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

Study Overview

• Status: Completed
• Conditions: Chlamydia Trachomatis

• Study Type: Observational
• Enrollment (Actual): 81239

Contacts and Locations

Study Locations

• Germany
  • Germany, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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 Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: May 23, 2025
• First Submitted That Met QC Criteria: May 23, 2025
• First Posted (Actual): June 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Chlamydia Infections
• Other Study ID Numbers: VAV00049; U1111-1320-4648 (Other Identifier: WHO ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No