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Gonorrhea clinical trials

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NCT ID: NCT06090565 Completed - Gonorrhea Clinical Trials

Cefixime Plus Doxycycline Compared to Ceftriaxone Plus Azithromycin for Treatment of Gonorrhoea

Start date: April 1, 2021
Phase: Phase 4
Study type: Interventional

A non-inferiority, open-label, multicentre randomised controlled trial to compare two therapeutic regimens for the treatment of uncomplicated urogenital, rectal or pharyngeal gonorrhoea in men and women between 18 and 75 years of age. Patients were enrolled and treated from April 2021 to June 2022 at the Dermatovenerology Department, University Hospital Bulovka, Prague, Czech Republic and the Venereology Prague, Medicentrum Beroun, Prague, Czech Republic.

NCT ID: NCT05613725 Completed - Gonorrhea Clinical Trials

OptiGon - Optimising Laboratory Assays for Immune Responses to Gonococcus

Start date: December 2, 2022
Phase:
Study type: Observational

This is an observational study. Blood from otherwise healthy patients presenting with confirmed N.gonorrhoea infection, prior to treatment, will be collected to (i) allow the optimisation of assays assessing the immune response to gonococcus and (ii) assess whether N. gonorrhea specific responses can be detected on ELIspot +/- flow cytometry. The investigators plan to recruit up to 30 adults (men and women, aged 18-50 years) who have been diagnosed with confirmed N.gonorrhoea infection at the Sexual Health Clinic at the Oxford University Hospitals NHS Foundation Trust. The investigators will collect blood samples from consenting participants prior to them receiving curative antibiotic treatment.

NCT ID: NCT05391035 Completed - Clinical trials for Antibiotic Resistant Infection

The Antibiotic Guardian Study- Clinical Evaluation of a Novel, Rapid Diagnostic for Gonorrhoea and Mycoplasma Infections.

Guardian
Start date: October 1, 2019
Phase:
Study type: Observational

Primary research question: Are novel molecular tests for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance sensitive and specific in symptomatic patients attending a sexual health clinic? Secondary research question: Are novel molecular tests for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques?

NCT ID: NCT05307991 Completed - HIV Infections Clinical Trials

Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe

Start date: March 9, 2022
Phase:
Study type: Observational

This is a prospective cohort study evaluating acceptability, feasibility, and effectiveness of integrating HIV pre-exposure prophylaxis (PrEP) into a sexually transmitted infection (STI) clinic alongside assisted partner notification and etiologic STI testing in Lilongwe, Malawi.

NCT ID: NCT05216744 Completed - Clinical trials for Chlamydia Trachomatis Infection

Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection

Start date: July 15, 2021
Phase: Phase 2
Study type: Interventional

The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates.Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.

NCT ID: NCT05027516 Completed - Clinical trials for Neisseria Gonorrhoeae

Trial Comparing Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Gonorrhea

ResistAZM
Start date: January 17, 2022
Phase: Phase 4
Study type: Interventional

In this Randomized Controlled Trial, the investigators will recruit 42 men attending the STI and HIV clinic at the Institute of Tropical Medicine, with a diagnosis of N. gonorrhoeae and randomize them 1:1 to receive either ceftriaxone or ceftriaxone/azithromycin. They will be followed-up for a test of cure visit at day 14 post-treatment where urine, oropharyngeal and anorectal samples will be taken to test for cure and monitor treatment effects on the microbiome and resistome. The primary outcome will be evaluating the difference in the abundance of resistance conferring genes in the rectal microbiome in the two arms, 14 days after the receipt of therapy.

NCT ID: NCT04955717 Completed - Preterm Birth Clinical Trials

Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences

Start date: February 24, 2021
Phase: N/A
Study type: Interventional

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 symptoms and signs).

NCT ID: NCT04902560 Completed - Gonorrhea Clinical Trials

Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study

GONOCEF
Start date: May 1, 2021
Phase:
Study type: Observational

Sexual health centers (CeGIDD, in France) manage the majority of STI in France, especially gonorrhea. Patients wanting STI screening can consult either they are symptomatic or not. If they are symptomatic, they can be treated immediately. If they are not symptomatic, they must come back seven days after in order to get their results and to be treated if necessary. Before any treatment for gonorrhea, subjects should be sampled for bacterial culture in order to perform AMR surveillance. After every treatment for gonorrhea, subjects should realized a test of cure (TOC) according to current recommandation. Response rate to ceftriaxone 1g IM for treating gonorrhea has never been evaluated in France while being used widely over the past months. Compliance to current recommandation at CeGIDD Montpellier has never been evaluated. This study will assess the response rate to ceftriaxone 1g IM as gonorrhea treatment by realizing a test of cure 14 days after each treatment.

NCT ID: NCT04870138 Completed - Clinical trials for Gonococcal Infection

Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

Start date: March 10, 2013
Phase: Phase 1
Study type: Interventional

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. The study is designed to test the requirements of predicted N. gonorrhoeae virulence determinants for gonococcal infection in the male urethra through infection with engineered mutants of N. gonorrhoeae. We predict that mutations abolishing expression of N. gonorrhoeae virulence determinants will eliminate or significantly reduce gonococcal infectivity or the ability to induce inflammation in an infected individual, thus identifying potential vaccine candidates. Study duration will be 1 year, and the duration for all participants will be about 3 weeks. The primary objective of the study is to compare the ability of different engineered mutants of Neisseria gonorrhoeae to cause a clinical infection (signs or symptoms of urethritis such as discomfort during urination, urethral discharge, etc.) in the male urethra.

NCT ID: NCT04722003 Completed - Gonorrhoea Clinical Trials

Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination

Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

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, using a placebo vaccine (normal saline) as a comparator (group 2, 10 subjects). There will be approximately 50 participants, ages 18-49, both male and non-pregnant female subjects, enrolled at 1 site in the US. The goal will be to ensure adequate representation of subjects by sex in both treatment groups. The enrollment will be stratified by both sex and treatment arm. During enrollment of the "biopsy cohort" male and non-pregnant female subjects will be randomized 4:1 to either 4CMenB or placebo, up to a maximum of 10 male and 10 non-pregnant female subjects. Group 1 (approximate N=40) will receive two doses of 4CMenB on Day 1 and Day 29. Group 2 (approximate N=10) will receive two placebo injections on Day 1 and Day 29. Both groups will receive a single-dose prefilled syringe that is administered intramuscularly (0.5-mililiter each). The duration of each subject's participation is approximately 8 months, from recruitment through the last study visit, and the length of the study is estimated for 14 months. The primary objective is to characterize the rectal mucosal Immunoglobulin G IgG antibody response to Neisseria gonorrhoeae (GC) elicited by the 4CMenB vaccine as compared with the placebo vaccine (normal saline) in healthy adult subjects.