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CompletedNCT07094373Updated Oct 13, 2026

Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data

An observational study in Chlamydial Infections, sponsored by Sanofi. Completed at 1 site in United States. Open to participants aged 14 Years to 44 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Sanofi · Observational

Updated Oct 13, 2026Now CompletedEnrollment updatedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
4,878,935
Ages
14 Years to 44 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 79 studies in Chlamydia Infections with a site in United States — 8 open to participants now, 8 under way, none of them phase 3. Chlamydia Infections · United States.

Enrollment
Largest of 22
4,878,935 · median 373
Started
2025
with 2 others
Observational
22 of 79
none open now
Registered
77th of 79
by date

Among the 79 studies in Chlamydia Infections with a site in United States, this one has the largest enrollment of the 22 observational ones, is one of 3 that started in 2025, is one of 22 observational ones, and was the 77th registered.

By phase

79 studies; the count open now beside each. This study's row is marked.

No phase31 · 6 open
Observationalthis study22 · 0 open
Phase 39 · 0 open
Phase 49 · 2 open
Phase 26 · 0 open
Phase 1/22 · 0 open

By the year they started

First in 1999; this study’s year is marked. 3 started in 2025.

Size and results

Median enrollment 511 across the 56 interventional studies, 373 across the 22 observational. Of the 67 that completed or were terminated, 21 (31%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 79 studies in Chlamydia Infections with a site in United States, or all of them as a file.
02

Study 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
03

Conditions studied

  • Chlamydial Infections

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04

Who can participate

Ages eligible
14 Years to 44 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

For the primary objectives, the study population will include patients aged 14 to 44 years old identified between 1 January 2016 and 31 October 2024 in TriNetX USA Network. Patients are eligible if they have at least one ICD-10-CM diagnosis code for chlamydia or a known Nucleic Acid Amplification Test (NAAT) result.

For the secondary objectives, the study population includes 1.) patients aged 14 to 44 years with at least one ICD-10-CM diagnosis code for chlamydia between 1 February 2016 and 30 November 2023 in the MarketScan CCAE database and 2.) patients aged 14 to 44 years with an ICD-10-CM diagnosis code for chlamydia or a positive NAAT result for chlamydia between 1 January 2016 and 31 October 2024 in TriNetX Dataworks USA.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
4,878,935 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Validity of ICD-10-CM Diagnostic Codes for Chlamydial Infections

    Diagnostic performance of ICD-10-CM codes for chlamydial infections, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), compared to Nucleic Acid Amplification Test (NAAT) results for chlamydial infections

    Time frame: From year 2016 through year 2024

  2. Descriptive analyses of chlamydia patients

    Describe demographic characteristics, laboratory testing, and treatment patterns among true positive and false negative chlamydia patients

    Time frame: From year 2016 through year 2024

Secondary outcomes

  1. Validity of CCAE Database for Chlamydial Infections

    Detect chlamydia cases using a mix of diagnostic codes, lab test codes, treatments, to detect/confirm chlamydia infection

    Time frame: From year 2016 through year 2023

  2. Comparison of chlamydia patient characteristics between EHR and claims RWD sources in the US

    Compare demographics and clinical features (e.g., age, sex, treatment history, comorbidities) of chlamydia patients as seen in EHRs which contain clinical notes, lab results, and detailed medical histories and claims data

    Time frame: From year 2016 through year 2024

07

Study locations

1 site
  • University of Massachusetts Medical School
    Worcester, Massachusetts 01655, United States
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2025 to primary completion in Sep 2026, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2025
First posted
Jul 30, 2025
StartActual
Jan 1, 2025
Primary completionActual
Sep 30, 2026
CompletionActual
Sep 30, 2026
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 13, 2026
Enrollment
533000 (estimated)→4878935 (actual)
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Recruiting→Completed
    Enrollment 533000 (estimated)→4878935 (actual)
    + 4 other changes: verification date, date precision, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07094373
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Jul 30, 2025
Start date
Jan 1, 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026
Last update
Oct 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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