Chlamydia Trachomatis InfectionNCT03970850
NeuMoDx PrEDiCTiNG Study Evaluation Plan
A study testing NeuMoDx CT/NG Assay and FDA-cleared NAATs in people with Chlamydia Trachomatis Infection and Neisseria Gonorrheae Infection, run by NeuMoDx Molecular, Inc. at 15 sites in United States.
Trial summary
This investigational study will be conducted to evaluate the performance of the NeuMoDx™ CT/NG Assay on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (collectively referred to as NeuMoDx™ CT/NG Assay test system). Read more about this study
- Who is it for?
- Ages 14 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection
- What is being tested?
- NeuMoDx CT/NG Assay and FDA-cleared NAATs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,017 participants
- Where
- 15 sitesUnited States
- Study dates
- 22 Jul 2019to 25 Feb 2020
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects of at least 14 years of age or older.
- Subject must be able and willing to provide informed consent. The use of a 'surrogate' or 'Legally Authorized Representative' is allowed and shall follow the site's standard procedures, under which the clinical investigation will be conducted.
- Subjects undergoing a routine pelvic examination, subjects eligible for screening evaluations for possible STDs and/or subjects known to be partners with a person with a confirmed or suspected STD.
- Subject is willing to provide all required specimens.
Who cannot join
- Female subject reports that she had a hysterectomy.
- Subject self-reports use of antibiotics within 28 days of study enrollment.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
TriCore Reference Labs
Albuquerque, New Mexico, 87505
NeuMoDx Molecular, Inc.
Ann Arbor, Michigan, 48108
University of Alabama
Birmingham, Alabama, 35294
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
MetroHealth Medical Center
Cleveland, Ohio, 44109
Henry Ford Health System (HFHS)
Detroit, Michigan, 48202
Planned Parenthood - Northern, Central and Southern New Jersey
Elizabeth, New Jersey, 07201
Planned Parenthood - Gulf Coast
Houston, Texas, 77023
Indiana University (IU)
Indianapolis, Indiana, 46202
LSU Health Science
New Orleans, Louisiana, 70112
Planned Parenthood - Northern, Central and Southern New Jersey
Newton, New Jersey, 07860
Healthcare Clinical Date, Inc. (Segal Trials)
North Miami, Florida, 33161
Planned Parenthood - Southwest and Central Florida
Orlando, Florida, 32817
Planned Parenthood - Northern, Central and Southern New Jersey
Riverside Park, New Jersey, 08075
Planned Parenthood - Southwest and Central Florida
Tampa, Florida, 33617
About this study
Official title: Multi-Center Clinical Performance Evaluation of the NeuMoDx™ Chlamydia Trachomatis (CT) / Neisseria Gonorrhoeae (NG) [CT/NG] Assay on the NeuMoDx™ 288 Molecular System and the NeuMoDx™96 Molecular System
This investigational study will be conducted to evaluate the performance of the NeuMoDx™ CT/NG Assay on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (collectively referred to as NeuMoDx™ CT/NG Assay test system).
Read the detailed description
Clinical performance characteristics of the NeuMoDx CT/NG Assay on NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System will be evaluated in a multi-center, prospective, sampling study by comparing the diagnoses made by the NeuMoDx™ CT/NG Assay to Patient Infected Status (PIS) as the reference standard.
Prospectively collected urine and swab specimens from individual subjects will be tested using the NeuMoDx™ CT/NG Assay at one of the three NeuMoDx testing sites. Subjects' PIS for CT and PIS for NG will be determined by a central laboratory using FDA-cleared, legally marketed CT/NG combo assays on pre-specified sample matrices according to the PIS determination algorithms.
