Treatment for Gonorrhea

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
GSK Investigational Site, Frankfurt, Germany
Gonorrhea
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether an oral medication is as effective as an injection for treating gonorrhea.

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Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 18 secondary outcomes in patients with Gonorrhea. Measurement will happen over the course of Baseline and up to Day 8.

Day 8
Change from Baseline in albumin and total protein levels
Change from Baseline in aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels
Change from Baseline in blood urea nitrogen, glucose non-fasting, calcium, chloride, sodium and potassium levels
Change from Baseline in body temperature
Change from Baseline in hematocrit level
Change from Baseline in hemoglobin level
Change from Baseline in mean corpuscular hemoglobin (MCH)
Change from Baseline in mean corpuscular volume (MCV)
Change from Baseline in neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count
Change from Baseline in pulse rate
Change from Baseline in red blood cell (RBC) count
Change from Baseline in specific gravity of urine
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Change from Baseline in total bilirubin, direct bilirubin and creatinine levels
Up to Day 21
Number of subjects with treatment-emergent adverse events and serious adverse events (SAEs)
Up to Day 8
Number of subjects with abnormal urinalysis Dipstick results
Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the pharyngeal site at the TOC
Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the rectal site at the TOC
Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site at the Test-of-Cure (TOC)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Gepotidacin
1 of 2
Ceftriaxone plus Azithromycin
1 of 2
Active Control

This trial requires 600 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Gepotidacin
Drug
Subjects will receive Gepotidacin orally at the study site during the Baseline (Day 1) visit followed by self-administration of a second oral dose as an outpatient 10 to 12 hours after the first dose.
Ceftriaxone plus AzithromycinSubjects will receive a single IM dose of Ceftriaxone plus a single oral dose of Azithromycin at the study site during the Baseline (Day 1) visit.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 21
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to day 21 for reporting.

Closest Location

GSK Investigational Site - Honolulu, HI

Eligibility Criteria

This trial is for patients born any sex of any age. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects with body weight >45 kg. show original
Subjects must be >=12 years of age at the time of signing the informed consent.
Male or female subjects having his or her original urogenital anatomy at birth.
Male subject must agree to use contraception (male condoms) during intercourse from the Baseline Visit through completion of the TOC Visit.
Female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance (male partners of WOCBP must use a male condom during intercourse) from the Baseline Visit through completion of the TOC Visit.
Subjects who are capable of giving informed consent or assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) or assent form and in study protocol. show original
Subjects with clinical suspicion of a urogenital gonococcal infection with or without pharyngeal and/or rectal gonococcal infection and have one of the following: male subjects with purulent yellow, green, or white urethral discharge or female subjects with abnormal cervical or vaginal mucopurulent discharge upon physical examination; or a prior positive culture for N. show original
Subjects who are willing to avoid anal, oral, and vaginal sexual intercourse or use condoms for all forms of intercourse from the Baseline Visit through the TOC Visit. show original

Patient Q&A Section

What are the signs of gonorrhea?

"Signs of gonorrhea involve vaginal discharge with dysuria and/or painful urination. Signs of urethral gonorrhea in men include painful urination along with a discharge from the penis that is green, white, yellow or greyish-yellow. In men who have sex with men, symptoms of chlamydia often mimic those of gonorrhea infections. Signs of other sexually transmitted infections (STIs) that can affect the genitals include painful urination, itching and swollen or red genitals are also characteristic of gonorrhea. In many cases there will be concurrent signs of STI." - Anonymous Online Contributor

Unverified Answer

What are common treatments for gonorrhea?

"Gonorrhea is no longer a "sexually transmitted" disease and is instead treated with antibiotics. Common treatments include oral antibiotics, i.v. antibiotics in a sterile site (usually the thigh), IV antibiotics and, in the case of men who are unable to get an erection for one reason or another, penis packing. Patients may also choose to use condoms after receiving counseling and education on the disease and its transmission." - Anonymous Online Contributor

Unverified Answer

What is gonorrhea?

