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
Gonococcal Infection
Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)
This is a Phase 1, interventional, non-randomized, experimental infection model study in healthy adult males (N=up to 25) between the ages of 18-35 at study enrollment.
- Trial name
- NCT04870138
- Testing
- Azithromycin, Ceftriaxone, Ciprofloxacin
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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.
Sexually Transmitted Infection, HIV/AIDS
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes.
- Conditions
- Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness, Birth Outcomes
- Trial name
- NCT04446611
- Testing
- First antenatal care + test-of-cure, First antenatal care + week 30-34 gestation (no test-of-cure)
- Where
- South Africa
- Volunteers
- 2,247 people, healthy volunteers welcome
- Sponsor
- Foundation for Professional Development (Pty) Ltd
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
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT
The purpose of this study was to use participant samples to simultaneously evaluate three nucleic acid amplification tests (NAATs) diagnostic platforms.
- Conditions
- Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection, Sexually Transmitted Infections
- Trial name
- pNAAT (NCT02870101)
- Testing
- Nucleic acid amplification test 1 for NG and CT, Nucleic acid amplification test 2 for NG and CT, Nucleic acid amplification test 3 for NG and CT
- Where
- 9 sites in United States
- Volunteers
- 2,767 people, healthy volunteers welcome
- Sponsor
- Duke University
HIV Infections, HIV/AIDS
Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP
This is a randomized clinical trial of doxycycline post-exposure prophylaxis (dPEP) to reduce bacterial STIs among Kenyan women taking pre-exposure prophylaxis (PrEP).
- Conditions
- HIV Infections, HIV/AIDS, Neisseria Gonorrheae Infection, Chlamydia Trachomatis Infection
- Trial name
- dPEP-KE (NCT04050540)
- Testing
- Doxycycline
- Where
- Kenya
- Volunteers
- 449 people, healthy volunteers welcome
- Sponsor
- University of Washington
Neisseria Gonorrhoeae Infection
Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
The purpose of this study is to test whether the group B meningitis vaccine (brand name Bexsero™) induces immune responses against the bacteria that causes gonorrhea.
- Trial name
- 4CMenB (NCT04094883)
- Testing
- Meningococcal Group B Vaccine
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Chlamydial Infection, Gonorrhoea
Clinical Study of a Single-Use, Point-of-Care Molecular Diagnostic Device for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) Utilizing Vaginal Swabs
This is a multi-center study with a minimum of three sites in the United States. The study will enroll approximately 1750 female subjects and will have a study duration of approximately 9 months after enrollment of the first…
- Conditions
- Chlamydial Infection, Gonorrhoea, Trichomoniasis
- Trial name
- NCT03596151
- Testing
- Click Device
- Where
- 8 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gonorrhoea
Efficacy of Combination Therapies for Gonorrhea Treatment
The purpose of this study is to learn how to better treat gonorrhea infections. Gonorrhea is a sexually transmitted disease (STD) that is usually cured with a single antibiotic.
- Trial name
- NCT00926796
- Testing
- Azithromycin, Gentamicin, Gemifloxacin
- Where
- 5 sites in United States
- Volunteers
- 614 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chlamydial Infection, Gonococcal Infection
Clinical Study of a Diagnostic Device for NG, TV and CT in Women
This is a multi-center study with a minimum of three sites in the United States. The study will enroll approximately 1750 female subjects, 14 years of age and older, and will have a study duration of approximately 9 months after…
- Conditions
- Chlamydial Infection, Gonococcal Infection, Trichomoniasis
- Trial name
- NCT03852316
- Testing
- Click Device
- Where
- 10 sites in United States
- Volunteers
- 1,585 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chlamydia Infection, Gonococcal Infection
Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM]
Julius Schachter, PhD, (Department of Laboratory Medicine, University of California, San Francisco) and Susan S. Philip, MD MPH (Department of Medicine, University of California, San Francisco) are conducting a study to evaluate…
- Conditions
- Chlamydia Infection, Gonococcal Infection, Sexually Transmitted Diseases
- Trial name
- NCT01291264
- Where
- 2 sites in United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Chlamydia Trachomatis Infection, Neonatal Infection
Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on…
- Conditions
- Chlamydia Trachomatis Infection, Neonatal Infection, Preterm Birth, Gonorrhea
- Trial name
- NCT04955717
- Testing
- Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
- Where
- 2 sites in United States, Botswana
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Southern California
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.
Gonorrhoea
Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination
This is a Phase 2 mechanistic clinical trial to assess the systemic and mucosal immunogenicity of the multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero (R)) (group 1, 40 subjects) against Neisseria gonorrhoeae…
- Trial name
- NCT04722003
- Testing
- Meningococcal Group B Vaccine
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Gonococcal Infection
Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae
This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrase A (gyrA) serine 91 genotype Neisseria gonorrhoeae (N.
- Trial name
- NCT02961751
- Testing
- Ciprofloxacin
- Where
- 9 sites in United States
- Volunteers
- 211 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
GonoScreen: Efficacy of Screening STIs in MSM
A Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3x3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs.
- Trial name
- GonoScreen (NCT04269434)
- Testing
- No Screening
- Where
- 5 sites in Belgium
- Volunteers
- 1,014 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
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, 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