- Being tested
- NeuMoDx CT/NG Assay, FDA-cleared NAATs
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuMoDx CT/NG AssayDiagnostic test
NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System
FDA-cleared NAATsDiagnostic test
Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs
| Study group | Role | What they receive |
|---|---|---|
| Multi-arm - Symptomatic and Asymptomatic Males | Active comparator | Arm 1 - Urine from males subjects Receives: Diagnostic Test: NeuMoDx CT/NG Assay |
| Multi-arm - Symptomatic and Asymptomatic Females | Active comparator | Arm 2 - Endocervical, self-collected (in the clinical setting) and physician-collected vaginal swabs and urine from female subjects Receives: Diagnostic Test: NeuMoDx CT/NG Assay |
| Multi-arm - FDA cleared NAATs (Comparator) | Active comparator | Arm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs) Receives: Diagnostic Test: FDA-cleared NAATs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical specificity and sensitivity
Clinical specificity and sensitivity of NeuMoDx CT/NG Assay for both CT and NG relative to an individual's patient infected status (PIS)
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Valid results rate
Evaluate indeterminate and unresolved rates
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start22 Jul 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chlamydia Trachomatis InfectionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuMoDx Molecular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970850
- Sponsor's protocol ID
- CTNG-01-18NMD
- Status last verified
- Jun 2020
- First submitted
- 30 May 2019
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Clinical Performance Evaluation of the NeuMoDx™ Chlamydia Trachomatis (CT) / Neisseria Gonorrhoeae (NG) [CT/NG] Assay on the NeuMoDx™ 288 Molecular System and the NeuMoDx™96 Molecular System
- ClinicalTrials.gov ID
- NCT03970850
- Acronym / sponsor ID
- CTNG-01-18NMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,017 participants (actual)
- Lead sponsor
- NeuMoDx Molecular, Inc.Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 3 Jun 2019 (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 investigational study will be conducted to evaluate the performance of the NeuMoDx™ CT/NG Assay on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (collectively referred to as NeuMoDx™ CT/NG Assay test system).
Detailed description
Clinical performance characteristics of the NeuMoDx CT/NG Assay on NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System will be evaluated in a multi-center, prospective, sampling study by comparing the diagnoses made by the NeuMoDx™ CT/NG Assay to Patient Infected Status (PIS) as the reference standard.
Prospectively collected urine and swab specimens from individual subjects will be tested using the NeuMoDx™ CT/NG Assay at one of the three NeuMoDx testing sites. Subjects' PIS for CT and PIS for NG will be determined by a central laboratory using FDA-cleared, legally marketed CT/NG combo assays on pre-specified sample matrices according to the PIS determination algorithms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multi-arm - Symptomatic and Asymptomatic Males | Active comparator | Diagnostic Test: NeuMoDx CT/NG AssayArm 1 - Urine from males subjects |
| Multi-arm - Symptomatic and Asymptomatic Females | Active comparator | Diagnostic Test: NeuMoDx CT/NG AssayArm 2 - Endocervical, self-collected (in the clinical setting) and physician-collected vaginal swabs and urine from female subjects |
| Multi-arm - FDA cleared NAATs (Comparator) | Active comparator | Diagnostic Test: FDA-cleared NAATsArm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs) |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects of at least 14 years of age or older.
- Subject must be able and willing to provide informed consent. The use of a 'surrogate' or 'Legally Authorized Representative' is allowed and shall follow the site's standard procedures, under which the clinical investigation will be conducted.
- Subjects undergoing a routine pelvic examination, subjects eligible for screening evaluations for possible STDs and/or subjects known to be partners with a person with a confirmed or suspected STD.
- Subject is willing to provide all required specimens.
Key exclusion criteria (2 listed)
- Female subject reports that she had a hysterectomy.
- Subject self-reports use of antibiotics within 28 days of study enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuMoDx CT/NG AssayNeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System | Diagnostic test | Multi-arm - Symptomatic and Asymptomatic Females, Multi-arm - Symptomatic and Asymptomatic Males |
| FDA-cleared NAATsTesting swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs | Diagnostic test | Multi-arm - FDA cleared NAATs (Comparator) |
Primary outcome
Clinical specificity and sensitivity
Time frame: Through study completion, an average of 1 year
Clinical specificity and sensitivity of NeuMoDx CT/NG Assay for both CT and NG relative to an individual's patient infected status (PIS)
1 secondary outcome
Valid results rate
Time frame: Through study completion, an average of 1 year
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 12 Jun 2020.
- Individual participant dataSharing planned: No
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuMoDx CT/NG Assay and FDA-cleared NAATs in people with Chlamydia Trachomatis Infection and Neisseria Gonorrheae Infection, run by NeuMoDx Molecular, Inc. at 15 sites 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 4 inclusion and 2 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Clinical specificity and sensitivity (time frame: Through study completion, an average of 1 year). 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 12 Jun 2020.