Chlamydial InfectionsNCT07094373
Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data
An observational study of Chlamydial Infections, run by Sanofi at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 44 years
- Conditions the study is for
- Chlamydial Infections
- How many people
- 4,878,935 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Validation of Diagnostic Codes for Identifying Chlamydial Infections From TriNetX Electronic Health Record Data in the United States
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:
Read more
- 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
- 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:
- 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
- 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
- Medical subject headings
- Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From year 2016 through year 2024
Descriptive analyses of chlamydia patients
Describe demographic characteristics, laboratory testing, and treatment patterns among true positive and false negative chlamydia patients
Measured: From year 2016 through year 2024
Secondary outcomes (2)
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
Measured: From year 2016 through year 2023
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
Measured: From year 2016 through year 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jan 2025
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chlamydial InfectionsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,878,935 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094373
- Sponsor's protocol ID
- VAV19180
- Other IDs
- U1111-1322-6372
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Diagnostic Codes for Identifying Chlamydial Infections From TriNetX Electronic Health Record Data in the United States
- ClinicalTrials.gov ID
- NCT07094373
- Acronym / sponsor ID
- VAV19180
- Conditions
- Chlamydial Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,878,935 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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:
- 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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validity of ICD-10-CM Diagnostic Codes for Chlamydial Infections
Time frame: From year 2016 through year 2024
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
Descriptive analyses of chlamydia patients
Time frame: From year 2016 through year 2024
Describe demographic characteristics, laboratory testing, and treatment patterns among true positive and false negative chlamydia patients
2 secondary outcomes
Validity of CCAE Database for Chlamydial Infections
Time frame: From year 2016 through year 2023
Comparison of chlamydia patient characteristics between EHR and claims RWD sources in the US
Time frame: From year 2016 through year 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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
Related trials for Chlamydial Infections
Not yet recruitingPhase 3
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
Sexually Transmitted Infection (STI), Gonorrhea
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
RecruitingPhase 4
Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
Gonorrhea, Chlamydia
Not yet recruiting
Improving Clinic Delivery of HIV-related Anal Health Services
HIV, Gonorrhea
Not yet recruiting
Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chlamydial Infections, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of ICD-10-CM Diagnostic Codes for Chlamydial Infections (time frame: From year 2016 through year 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.