A Study of the Clinical Utility of Point of Care Cobas® Liat CT/NG/MG Nucleic Acid Test Versus Current Standard Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 8
- 主要终点
- Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sexually active people
- •People seeking medical services for symptoms consistent with a sexually transmitted infection (STI) and/or known exposure to an STI
排除标准
- •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)
研究组 & 干预措施
Standard of Care (SOC) Arm: Standard Practice
In the SOC arm, the clinician will evaluate the participant based on standard practice.
干预措施: Standard of Care (SOC): Clinician's Standard Practice (Other)
Point of Care (POC) Arm: cobas® liat CT/NG/MG
In the POC arm, the clinician will evaluate the participant and will be provided POC test results upon which they may choose to base their clinical decisions.
干预措施: cobas® liat CT/NG/MG nucleic acid test (Diagnostic Test)
结局指标
主要结局
Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG)
时间窗: 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.
次要结局
- Mean Satisfaction and Confidence Rating Scores of SOC and POC, According to Healthcare Professionals' Responses to the CSDT Questionnaire(Once every 2 weeks until end of study (approximately 4 months))
- Mean Satisfaction Rating Scores of SOC and POC, According to Participants' Responses to the PSDT Questionnaire(On the day of the medical encounter (Day 1))
- Percentage of Participants Given Inappropriate Treatment for CT Infection(On the day of the medical encounter (Day 1))
- Percentage of Participants Given Inappropriate Treatment for NG Infection(On the day of the medical encounter (Day 1))
- Percentage of Participants Given Inappropriate Treatment for MG Infection(On the day of the medical encounter (Day 1))