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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1320-4648 | Other Identifier | WHO ICTRP |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male and Female Adolescents and Adults with CT | Male and Female patients aged between 14 and 44 years of age with documented (confirmed) CT diagnosis |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Year 2008 to Year 2022 |
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Inclusion Criteria:
Exclusion Criteria:
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Adolescents and adults aged 14 to 44 years in the years 2008-2022 with documented (confirmed) diagnosis of CT.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germany | Germany |
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
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| From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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. | From Year 2008 to Year 2022 |
| 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. | From Year 2008 to Year 2022 |
| 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. | From Year 2008 to Year 2022 |
| Cost incurred from the number of physician contacts (of any specialty) | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| Costs incurred from the number of hospital admissions | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| Costs incurred for the number of prescriptions filled for any drug | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| Costs incurred for the number of filled prescriptions for any medical aid | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| Total CT-/STI-unspecific health care costs (inpatient, outpatient, drugs, medical aids) | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| CT-/STI-unspecific outpatient costs | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| CT-/STI-unspecific inpatient costs | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| CT-/STI-unspecific drug cost | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| CT-/STI-unspecific medical aid costs | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| Outpatient costs that are related to cases with a confirmed CT diagnosis | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| Inpatient costs that are related to cases with any CT diagnosis | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| Outpatient costs that are related to cases with any confirmed STI diagnosis | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| Inpatient costs that are related to cases with any confirmed STI diagnosis | Costs are summed up per patient for the specified follow-up time | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |
| 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 | From Year 2008 to Year 2022 |