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Completed

NCT Number: NCT07002047

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

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.

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

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Key information

Conditions

Chlamydia Trachomatis

Age range

14 year–44 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. 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 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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

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

  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)

    Time frame: From Year 2008 to Year 2022

    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.

  11. Number of CT reinfections/episodes

    Time frame: From Year 2008 to Year 2022

    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.

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

    Time frame: From Year 2008 to Year 2022

    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.

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

    Time frame: From Year 2008 to Year 2022

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

  14. Costs incurred from the number of hospital admissions

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

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

  22. CT-/STI-unspecific outpatient costs

    Time frame: From Year 2008 to Year 2022

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

  23. CT-/STI-unspecific inpatient costs

    Time frame: From Year 2008 to Year 2022

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

  24. CT-/STI-unspecific drug cost

    Time frame: From Year 2008 to Year 2022

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

  25. CT-/STI-unspecific medical aid costs

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

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

Secondary outcomes

  1. Confirmed outpatient or any inpatient CT diagnosis

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

    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

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

    Time frame: From Year 2008 to Year 2022

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

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

    Time frame: From Year 2008 to Year 2022

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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