Recruiting

Chlamydia Research

Sponsor:

Sanofi

Code:

NCT07094373

Conditions

Chlamydial Infections

Eligibility Criteria

Sex: All

Age: 14 - 44

Healthy Volunteers: Not accepted

Study Details

Brief 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

Study ID

NCT07094373

Start date

Jan 1, 2025

Status verified date

Jul, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 44

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

533000 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1 (primary objective)

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)

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)

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

Primary outcome measure

  • Validity of ICD-10-CM Diagnostic Codes for Chlamydial Infections [ Time Frame: From year 2016 through year 2024 ]
  • Descriptive analyses of chlamydia patients [ Time Frame: From year 2016 through year 2024 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

University of Massachusetts Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

More Information

Sponsor

Sanofi

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanofi on 2026-07-10.