Real World and Epidemiology Study of Medically Attended Chlamydia Trachomatis Among Adults in Germany
2 other identifiers
observational
81,239
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2025
CompletedFirst Submitted
Initial submission to the registry
May 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 4, 2026
April 1, 2026
10 months
May 23, 2025
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (30)
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
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
Secondary Outcomes (11)
Confirmed outpatient or any inpatient CT diagnosis
From Year 2008 to Year 2022
Confirmed outpatient or any inpatient of PID (CT associated, or other origin) in females
From Year 2008 to Year 2022
First documented confirmed outpatient or any inpatient diagnosis of ectopic pregnancy in females
From Year 2008 to Year 2022
First documented confirmed outpatient or any inpatient diagnosis tubal factor infertility in females
From Year 2008 to Year 2022
First documented confirmed outpatient or any inpatient diagnosis of orchitis or epididymitis in males
From Year 2008 to Year 2022
- +6 more secondary outcomes
Study Arms (1)
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
Eligibility Criteria
Adolescents and adults aged 14 to 44 years in the years 2008-2022 with documented (confirmed) diagnosis of CT.
You may qualify if:
- Either male or female is documented as gender in base data
- At cohort entry, a patient must be aged between 14 and 44 years
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Unknown Facility
Germany, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2025
First Posted
June 3, 2025
Study Start
March 13, 2025
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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