Chlamydia Trachomatis Infection, Mycoplasma Genitalium Infection, Neisseria Gonorrhoeae Infection
Conditions
Keywords
Sexually transmitted infections, Urogenital infections, Point of care testing
Brief summary
This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG).
Detailed description
The study is designed as a block randomized, controlled 2-arm prospective study. The study targets to enroll approximatively 348 participants at increased risk of sexually transmitted infections (STIs)-participants who have known contact with CT/NG/MG (including participants who report knowledge or suspicion of STI exposure, despite the uncertainty of the specific STI pathogen or contact testing results), or participants with symptoms suggestive of STI-to participate in this study. Participants who give consent will provide demographic information and urogenital specimen(s) for CT/NG/MG testing on the cobas® liat system and for external laboratory-polymerase chain reaction (EL-PCR) testing. Participants will be randomized in a 1:1 ratio in blocks (of multiples of 2) stratified by the site to either of the following arms: * Standard of Care (SOC) * Point of Care (POC) In both arms, the clinician will see and evaluate the participant and will complete a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter. The critical difference between the arms is that the clinician in the POC arm will be provided POC test results upon which they may choose to base their clinical decisions, whereas the SOC arm will not receive POC test results.
Interventions
DIAGNOSTIC_TESTcobas® liat CT/NG/MG nucleic acid test
The cobas® CT/NG/MG nucleic acid test for use on the cobas® Liat® System is an investigational, automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) nucleic acid in male/female urine and vaginal swabs (clinician-collected and self-collected) in cobas® PCR Media.
OTHERStandard of Care (SOC): Clinician's Standard Practice
Standard of care (SOC) is defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing.
Sponsors
Hoffmann-La Roche
Roche Molecular Systems, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sexually active people * People seeking medical services for symptoms consistent with a sexually transmitted infection (STI) and/or known exposure to an STI
Exclusion criteria
* Previously enrolled in the study * Unable to provide informed consent * Currently pregnant * Declines POC testing * Presents for routine STI screening (asymptomatic) * Use of antimicrobial agents active against CT, NG, or MG during the 21 days before sample collection. Example of such antimicrobial agents include the following: Macrolides (e.g., azithromycin and erythromycin); Penicillins (e.g., amoxicillin); Tetracyclines (e.g., doxycycline); Fluoroquinolones (e.g., ciprofloxacin, ofloxacin, levofloxacin, and moxifloxacin); Cephalosporins (e.g., ceftriaxone and cefixime) * Use of phenazopyridine-containing urinary pain relief medicines (ie, Azo or Pyridium) within 2 days prior to sample collection * Use of any over-the-counter feminine hygiene products (internally or externally), such as vaginal moisturizers, lubricants (e.g., Replens, RepHresh, etc.), and feminine washes/vaginal douches, etc. within the 3 days prior to sample collection. The use of tampons or pads during menses is not an exclusionary criterion. * Contraindication to vaginal swab sampling where vaginal swab sampling is the only option available * Urination within 1 hour prior to sample collection (for subjects providing urine sample)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG) | On the day of the medical encounter (Day 1) | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on the CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Given Inappropriate Treatment for CT Infection | On the day of the medical encounter (Day 1) | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. |
| Percentage of Participants Given Inappropriate Treatment for NG Infection | On the day of the medical encounter (Day 1) | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. |
| Percentage of Participants Given Inappropriate Treatment for MG Infection | On the day of the medical encounter (Day 1) | An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination. |
| Percentage of Clinicians With Satisfaction Scores for SOC and POC According to the Clinician Satisfaction With Diagnostic Test Questionnaire (CSDT-Q) | Baseline until end of study (approximately 9.9 months) | The CSDT- Questionnaire assessed satisfaction with the test and SOC based on responses to the following: ease of use, time taken to perform, speed of results, ease of result interpretation, impact on the care plan, impact on consultations, impact on workload/workflow, and guidance and training, using a 5-point scale ranging from very satisfied to very dissatisfied. Only response categories with non-zero values are reported. Percentages have been rounded off. |
| Percentage of Clinicians With Confidence Scores for SOC and POC According to the CSDT-Q | Baseline until end of study (approximately 9.9 months) | The CSDT- Questionnaire assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off. |
| Percentage of Participants With Satisfaction Scores for SOC and POC According to the Patient Satisfaction With Diagnostic Test Questionnaire (PSDT-Q) | On the day of the medical encounter (Day 1) | The PSDT- Questionnaire assessed satisfaction with the diagnostic test process based on responses to the following: overall visit satisfaction, information provision, ease of completion, time taken to perform, speed of results, method of results delivery, ease of understanding, accuracy, impact on clinical pathway, overall satisfaction, and satisfaction with sample or measurement collection bases on as: comfort, convenience, type of sample or measurement, person collecting sample or measurement, hygiene using a 5-point scale ranging from very satisfied to very dissatisfied. Percentages have been rounded off. |
| Percentage of Participants With Confidence Scores for SOC and POC According to the PSDT-Q | Baseline until end of study (approximately 9.9 months) | The PSDT-Q assessed confidence in accuracy of the tests (POC and SOC), using a 5-point scale ranging from very confident to very unconfident. Only response categories with non-zero values are reported. Percentages have been rounded off. |
Countries
United States
Contacts
STUDY_DIRECTORZune Huynh, MD
Hoffmann-La Roche
Participant flow
Recruitment details
A total of 331 participants at increased risk of sexually transmitted infection (STIs) who have known contact with Liat Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG)/ Mycoplasma genitalium (MG) or participants with symptoms suggestive of STI took part in the study at 4 sites in the United States of America from 29 July 2024 to 28 May 2025. One participant was excluded from analysis due to invalid results.
Pre-assignment details
The clinicians referred to as any health care professional (e.g., doctor, provider, pharmacist, nurse, etc.) involved with performing diagnostic tests on participants, interpreting the results, and providing participant care were not enrolled in the study. No participant flow/baseline/safety data was collected for the clinicians. The clinician only completed the Clinician Satisfaction with Diagnostic Test Questionnaire (CSDT-Q).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 10.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 66 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 26 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants |
| Race (NIH/OMB) More than one race | 21 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 140 Participants |
| Sex: Female, Male Female | 198 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 160 | 0 / 170 |
| other Total, other adverse events | 0 / 160 | 0 / 170 |
| serious Total, serious adverse events | 0 / 160 | 0 / 170 |
Outcome results
None listed