Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data

Using EHR Data for Chlamydia Research

Recruiting
14 years - 44 years
All
Phase N/A
533000 participants needed
1 Location

Study Overview

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chlamydial Infections
  • Age: 14 years - 44 years
  • Gender: All

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.

Updated on 30 Jul 2025. Study ID: NCT07094373

This study investigates the use of electronic health record (EHR) data from TriNetX, a global health research network, to conduct research related to chlamydia. Chlamydia is a common sexually transmitted infection caused by the bacterium Chlamydia trachomatis. The study aims to determine if the TriNetX database is a suitable real-world data source for chlamydia research, particularly in relation to a messenger Ribonucleic acid (mRNA) vaccine program.

Study procedures involve validating the use of ICD-10-CM diagnostic codes to identify patients with chlamydial infections and examining patterns in screening, diagnostic testing, and treatment. Additionally, the study will explore the possibility of creating a modified algorithm for identifying chlamydia cases in another database, the Merative MarketScan Commercial Claims and Encounters (CCAE), based on findings from the primary objectives.

  • Who can participate: Participants must have an ICD-10-CM diagnosis of chlamydia or a nucleic acid amplification test (NAAT) result for chlamydia. They should have at least one visit within 30 days both before and after their index date.
  • Study details: Participants will be identified through their EHR data, focusing on diagnostic codes and test results. The study will assess the validity of these codes and explore treatment and testing patterns.

Find a study site near you

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
United States Only: Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language