Clinical trials: Chlamydial Infections
Chlamydia Trachomatis, Gonorrhea
Evaluation of the Atlas Genetics io® CTNG System
Atlas Genetics io® system results are compared with those obtained from comparator devices.
- Trial name
- IO-CTNG (NCT03071510)
- Testing
- Atlas Genetics io® system
- Where
- 10 sites in United States
- Volunteers
- 7,128 people, healthy volunteers welcome
- Sponsor
- Binx Health Limited
Chlamydia Trachomatis Immunization
Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years
The purpose of this study is to evaluate the safety, efficacy, and immunogenicity of different dose levels (low, medium, and high) of Chlamydia messenger ribonucleic acid (mRNA) Vaccine candidate in adult participants aged 18 to…
- Trial name
- NCT06891417
- Testing
- Chlamydia mRNA Vaccine
- Where
- 7 sites in Australia
- Volunteers
- 1,560 people, healthy volunteers welcome
- Sponsor
- Sanofi
Chlamydia Trachomatis, Neisseria Gonorrhoeae Infection
Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System
The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and…
- Trial name
- NCT01733069
- Testing
- APTIMA COMBO 2 Assay (AC2 Assay)
- Where
- 7 sites in United States
- Volunteers
- 1,912 people, healthy volunteers welcome
- Sponsor
- Gen-Probe, Incorporated
Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection
Clinical Evaluation of the ID NOW™ CT/NG Test
The objective of this study is to determine the performance of the ID NOW™ CT/NG test in male urine, female urine, and self-collected vaginal swabs when tested by intended users (i.e., untrained operators).
- Conditions
- Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection, Asymptomatic Condition
- Trial name
- NCT06395675
- Testing
- ID NOW™
- Where
- United States
- Volunteers
- 7,100 people, healthy volunteers welcome
- Sponsor
- Abbott Rapid Dx
Chlamydia, Gonorrhea
Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC).
- Trial name
- NCT01167777
- Where
- 7 sites in United States
- Volunteers
- 2,296 people
- Sponsor
- Siemens Healthcare Diagnostics Inc
Uncomplicated Urogenital Gonorrhea
Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea
This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea.
- Trial name
- SOLITAIRE-U (NCT02210325)
- Testing
- solithromycin, ceftriaxone, azithromycin
- Where
- 5 sites in United States, Australia
- Volunteers
- 264 people
- Sponsor
- Melinta Therapeutics, Inc.
Influenza A, Influenza Type B
LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia
To establish the relative accuracy of the LIAISON® NES Flu A/B, RSV \& COVID-19 assay for viral nucleic acid targets from professionally collected or patient self-collected dry nasal (NS) swabs and to establish the relative…
- Conditions
- Influenza A, Influenza Type B, Coronavirus Disease 2019, Respiratory Syncytial Virus (RSV)
- Trial name
- NCT06392451
- Testing
- LIAISON NES FLU A/B, RSV, & COVID-19, LIAISON PLEX Respiratory Flex Assay
- Where
- 4 sites in Australia
- Volunteers
- 1,000 people
- Sponsor
- DiaSorin Molecular LLC
Chlamydia Trachomatis, Gonorrhea
Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples
The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.
- Trial name
- NCT02795975
- Where
- 18 sites in United States
- Volunteers
- 1,766 people, healthy volunteers welcome
- Sponsor
- Hologic, Inc.
Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection
NeuMoDx PrEDiCTiNG Study Evaluation Plan
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…
- Trial name
- NCT03970850
- Testing
- NeuMoDx CT/NG Assay, FDA-cleared NAATs
- Where
- 15 sites in United States
- Volunteers
- 4,017 people, healthy volunteers welcome
- Sponsor
- NeuMoDx Molecular, Inc.
Chlamydia, Gonorrhea
Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views
Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).
