Clinical trials: Gonococcal Infection
- Condition Gonococcal Infection
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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.
Gonorrhea, Chlamydia
A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States.
Brief Summary: The main purpose of the study is to learn about how well Trumenba vaccine shot works against gonorrhea infection. This study looks at data records from a database in the United States.
- Conditions
- Gonorrhea, Chlamydia, Meningococcal Vaccines
- Trial name
- NCT05873751
- Testing
- Trumenba Vaccine, MenACWY Vaccine
- Where
- United States
- Volunteers
- 1,307,378 people
- Sponsor
- Pfizer
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 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
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
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
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 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 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
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
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 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, 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
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.
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