Clinical trials: Neisseria Gonorrhoeae
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
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
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
Gonorrhea
Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea
The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated cervical, urethral, rectal, or pharyngeal gonorrhea.
- Trial name
- NCT02015637
- Testing
- Delafloxacin, Ceftriaxone
- Where
- 25 sites in United States
- Volunteers
- 460 people
- Sponsor
- Melinta Therapeutics, 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
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
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
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
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 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
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
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 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, 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
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