Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data

Investigation of Chlamydia Diagnostic Codes in Electronic Health Records

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.

This study investigates the use of electronic health records (EHR) data from TriNetX in the US to conduct research on chlamydia, a common sexually transmitted infection. The purpose of this study is to assess whether TriNetX is a suitable source for real-world data to support chlamydia-related research, particularly for programs involving the chlamydia trachomatis (CT) messenger Ribonucleic acid (mRNA) vaccine. The study aims to validate the diagnostic codes used to identify patients with chlamydial infections and to describe testing and treatment patterns.

Participants in this study will have their medical records reviewed to determine the accuracy of the ICD-10-CM codes for chlamydia diagnosis. Additionally, the study will explore the feasibility of developing an algorithm to identify chlamydia cases in another database, the Merative MarketScan Commercial Claims and Encounters (CCAE). The study will also compare patient characteristics and treatment patterns between the TriNetX and MarketScan databases.

  • Who can participate: Adults with a documented ICD-10-CM diagnosis of chlamydia or a nucleic acid amplification test (NAAT) result for chlamydia are eligible. Participants must have had at least one medical visit within 30 days before and after their diagnosis date.
  • Study details: Participants will have their EHR data analyzed to validate the use of diagnostic codes for chlamydia. The study will not involve any changes to their treatment or additional procedures beyond routine care.
Updated on 22 Jan 2026. Study ID: NCT07094373

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