NCT07094373

Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data

Validation of Diagnostic Codes for Identifying Chlamydial Infections From TriNetX Electronic Health Record Data in the United States

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 533,000 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 14 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

This study is a pharmacoepidemiologic method study based on the secondary use of pre-existing data that examines whether TriNetX, a global health research network encompassing a worldwide electronic health record (EHR), database in the US is an appropriate real-world data (RWD) source for conducting chlamydia-related research to support the chlamydia trachomatis (CT) messenger Ribonucleic acid (mRNA) vaccine program. There are two primary objectives for this study: 1. To determine the validity of ICD, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic codes to identify patients with chlamydial infections using TriNetX EHR data in the US 2. To describe screening or diagnostic testing and treatment patterns in patients with chlamydia using TriNetX EHR data in the US There are also two secondary objectives for this study: 1. To explore the feasibility of developing a modified algorithm for identifying patients with chlamydia applicable for Merative MarketScan Commercial Claims and Encounters (CCAE) database based on the findings from the primary objectives 2. To compare patient characteristics, use of screening or diagnostic testing, and treatment patterns among patients with chlamydia between TriNetX EHR data and the MarketScan CCAE data in the US

Conditions

• Chlamydial Infections

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-06-12
• Completion: 2026-06-12
• First posted: 2025-07-30
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States