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| ID | Type | Description | Link |
|---|---|---|---|
| UM1AI104681 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| SpeeDx Pty Ltd | INDUSTRY |
| Abbott | INDUSTRY |
| Seegene USA Inc |
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The goal of this study is to learn if a few investigational tests can correctly find the gene mutation (mutant allele gyrA 91F) that predicts ciprofloxacin resistance in clinical specimens that harbor Neisseria gonorrhoeae. The main question the study aims to answer:
Can the investigational reflex test find the correct gene mutation (Neisseria gonorrhoeae gyrA 91F or gyrA 91S) as compared to the sequenced result?
Specimens that are collected for routine clinical care and harbor Neisseria gonorrhoeae will be evaluated in this study.
This is a prospective, multi-center, cross-sectional study using consecutive clinical specimens that are collected for routine clinical care and test positive for N. gonorrhoeae using an FDA-cleared molecular assay. The study evaluates the diagnostic accuracy of multiple investigational reflex tests to detect the mutant allele gyrA 91F that predicts ciprofloxacin resistance in N. gonorrhoeae, as compared to a reference standard of Sanger sequencing of the gyrA codon 91. Specimens will be tested via a reference standard of Sanger sequencing and one investigational reflex test. The target sample size is 311 urine specimens, 496 vaginal swab specimens, and 469 pharyngeal specimens, for each investigational reflex test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urine | Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using urine samples. |
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| Vaginal Swab | Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using vaginal swabs. |
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| Pharyngeal Swabs | Investigational Reflex Test performed to detect the mutant gyrA 91F allele or the wildtype gyrA 91S allele using pharyngeal swabs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Reflex Test 1 | Diagnostic Test | Investigational Reflex Test 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine | Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing. | One day |
| Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in vaginal swabs | Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing. | One day |
| Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in pharyngeal swabs | Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing. | One day |
| Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in urine | Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing. | One day |
| Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in vaginal swabs | Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing. | One day |
| Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in pharyngeal swabs |
| Measure | Description | Time Frame |
|---|---|---|
| Number of invalid results for Investigational Reflex Test 1 in urine | One day | |
| Number of invalid results for Investigational Reflex Test 1 in vaginal swabs | One day | |
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Inclusion Criteria:
Exclusion Criteria:
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Clinical specimens from male and females that test positive for Neisseria gonorrhoeae
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nyssa Schwager, MSN, RN | Contact | 708-217-1146 | nyssa.schwager@duke.edu | |
| Michael J. Satlin, MD, MS | Contact | 434-531-6218 | mjs9012@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael J. Satlin, MD, MS | Weill Medical College of Cornell University | Principal Investigator |
| Jeffrey D. Klausner, MD, MPH | University of Southern California - Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Public Health Laboratory | Recruiting | San Francisco | California | 94102 | United States |
Individual participant data (IPD) including clinical specimen details, investigational testing results, and sequencing results can be shared with other researchers after primary publication. Investigators must apply to the Antibacterial Resistance Group for approval to receive and use the data. Investigators must comply with additional contractual and regulatory obligations.
IPD will be available after the primary publication date. There is not end date for the IPD availability.
Only those who have applied to the ARLG and being approved will be able to access the data.
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| Investigational Reflex Test 2 | Diagnostic Test | Investigational Reflex Test 2 |
|
| Investigational Reflex Test 3 | Diagnostic Test | Investigational Reflex Test 3 |
|
Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing. |
| One day |
| Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in urine | Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing. | One day |
| Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in vaginal swabs | Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing. | One day |
| Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in pharyngeal swabs | Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing. | One day |
| Number of invalid results for Investigational Reflex Test 1 in pharyngeal swabs |
| One day |
| Number of invalid results for Investigational Reflex Test 2 in urine | One day |
| Number of invalid results for Investigational Reflex Test 2 in vaginal swabs | One day |
| Number of invalid results for Investigational Reflex Test 2 in pharyngeal swabs | One day |
| Number of invalid results for Investigational Reflex Test 3 in urine | One day |
| Number of invalid results for Investigational Reflex Test 3 in vaginal swabs | One day |
| Number of invalid results for Investigational Reflex Test 3 in pharyngeal swabs | One day |
| Vance G. Fowler, MD, MHS | Duke University | Study Director |
| Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Mississippi State Department of Public Health | Recruiting | Jackson | Mississippi | 39216 | United States |
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| Corewell Health | Recruiting | Royal Oak | Missouri | 48073 | United States |
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| LabCorp | Recruiting | Durham | North Carolina | 27703 | United States |
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| ARUP Laboratories | Recruiting | Salt Lake City | Utah | 84108 | United States |
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| University of Virginia School of Medicine | Recruiting | Charlottesville | Virginia | 22908 | United States |
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| Molecular Testing Labs | Recruiting | Vancouver | Washington | 98684 | United States |
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| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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