Clinical trials: Neisseria Gonorrheae Infection
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
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.
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
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 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
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
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
A Study Evaluating Efficacy and Safety of CRO-SBT in the Treatment of Gonorrhea
This is a phaseIV, multicenter, open-label，single arm study which will be performed to evaluate efficacy and safety of Ceftriaxone sodium and Sulbactam Sodium for injection for the treatment of uncomplicated urogenital infection…
- Trial name
- CRO-SBT (NCT04202068)
- Testing
- Ceftriaxone sodium and Sulbactam Sodium for injection
- Volunteers
- 113 people
- Sponsor
- Xiangbei Welman Pharmaceutical Co., Ltd
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
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 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 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, 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
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.
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
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
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
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.