"Gonorrhea is an infection of the Ureaplasma urealyticum subgroup. Approximately half of the men infected with gonorrhea are asymptomatic. The risk factors for gonorrhea infection are younger age and having multiple partners. In men with no asymptomatic gonorrhea infection, screening is not currently recommended, although asymptomatic gonorrhea can be contracted by sexual contact. The risk of genital gonorrhea in females is greater (60%) than previously reported (30%)." - Anonymous Online Contributor

Unverified Answer

Can gonorrhea be cured?

"Currently, there is no evidence of a cure for gonorrhea. However, the gonorhea bacterium can be very effectively cured by antibacterial treatment; thus, antibiotics appear to be the most important factor in management of gonorrhea. There is also evidence that antibiotics can greatly diminish the time needed to get gonorrhea in a treated individual back to normal." - Anonymous Online Contributor

Unverified Answer

What causes gonorrhea?

"Gonorrhea is caused by the bacteria Chlamydia trachomatis. It is transmitted sexually when a person has an abnormal and painful sex arousal (e.g. if the penis is swollen or sore) or by sexual exposure to saliva, tears, or vomit. The person will not get untreated and may be passed on to others. The signs and symptoms of gonorrhea include vaginal discharge (not a vaginal odor), burning sensation during or after sex, and painful sexual intercourse. In males, the symptoms include lower abdominal or back pain, soreness in the scrotum, and swelling. Symptoms can last for weeks." - Anonymous Online Contributor

Unverified Answer

How many people get gonorrhea a year in the United States?

"About 13 million cases [were experienced monthly (6.7 cases/100,000 population), of whom 89% were symptomatic (12.4 cases/100,000 population)] and 1.2 million cases occurred annually in 2009. Cases [of symptomal meningitis (1.1 cases/100,000 population), in children aged 14 years or younger (0.7 cases/100,000) and in pregnant women (4.9 cases/100,000)] were uncommon. Cases [of prostatitis (0.8 cases/100,000 population) and of pneumonia (15.9 cases/100,000 population)] were uncommon." - Anonymous Online Contributor

Unverified Answer

How serious can gonorrhea be?

"The proportion of women and men with an infection, gonorrhea was 5% and 15% respectively (P<0.05). Most men were discharged from the study because it complied with a request from their general practitioner to discontinue follow-up and were not interviewed for this study." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"The use of single drug treatment is the main method. In addition, most of patients use several drugs to be treated with. Even though the prevalence of bacterial vaginosis is high and only few patients are treated for bacterial vaginosis alone, the rate of bacterial vaginosis treatment has a decreasing trend of 20% over 10 years. Moreover, it is advisable that in the future, it is also necessary to educate patients about bacterial vaginosis and treat bacterial vaginosis so that they would understand what triggers abnormal body states." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets gonorrhea?

"Men who have sex with men have a 4- to 6-fold higher chance of acquiring gonorrhea than women. Prevention of infections should therefore target both men and women." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of gonorrhea?

"Gonorrhea infection continues to be primarily transmitted to males via multiple routes. Males and females often play different roles in the sexual contact chains of infection, suggesting that sexual behavior are often the key factor that causes gonorrhea infections." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving treatment?

"There have been no other clinical trials investigating new therapies for gonorrhea. There is much interest in research in this field to determine the best treatment for gonorrhea. Clinical trials on this topic are therefore needed. [Power(https://www.accessdata.fda.gov/datashow/ctb/clinicaltrials.htm)] [Power(http://www.withpower.com/clinical-trials/clinical-trial-pages) permits you to research clinical trials. These trials tailor to your condition, treatment, and location." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"This trial is enrolling patients at risk for long-term treatment-related side effects using the current standard of care for gonorrhea patients. Although the frequency of some side effects is higher in participants than the general population, the severity and potential burden of these effects are not clear. Clinical trials help to gauge the risks of side effects and how to monitor for them through the use of outcome measures. If you want to join a gonorrhea clinical trial, you can power to find recent trials by condition, treatment, or location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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