Clinical trial NCT07002047: Real World and Epidemiology Study of Medically Attended Chlamydia Trachomatis Among Adults in Germany
Official title: Real World and Epidemiology Study of Medically Attended Chlamydia Trachomatis Among Adults in Germany
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chlamydia Trachomatis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-06-03
Enrollment: 81239
Sex: ALL
Minimum age (years): 14
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and adults aged 14 to 44 years in the years 2008-2022 with documented (confirmed) diagnosis of CT.

Brief 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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of female participants with documented (confirmed) outpatient or any inpatient of pelvic inflammatory disease (PID)
timeFrame: From Year 2008 to Year 2022
measure: Number of female participants with documented confirmed outpatient or any inpatient diagnosis of ectopic pregnancy
timeFrame: From Year 2008 to Year 2022
measure: Number of female participants with documented confirmed outpatient or any inpatient diagnosis tubal factor infertility
timeFrame: From Year 2008 to Year 2022
measure: Number of male participants with documented confirmed outpatient or any inpatient diagnosis of orchitis or epididymitis
timeFrame: From Year 2008 to Year 2022
measure: Number of male participants with documented confirmed outpatient or any inpatient diagnosis of proctitis
timeFrame: From Year 2008 to Year 2022
measure: Number of male participants with documented confirmed outpatient or any inpatient diagnosis of prostatitis
timeFrame: From Year 2008 to Year 2022
measure: Number of male and female participants with documented confirmed outpatient or any inpatient diagnosis of female/male infertility
timeFrame: From Year 2008 to Year 2022
measure: Number of male and female participants with documented confirmed outpatient or any inpatient diagnosis of Urethritis and urethral syndrome
timeFrame: From Year 2008 to Year 2022
measure: Time in days from first documented prevalent CT infection to first documented complication/sequelae diagnosis
timeFrame: From Year 2008 to Year 2022
measure: 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)
timeFrame: From Year 2008 to Year 2022
measure: Number of CT reinfections/episodes
timeFrame: From Year 2008 to Year 2022
measure: Number of male and female participants with documented confirmed outpatient or any inpatient diagnosis of other STI
timeFrame: From Year 2008 to Year 2022
measure: Cost incurred from the number of physician contacts (of any specialty)
timeFrame: From Year 2008 to Year 2022
measure: Costs incurred from the number of hospital admissions
timeFrame: From Year 2008 to Year 2022
measure: Costs incurred for the number of prescriptions filled for any drug
timeFrame: From Year 2008 to Year 2022
measure: Costs incurred for the number of filled prescriptions for any medical aid
timeFrame: From Year 2008 to Year 2022
measure: Costs incurred for the number of physician contacts (of any specialty) related to CT or STI-diagnoses.
timeFrame: From Year 2008 to Year 2022
measure: Costs incurred for the number of hospital admissions related to CT or STI-diagnoses.
timeFrame: From Year 2008 to Year 2022
measure: Costs incurred for the number of filled prescriptions for CT-related antibiotics, dispensed within 30 days after CT diagnosis
timeFrame: From Year 2008 to Year 2022
measure: Costs incurred for the number of filled prescriptions for medical aids related to CT or STI diagnoses
timeFrame: From Year 2008 to Year 2022
measure: Total CT-/STI-unspecific health care costs (inpatient, outpatient, drugs, medical aids)
timeFrame: From Year 2008 to Year 2022
measure: CT-/STI-unspecific outpatient costs
timeFrame: From Year 2008 to Year 2022
measure: CT-/STI-unspecific inpatient costs
timeFrame: From Year 2008 to Year 2022
measure: CT-/STI-unspecific drug cost
timeFrame: From Year 2008 to Year 2022
measure: CT-/STI-unspecific medical aid costs
timeFrame: From Year 2008 to Year 2022
measure: Outpatient costs that are related to cases with a confirmed CT diagnosis
timeFrame: From Year 2008 to Year 2022
measure: Inpatient costs that are related to cases with any CT diagnosis
timeFrame: From Year 2008 to Year 2022
measure: Outpatient costs that are related to cases with any confirmed STI diagnosis
timeFrame: From Year 2008 to Year 2022
measure: Inpatient costs that are related to cases with any confirmed STI diagnosis
timeFrame: From Year 2008 to Year 2022
measure: Costs of potentially CT-relevant antibiotics dispensed up to 30 days after confirmend outpatient or any inpatient CT diagnosis
timeFrame: From Year 2008 to Year 2022
Secondary outcomes:
measure: Confirmed outpatient or any inpatient CT diagnosis
timeFrame: From Year 2008 to Year 2022
measure: Confirmed outpatient or any inpatient of PID (CT associated, or other origin) in females
timeFrame: From Year 2008 to Year 2022
measure: First documented confirmed outpatient or any inpatient diagnosis of ectopic pregnancy in females
timeFrame: From Year 2008 to Year 2022
measure: First documented confirmed outpatient or any inpatient diagnosis tubal factor infertility in females
timeFrame: From Year 2008 to Year 2022
measure: First documented confirmed outpatient or any inpatient diagnosis of orchitis or epididymitis in males
timeFrame: From Year 2008 to Year 2022
measure: First documented confirmed outpatient or any inpatient diagnosis of proctitis in males
timeFrame: From Year 2008 to Year 2022
measure: First documented confirmed outpatient or any inpatient diagnosis of prostatitis in males
timeFrame: From Year 2008 to Year 2022
measure: First documented confirmed outpatient or any inpatient diagnosis of infertility in males
timeFrame: From Year 2008 to Year 2022
measure: First documented confirmed outpatient or any inpatient diagnosis of Urethritis and urethral syndrome in males
timeFrame: From Year 2008 to Year 2022
measure: Number of male and female participants with documented CT test (screening)
timeFrame: From Year 2008 to Year 2022
measure: Number of male and female participants with documented CT tests (diagnostic/curative)
timeFrame: From Year 2008 to Year 2022
Other outcomes:
Locations:
city: Germany
country: Germany
Study officials:
References: