5. Number of male participants with documented confirmed outpatient or any inpatient diagnosis of proctitis

    The absolute frequency of documented cases will be reported. The relative frequency will be computed as the proportion of patients under exposure (first documented prevalent CT infection) which become cases

    Measured: From Year 2008 to Year 2022

  6. Number of male participants with documented confirmed outpatient or any inpatient diagnosis of prostatitis

    The absolute frequency of documented cases will be reported. The relative frequency will be computed as the proportion of patients under exposure (first documented prevalent CT infection) which become cases

    Measured: From Year 2008 to Year 2022

  7. Number of male and female participants with documented confirmed outpatient or any inpatient diagnosis of female/male infertility

    The absolute frequency of documented cases will be reported. The relative frequency will be computed as the proportion of patients under exposure (first documented prevalent CT infection) which become cases

    Measured: From Year 2008 to Year 2022

  8. Number of male and female participants with documented confirmed outpatient or any inpatient diagnosis of Urethritis and urethral syndrome

    The absolute frequency of documented cases will be reported. The relative frequency will be computed as the proportion of patients under exposure (first documented prevalent CT infection) which become cases

    Measured: From Year 2008 to Year 2022

  9. Time in days from first documented prevalent CT infection to first documented complication/sequelae diagnosis

    This time-to-event analysis will use the Kaplan-Meier method to estimate the median time-to-event in the presence of censoring

    Measured: From Year 2008 to Year 2022

  10. Number of male and female participants with confirmed outpatient or any inpatient CT diagnosis at least 30 days after last CT diagnosis of any kind (reinfection)

    The absolute number of documented cases will be reported. The relative frequency will be computed as the proportion of patients under exposure (first documented prevalent CT infection) which become cases.

    Measured: From Year 2008 to Year 2022

  11. Number of CT reinfections/episodes

    The absolute number of documented cases will be reported. The relative frequency will be computed as the proportion of patients under exposure (first documented prevalent CT infection) which become cases.

    Measured: From Year 2008 to Year 2022

  12. Number of male and female participants with documented confirmed outpatient or any inpatient diagnosis of other STI

    The absolute number of documented cases will be reported. The relative frequency will be computed as the proportion of patients under exposure (first documented prevalent CT infection) which become cases.

    Measured: From Year 2008 to Year 2022

  13. Cost incurred from the number of physician contacts (of any specialty)

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  14. Costs incurred from the number of hospital admissions

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  15. Costs incurred for the number of prescriptions filled for any drug

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  16. Costs incurred for the number of filled prescriptions for any medical aid

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  17. Costs incurred for the number of physician contacts (of any specialty) related to CT or STI-diagnoses.

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  18. Costs incurred for the number of hospital admissions related to CT or STI-diagnoses.

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  19. Costs incurred for the number of filled prescriptions for CT-related antibiotics, dispensed within 30 days after CT diagnosis

    Costs are summed up per patient for the specified follow-up time and numbers for each ATC code will be reported separately and in aggregated form

    Measured: From Year 2008 to Year 2022

  20. Costs incurred for the number of filled prescriptions for medical aids related to CT or STI diagnoses

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  21. Total CT-/STI-unspecific health care costs (inpatient, outpatient, drugs, medical aids)

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  22. CT-/STI-unspecific outpatient costs

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  23. CT-/STI-unspecific inpatient costs

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  24. CT-/STI-unspecific drug cost

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  25. CT-/STI-unspecific medical aid costs

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  26. Outpatient costs that are related to cases with a confirmed CT diagnosis

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  27. Inpatient costs that are related to cases with any CT diagnosis

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  28. Outpatient costs that are related to cases with any confirmed STI diagnosis

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  29. Inpatient costs that are related to cases with any confirmed STI diagnosis

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

  30. Costs of potentially CT-relevant antibiotics dispensed up to 30 days after confirmend outpatient or any inpatient CT diagnosis

