Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data

Sanofi

Status: Enrolling

Conditions: Chlamydial Infections

Study type: Observational

Funder types: Industry

Identifiers

NCT07094373

U1111-1322-6372 (Other Grant/Funding Number)

VAV19180

Details and patient eligibility

About

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

Enrollment: 533,000 estimated patients

Sex: All

Ages: 14 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Primary Objectives:

• Patients with an ICD-10-CM diagnosis of chlamydia documented in their EHR OR patients with a nucleic acid amplification test (NAAT) result for chlamydia (either positive or negative) during the study period. The index date is the date of the first-recorded diagnosis code, or the date of the first-recorded NAAT result when no diagnosis code for chlamydia exists.
• Patients with at least one visit within 30 days both before and after their index date.

Exclusion Criteria for Primary Objectives:

• Patients with no documented ICD-10-CM diagnosis for chlamydia who possessed unknown laboratory test results for chlamydia during the study period (removed from ICD validation assessment in primary analysis).
• Patients with an ICD-10-CM diagnosis without a corresponding laboratory test (removed from ICD validation assessment in primary analysis).

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial design

533,000 participants in 3 patient groups

Cohort 1 (primary objective)

Description:

Patients aged 14 to 44 years with an ICD-10-CM diagnosis of chlamydia documented in their EHR OR patients with a NAAT result for chlamydia (either positive or negative) during the study period (2016-2024) from the TriNetX USA Network

Cohort 2 (secondary objective)

Description:

Patients aged 14 to 44 years with ≥1 ICD-10-CM diagnosis code for chlamydia between 2016 - 2023 in the MarketScan Commercial Claims and Encounters (CCAE) database

Cohort 3 (secondary objective)

Description:

Patients aged 14 to 44 years with ≥1 ICD-10-CM diagnosis code for chlamydia or a positive NAAT result for chlamydia between 2016 -2024 in TriNetX Dataworks USA