Clinical trials: Neisseria Gonorrheae Infection
Chlamydia Infections, Gonorrhea
Prospective Collection of Female and Male Specimens for PANTHER® System Testing
The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs and male first-catch urine and urethral swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® System
- Trial name
- NCT01638637
- Testing
- APTIMA Assays; PANTHER System
- Where
- 16 sites in United States
- Volunteers
- 1,492 people, healthy volunteers welcome
- Sponsor
- Gen-Probe, Incorporated
Gonorrhea
A Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains.
- Trial name
- NCT02294682
- Testing
- GSK2140944
- Where
- 14 sites in United States, Puerto Rico and 1 more
- Volunteers
- 106 people
- Sponsor
- GlaxoSmithKline
Neisseria Gonorrhoeae
Trial to Assess the Efficacy of F598 in Preventing an Experimental Urethral Infection With N. Gonorrhoeae in Healthy Males
Approximately 24 healthy male volunteers between the ages of 18 and 35 years will be enrolled at a single center for a duration of two months for each subject.
- Trial name
- NCT03222401
- Testing
- 1 mg/kg single infusion of F598, 3 mg/kg single infusion of F598, 10 mg/kg single infusion of F598
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Alopexx Pharmaceuticals, LLC
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
Diagnosis, Gonorrhea
Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections
This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples. The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation…
- Conditions
- Diagnosis, Gonorrhea, Resistance Bacterial
- Trial name
- STING (NCT06352554)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- SpeeDx Pty Ltd
Uncomplicated Urogenital Gonorrhea
Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea
To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.
- Trial name
- NCT01591447
- Testing
- solithromycin, Solithromycin (CEM-101)
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Melinta Therapeutics, Inc.
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
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 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
Gonorrhea Infection
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test
The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by…
- Trial name
- NCT07569900
- Testing
- iStatis Gonorrhea Antigen Test
- Where
- 3 sites in South Africa
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
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
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.
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
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.
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
Gonorrhea
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
This is a phase III, randomized, multicenter, open-label study which will be performed to evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of…
- Trial name
- NCT04010539
- Testing
- Gepotidacin, Ceftriaxone, Azithromycin
- Where
- 51 sites in United States, Australia and 4 more
- Volunteers
- 628 people
- Sponsor
- GlaxoSmithKline
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.
Neisseria Gonorrhea
Safety and Immunogenicity Study of a Multivalent Gonorrhoea Vaccine
The main goal of this trial is to evaluate the safety and immunogenicity of the candidate N. gonorrhoeae vaccine, LTB-NG6.
- Trial name
- LTBNG601 (NCT07758972)
- Testing
- LTB-NG6, Sodium Chloride 0.9%
- Where
- Germany
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Sexually Transmitted Diseases
Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age
The aim of this first time in human proof of concept (FTiH-PoC) study was to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized…
- Trial name
- NCT05630859
- Testing
- NgG 12.5 µg investigational vaccine, NgG 25 µg investigational vaccine, NgG 50 µg investigational vaccine
- Where
- 23 sites in United States, Brazil and 6 more
- Volunteers
- 1,009 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gonococcal (GC) Infection
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914
The purpose of this study is to assess the safety and tolerability of orally administered AZD0914 in healthy adult subjects.
- Trial name
- NCT01929629
- Testing
- Part A, Part B
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- AstraZeneca