    Costs are summed up per patient for the specified follow-up time

    Measured: From Year 2008 to Year 2022

Secondary outcomes (11)
  1. Confirmed outpatient or any inpatient CT diagnosis

    The absolute number of prevalent cases per calendar year will be reported for each outcome. Due to the possibility of multiple infections per person the number of affected individuals will also be reported. The relative frequency will be computed as the proportion of patients which become cases

    Measured: From Year 2008 to Year 2022

  2. Confirmed outpatient or any inpatient of PID (CT associated, or other origin) in females

    The absolute number of prevalent cases per calendar year will be reported for each outcome. Due to the possibility of multiple infections per person the number of affected individuals will also be reported. The relative frequency will be computed as the proportion of patients which become cases

    Measured: From Year 2008 to Year 2022

  3. First documented confirmed outpatient or any inpatient diagnosis of ectopic pregnancy in females

    The absolute number of prevalent cases per calendar year will be reported for each outcome. Due to the possibility of multiple infections per person the number of affected individuals will also be reported. The relative frequency will be computed as the proportion of patients which become cases

    Measured: From Year 2008 to Year 2022

  4. First documented confirmed outpatient or any inpatient diagnosis tubal factor infertility in females

    The absolute number of prevalent cases per calendar year will be reported for each outcome. Due to the possibility of multiple infections per person the number of affected individuals will also be reported. The relative frequency will be computed as the proportion of patients which become cases

    Measured: From Year 2008 to Year 2022

  5. First documented confirmed outpatient or any inpatient diagnosis of orchitis or epididymitis in males

    The absolute number of prevalent cases per calendar year will be reported for each outcome. Due to the possibility of multiple infections per person the number of affected individuals will also be reported. The relative frequency will be computed as the proportion of patients which become cases

    Measured: From Year 2008 to Year 2022

  6. First documented confirmed outpatient or any inpatient diagnosis of proctitis in males

    The absolute number of prevalent cases per calendar year will be reported for each outcome. Due to the possibility of multiple infections per person the number of affected individuals will also be reported. The relative frequency will be computed as the proportion of patients which become cases

    Measured: From Year 2008 to Year 2022

  7. First documented confirmed outpatient or any inpatient diagnosis of prostatitis in males

    The absolute number of prevalent cases per calendar year will be reported for each outcome. Due to the possibility of multiple infections per person the number of affected individuals will also be reported. The relative frequency will be computed as the proportion of patients which become cases

    Measured: From Year 2008 to Year 2022

  8. First documented confirmed outpatient or any inpatient diagnosis of infertility in males

    The absolute number of prevalent cases per calendar year will be reported for each outcome. Due to the possibility of multiple infections per person the number of affected individuals will also be reported. The relative frequency will be computed as the proportion of patients which become cases

    Measured: From Year 2008 to Year 2022

  9. First documented confirmed outpatient or any inpatient diagnosis of Urethritis and urethral syndrome in males

    The absolute number of prevalent cases per calendar year will be reported for each outcome. Due to the possibility of multiple infections per person the number of affected individuals will also be reported. The relative frequency will be computed as the proportion of patients which become cases

    Measured: From Year 2008 to Year 2022

  10. Number of male and female participants with documented CT test (screening)

    The absolute number of tests as well as the absolute and relative frequency of tested individuals will be reported

    Measured: From Year 2008 to Year 2022

  11. Number of male and female participants with documented CT tests (diagnostic/curative)

    The absolute number of tests as well as the absolute and relative frequency of tested individuals will be reported

    Measured: From Year 2008 to Year 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start13 Mar 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
81,239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002047
Sponsor's protocol ID
VAV00049
Other IDs
U1111-1320-4648
Status last verified
Apr 2026
First submitted
23 May 2025
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to the study report and the statistical analysis plan. Access to patient-level data cannot be granted due to data protection regulations applicable to the processing of secondary data for health services research. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

An observational study of Chlamydia Trachomatis, run by Sanofi at 1 site in Germany.

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 2 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 4 May 2026. 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 Germany. 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?

Number of female participants with documented (confirmed) outpatient or any inpatient of pelvic inflammatory disease (PID) (time frame: From Year 2008 to Year 2022). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 May 2026.

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