Actively Recruiting
Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data
Led by Sanofi · Updated on 2026-01-26
533000
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Patients with at least one visit within 30 days both before and after their index date
- Age between 14 and 44 years
You will not qualify if you...
- Patients with no documented ICD-10-CM diagnosis for chlamydia who had unknown laboratory test results for chlamydia during the study period
- Patients with an ICD-10-CM diagnosis without a corresponding laboratory test
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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