- Conditions
- Chlamydia, Gonorrhea, Bacterial Vaginosis, Human Papilloma Virus
- Trial name
- STAMP (NCT06154239)
- Testing
- DAYE Diagnostic Tampon, Vaginal self-swab, Clinician vaginal swab
- Where
- United Kingdom
- Volunteers
- 617 people, healthy volunteers welcome
- Sponsor
- Anne's Day Ltd
Chlamydia Trachomatis
Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System
The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS (Direct Transfer) System ("TIGRIS System"), can…
- Trial name
- NCT01358799
- Testing
- APTIMA Assay for Chlamydia trachomatis
- Where
- 7 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Gen-Probe, Incorporated
Sexually Transmitted Diseases
Clinical Evaluation of Visby Medical Men's Sexual Health Test
This is a multi-center study in which the performance of the Visby Medical Men's Sexual Health Test is evaluated when run by male subjects of 14 years of age and older on self-collected first catch urine samples using the…
- Trial name
- NCT07659808
- Testing
- Visby Medical Men's STI PCR Test Kit
- Where
- 5 sites in United States
- Volunteers
- 507 people, healthy volunteers welcome
- Sponsor
- Visby Medical
Chlamydial Infection, Gonococcal Infection
Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or…
- Conditions
- Chlamydial Infection, Gonococcal Infection, Trichomoniasis
- Trial name
- NCT04098900
- Testing
- Click Sexual Health Test
- Where
- 5 sites in United States
- Volunteers
- 309 people, healthy volunteers welcome
- Sponsor
- Visby Medical
HIV Infections, Gonorrhea
Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5 gels compared to placebo in preventing vaginally acquired HIV infection.
- Conditions
- HIV Infections, Gonorrhea, Chlamydial Infections, Genital Herpes
- Trial name
- NCT00262106
- Testing
- PRO 2000/5
- Where
- 6 sites in South Africa, Tanzania and 2 more
- Volunteers
- 9,404 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Infection
Identigene STD Test Collection Kit Validation Study
The overall goal of the present study is to provide evidence of concordant test results using the Identigene STD Test Collection Kit for self-collection and transport of specimens to a qualified testing laboratory.
- Trial name
- NCT01471392
- Testing
- STD Diagnostic Kit (Identigene)
- Where
- United States
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Identigene
Sexually Transmitted Diseases, Gonorrhea
Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection
- Conditions
- Sexually Transmitted Diseases, Gonorrhea, Chlamydia
- Trial name
- EVOGUARD (NCT04553068)
- Testing
- EVO100
- Where
- 98 sites in United States
- Volunteers
- 1,892 people, healthy volunteers welcome
- Sponsor
- Evofem Inc.
Chlamydia, Gonorrhea
Detection of Chlamydia (CT) and Gonorrhea (NG)
To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10, with male urine, female urine, physician-collected (medical professional) endocervical swabs and self-collected vaginal swabs taken…
- Trial name
- NCT02055742
- Testing
- illumigene CT and NG assays, illumipro-10
- Where
- 3 sites in United States
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Meridian Bioscience, Inc.
Chlamydia Infections, Gonorrhea
Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays
The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.
- Conditions
- Chlamydia Infections, Gonorrhea, Trichomonas Infections
- Trial name
- NCT01728103
- Testing
- APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
- Where
- 14 sites in United States
- Volunteers
- 1,336 people, healthy volunteers welcome
- Sponsor
- Gen-Probe, Incorporated
Chlamydial Infections
Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data
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…
- Trial name
- NCT07094373
- Where
- United States
- Volunteers
- 4,878,935 people
- Sponsor
- Sanofi
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
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)…
- Conditions
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Mycoplasma Genitalium Infection
- Trial name
- NCT06369220
- Testing
- cobas® liat CT/NG/MG nucleic acid test, Standard of Care (SOC): Clinician's Standard Practice
- Where
- 4 sites in United States
- Volunteers
- 331 people
- Sponsor
- Hoffmann-La Roche