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

NCT ID: NCT07002047

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 81239 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-13
• Study Completion Date: 2026-02-17

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

Conditions

Chlamydia Trachomatis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Germany, , Germany

Countries

Germany

Other Identifiers

U1111-1320-4648

Identifier Type: OTHER

Identifier Source: secondary_id

VAV00049

Identifier Type: -

Identifier Source: org_study_id