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Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data

StatusCompleted
PhaseNot specified
SponsorSanofi
Started
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Record History

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  1. Trial completed
    • Final enrollment: 4878935 participants (planned 533000)
    • Site details revised
  2. Primary and study completion pushed from Aug 31, 2026 to Sep 30, 2026
    • Secondary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria expanded, about 4 words
  3. Primary and study completion pushed from Jun 12, 2026 to Aug 31, 2026v3
  4. Primary and study completion dates: Dec 24, 2025 to Jun 12, 2026v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
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
Trial Details
NCT Number NCT07094373
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Chlamydial Infections
Related terms Chlamydia Infections
Enrollment 4,878,935 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov