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Gonorrhea clinical trials

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NCT ID: NCT02870101 Completed - Clinical trials for Sexually Transmitted Infections

Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT

pNAAT
Start date: April 10, 2017
Phase: N/A
Study type: Interventional

The purpose of this study was to use participant samples to simultaneously evaluate three nucleic acid amplification tests (NAATs) diagnostic platforms.

NCT ID: NCT02708992 Completed - Gonorrhoea Clinical Trials

Cefixime / Azithromycin pK Study

Start date: April 28, 2016
Phase: Phase 1
Study type: Interventional

This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and whether there are significant changes in cefixime PK after co-administration. The primary pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin, achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen of 800

NCT ID: NCT02513225 Completed - Drug Use Clinical Trials

Trial of an Adapted STD Screening and Risk Reduction Intervention

Start date: July 2015
Phase: N/A
Study type: Interventional

The goal of this research study is to evaluate the impact of a paraprofessional-delivered, culturally adapted, evidence-based intervention (EBI) on sexually transmitted disease (STD), substance use and poor mental/emotional health among American Indians (AI) through a Randomized Controlled Trial (RCT). These intertwining risks have produced marked disparities and have unique cultural and social determinants in Native communities. If aims are achieved, scientific knowledge and community-based practice will be advanced in areas vital to AI communities, and to STD and drug prevention science. Prior to this study, the investigators applied findings from research protocol (IRB#00005929) and adapted a brief intervention to reduce risk and increase protective behaviors for STDs, HIV/AIDS, substance use and poor mental/emotional health, and to promote STD screening. The specific aim of the current study is to compare the efficacy of the adapted brief intervention vs. a comparison condition on participants' condom use, STD screening and treatment-seeking behaviors, substance use and emotional/mental health outcomes at 3 and 6 months post-intervention.

NCT ID: NCT02447484 Completed - HIV Clinical Trials

Texting Intervention to Sustain HIV Prevention in Women in High-drug-use Contexts

Start date: July 1, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a program of regular, theory-based text messages that encourages the message recipient to continue practicing safer sex (i.e., using condoms with sex partners) is effective in maintaining positive behavior change in women who have completed a brief safer-sex training.

NCT ID: NCT02391233 Completed - HIV Clinical Trials

Multimedia WORTH With Black Drug-Involved Women on Probation

E-WORTH
Start date: November 15, 2015
Phase: N/A
Study type: Interventional

The proposed study is a randomized controlled trial (RCT) that will rigorously evaluate the effectiveness and cost-effectiveness of delivering a multimedia evidence-based intervention (WORTH) and streamlined HIV testing to prevent human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) with Black/African-American (hereafter referred to as Black) women drug users in probation sites in New York City (NYC), compared to streamlined HIV testing alone. Repeated assessments will occur at baseline and 3, 6, and 12-months post intervention. The primary outcomes will be to reduce cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas and the number of unprotected sex acts.

NCT ID: NCT02350907 Completed - Gonorrhoea Clinical Trials

Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea

RaDAR-Go
Start date: February 2015
Phase:
Study type: Observational

The purpose of this study is to develop a laboratory-based assay that will be a real-time PCR test to detect the organism N. gonorrhoeae and its most important genetic markers of antimicrobial resistance. This study will also determine factors associated with gonorrhoea and describe sexual behaviours of men who have sex with men, to inform parameters for a mathematical model of gonorrhoea transmission and antimicrobial resistant gonorrhoea.

NCT ID: NCT02348424 Completed - Gonorrhoea Clinical Trials

Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

Start date: May 5, 2015
Phase: Phase 1
Study type: Interventional

This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal pharmacokinetics of a single 1000mg oral dose of solithromycin. Study Objectives: The primary objective is to determine the pharmacokinetics of solithromycin in plasma, vaginal, cervical, seminal, rectal, and pharyngeal fluid samples after a single 1000mg oral dose.

NCT ID: NCT02294682 Completed - Gonorrhea Clinical Trials

A Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae

Start date: April 2015
Phase: Phase 2
Study type: Interventional

GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized, multicenter, open-label, dose ranging study designed to inform the optimal oral dose of GSK2140944 by further characterizing the efficacy, safety, and tolerability in subjects with uncomplicated urogenital gonorrhea due to N. gonorrhoeae. Subjects will be randomly assigned to receive either a single 1500 milligrams (mg) or 3000 mg oral dose of GSK2140944. Appropriate safety and microbiological assessments will be conducted at the Baseline (Day 1) Visit and repeated at the Test-of-Cure (Day 4 to 8) Visit. The study duration will be approximately 1 week. Approximately 60 microbiologically evaluable subjects (30 subjects in each treatment arm) will complete the study if both arms remain active throughout the study.

NCT ID: NCT02257918 Completed - Gonorrhoea Clinical Trials

Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea

Start date: November 2014
Phase: Phase 2
Study type: Interventional

This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male and female subjects, between the ages of 18 and 55, who are in good health and meet all eligibility criteria. The study is designed to assess the safety and efficacy of an antimicrobial investigational product, AZD0914 manufactured by AstraZeneca, administered to adults to treat uncomplicated urogenital gonorrhea compared to treatment with ceftriaxone. Subjects will be randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of AZD0914, 3000 mg of AZD0914, or intramuscular dose of 500 mg of ceftriaxone. The drug name is also known as ETX0914.

NCT ID: NCT02210325 Completed - Clinical trials for Uncomplicated Urogenital Gonorrhea

Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea

SOLITAIRE-U
Start date: August 2014
Phase: Phase 3
Study type: Interventional

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. A completed open-label Phase 2 study with single doses of solithromycin resulted in 100% microbiological eradication in male and female patients with uncomplicated urogenital gonorrhea.