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Gonorrhea clinical trials

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NCT ID: NCT05971550 Not yet recruiting - Clinical trials for Neisseria Gonorrhoeae Infection

Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study

PORTAPHAR
Start date: September 2023
Phase: Phase 3
Study type: Interventional

Since the use of antibiotics, Neisseria Gonorrhoeae (NG) has acquired progressive resistance to penicillins, sulfonamides, tetracyclines and quinolones. The oropharynx is recognized as an important site for DNA exchange between NG and other commensal Neisseria, allowing NG to acquire new antimicrobial resistance. Despite the worrying data on the emergence of resistant NG, the recommendations remain to systematically treat these infections with ceftriaxone, including asymptomatic pharyngeal localizations. The objective of our study is to evaluate a ceftriaxone sparing strategy in order to limit the emergence of antibiotic resistance. The primary objective of the study is to evaluate the clearance of Neisseria gonorrhoeae, 3 months after the diagnosis of asymptomatic pharyngeal carriage documented on nucleic acid amplification test (NAAT).

NCT ID: NCT05873751 Recruiting - Gonorrhea Clinical Trials

A Study to Learn About How Trumenba Vaccine Shots Work Against Gonorrhea Infection in Teenagers and Young Adults in the United States.

Start date: April 24, 2023
Phase:
Study type: Observational

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. This study includes patient's data from the database who: - Are 15-30 years old. - Have received at least one dose of Trumenba and a MenACWY vaccine or who have received only MenACWY vaccine. - Have enough months of data in the database. This data has already been collected in the past and is being studied between April and June of 2023.

NCT ID: NCT05872438 Recruiting - Clinical trials for Sexually Transmitted Infection

Evaluation of Multisite Sampling to Detect C. Trachomatis or N. Gonorrheae Compared With Vaginal Sampling in Women at Risk for Sexually Transmitted Infections

SIST'RS
Start date: April 14, 2023
Phase: N/A
Study type: Interventional

Screening for STIs in MSM is based on multisite samples: urine, anal and oral for PCR targeting C. trachomatis, N. gonorrhoeae, M. genitalium and T. vaginalis, whereas only vaginal self-sampling is recommended in women. Recent publications and observations suggest that a substantial number of STIs are under diagnosed with the current recommendations. The main objective of the study is to assess the number and percentage of additional C. trachomatis and N. gonorrhoeae infections diagnosed by a multiple sampling strategy in women, particularly when the vaginal sampling is negative The secondary objective will assess the acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women.

NCT ID: NCT05870098 Recruiting - Gonorrhea Clinical Trials

Meatal Swab Yourself With Testing for Infections Collectively

MYSTIC
Start date: July 18, 2023
Phase: N/A
Study type: Interventional

The goal of this study is 1. to improve the accuracy of chlamydia multi-site testing in men who have sex with men (MSM) and trans-women, whilst saving diagnostic costs, by comparing two new pooling methods with the 3-samples tested separately 2. to assess the diagnostic accuracy of pooled specimens for lymphogranuloma venereum detection (LGV) - a type of chlamydia infection Chlamydia and gonorrhoea testing for MSM and trans-women usually involves 3 samples from the throat, bum and wee-pipe. The tests can be combined into a single sample pot (pooled sample) which reduces costs, but in a previous study this reduced the accuracy for finding chlamydia. The main question for this study is: Can the accuracy of chlamydia testing in a pooled sample be improved by reducing the amount of urine added to minimise dilution, or by using a meatal sample instead of a urine sample? Participants will be asked to complete two sets of their own throat and bum samples, and then combine these into two pooled samples with 1)a meatal swab and 2)a smaller amount of first catch urine. The order of these samples will be randomised. These samples will be compared against separate samples taken at the same visit, to see how accurate the pooled samples are at diagnosing chlamydia and gonorrhoea with the different sampling techniques.

NCT ID: NCT05766904 Recruiting - Gonorrhea Clinical Trials

Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections

Start date: May 4, 2023
Phase: Phase 3
Study type: Interventional

Objectives: Efficacy of a meningococcal vaccine against Neisseria gonorrhoea (NG) infection among men who have sex with men (MSM). Design: Parallel randomised double-blind placebo-controlled trial. Setting: A teaching hospital in Hong Kong. Participants: 150 adult MSM at risk of gonorrhoea infection (condomless sex with more than one man within the last six months, history of sexually transmitted infection [STI] diagnosis, inclination to have condomless sex, and other PrEP-eligible criteria) would be recruited into the trial, with half allocated to intervention and control group each. Intervention: Intervention and control group would receive, one month apart, two doses of meningococcal vaccine and normal saline, respectively. Main outcome measures: Safety and efficacy of vaccine against gonorrhoea (time to first gonorrhoea infection and incidence), and behavioural change after vaccination. Expected results: NG incidences in two groups would be compared. Efficacy of vaccine against gonorrhoea would be determined after controlling confounding variables. Characteristics of participants with incident NG would be distinguished from those without incident infections. Change of frequency of sexual activities and networking would be noted. Implications: Strategies on STI screening and vaccination could be informed. Reduced STI burden post-vaccination could be measured with surveillance system.

NCT ID: NCT05727033 Not yet recruiting - Gonorrhea Clinical Trials

Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections

FEDE-ITS
Start date: March 2023
Phase: N/A
Study type: Interventional

Project FEDE-ITS will improve the STI knowledge and its treatment, of adolescents in the 1st and 2nd year of compulsory secondary education in the intervention group compared to compared to the control group, and will modify the sexual risk practices and the perception of risky practices of alcohol and other drug use during sex of participants in the intervention group compared to the control group.

NCT ID: NCT05723263 Recruiting - Gonorrhea Clinical Trials

Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

PIONEER is a three-arm, programmatic cluster randomized controlled trial (RCT) to compare effectiveness of three implementation strategies, followed by a mixed-methods implementation evaluation study

NCT ID: NCT05678556 Recruiting - Hiv Clinical Trials

Effectiveness of Relationship Education for Reducing HIV Incidence Among SGM

all2GETHER
Start date: December 15, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to upgrade an existing relationship education and HIV prevention program. This program is designed for gay, bisexual, queer, and transgender and non-binary people who partner with cisgender men. This means the program is designed for gay, bisexual and queer men, including both cisgender and transgender men. It is also designed for transgender and non-binary people who partner with cisgender men, including both transfeminine and transmasculine people. The investigators aim to test the effectiveness of this updated program among couples and single people. Participants will complete online surveys and get tested for Chlamydia and Gonorrhea. Participants will be tested for urethral and rectal Chlamydia and Gonorrhea. Participants will also complete at-home point-of-care HIV testing, with confirmatory testing for preliminary positive results. They will also participate in our program on relationship education and HIV prevention. Study staff will follow up with participants for up to 2 years. All participants will be randomized into one of two different conditions: the all2GETHER program or no program. "Randomized" means that it is completely up to chance which condition participants will be put into. Participants have a 50% chance of being assigned to either condition, similar to a coin toss. Participants should expect that they will be in this research study for 2 years. Participation in this study will be done remotely - participants will never need to come into a research lab.

NCT ID: NCT05666778 Recruiting - Bacterial Vaginosis Clinical Trials

Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs

POWWERHealth
Start date: February 13, 2023
Phase: Phase 2
Study type: Interventional

HIV remains a global pandemic with 37 million infected. In western Kenya, 16% of women in the general population and 29% of the poorest women have HIV. The HIV and sexually transmitted infection (STI) epidemics overlap with broader reproductive health concerns. Menstrual hygiene management is a big problem in low- and middle-income countries and a lack of menstrual products negatively impacts women's work-life. This comes from cultural taboos, stigma, and discrimination, promoting secrecy around menstruation, high cost of menstrual products, use of traditional materials (e.g. rags, cotton wool, etc.) causing leakage and odor, and lack of water and safe hygiene facilities. Menstrual cups designed for use during sex may help women prevent Bacterial vaginosis (BV) and STIs through hygienic period practices, and may help them avoid bad practices in an attempt to maintain vaginal dryness. The goal of this interventional trial is to test the impact of menstrual cups on vaginal microbiome, BV, and STIs of poor women at high risk for STIs and HIV. We predict to see 25% less BV, our primary outcome, over one year. This trial aims to learn more about the safety of the intervention, and understand what is needed to fully implement the program.

NCT ID: NCT05630859 Active, not recruiting - Clinical trials for 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.

Start date: November 28, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this first time in human proof of concept (FTiH-PoC) study is to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized modules for membrane antigens (GMMA) (NgG) investigational vaccine compared to placebo (saline).