Gepotidacin for Urinary Tract Infections

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
GSK Investigational Site, Poprad, Slovakia
Urinary Tract Infections+2 More
Gepotidacin - Drug
Eligibility
Any Age
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat urinary tract infections.

See full description

Eligible Conditions

  • Urinary Tract Infections

Treatment Effectiveness

Effectiveness Estimate

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

Compared to trials

Study Objectives

This trial is evaluating whether Gepotidacin will improve 2 primary outcomes and 49 secondary outcomes in patients with Urinary Tract Infections. Measurement will happen over the course of Day 1.

Day 13
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 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 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
Day 10
Change from Baseline in body temperature
Change from Baseline in clinical chemistry parameters: Albumin and total protein levels (Gram per Liter)
Change from Baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels (International units per Liter)
Change from Baseline in clinical chemistry parameters: Blood urea nitrogen (BUN), glucose non-fasting, calcium, chloride, sodium, magnesium, phosphorus and potassium levels (Millimoles per Liter)
Change from Baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter)
Change from Baseline in hematology parameter: Mean corpuscular hemoglobin (MCH)
Change from Baseline in hematology parameter: Mean corpuscular volume (MCV)
Change from Baseline in hematology parameter: Red blood cell (RBC) count
Change from Baseline in hematology parameter: hematocrit level
Change from Baseline in hematology parameter: hemoglobin level
Change from Baseline in hematology parameters: neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count (Giga cells per Liter)
Change from Baseline in pulse rate
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg])
Day 1
Peak concentration of gepotidacin in plasma
Peak concentration of gepotidacin in urine
Days 10 to 13
Number of participants with abnormal urinalysis Dipstick results
Number of participants with clinical outcome and response at the TOC visit
Number of participants with per participant microbiological outcome and response at the TOC visit
Number of participants with therapeutic response (combined per participant clinical and microbiological response) at the Test-of-Cure (TOC) visit
Days 25 to 31
Number of participants with clinical outcome and response at the follow-up visit
Number of participants with per participant microbiological outcome and response at the follow-up visit
Number of participants with therapeutic response (combined per participant clinical and microbiological response) at the follow-up visit
Up to Day 13
Number of subjects with abnormal urinalysis Dipstick results
Number of subjects with clinical response at the TOC visit
Number of subjects with indicated clinical outcome at the TOC visit
Number of subjects with indicated microbiological outcome at the TOC visit
Number of subjects with microbiological response at the TOC visit
Number of subjects with therapeutic response at Test-of-Cure (TOC) visit
Up to Day 3
Trough concentration of gepotidacin in plasma
Trough concentration of gepotidacin in urine
Up to Day 31
Number of participants with Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Number of subjects with Treatment-emergent adverse events and serious adverse events (SAEs)
Number of subjects with clinical response at the follow-up visits
Number of subjects with indicated clinical outcome at the follow-up visits
Number of subjects with indicated microbiological outcome at the follow-up visits
Number of subjects with microbiological response at the follow-up visits
Number of subjects with therapeutic response at follow-up visits
Up to Day 5
Plasma concentration of gepotidacin
Urine concentration of gepotidacin

Trial Safety

Safety Estimate

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

Compared to trials

Trial Design

2 Treatment Groups

Nitrofurantoin
1 of 2
Gepotidacin
1 of 2
Active Control
Experimental Treatment

This trial requires 2500 total participants across 2 different treatment groups

This trial involves 2 different treatments. Gepotidacin is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

GepotidacinParticipants will be administered oral doses of 1500 milligrams (mg) gepotidacin plus nitrofurantoin matching placebo twice daily (BID); approximately every 12 hours for 5 days
NitrofurantoinParticipants will be administered oral doses of 100 mg nitrofurantoin plus gepotidacin matching placebo BID; approximately every 12 hours for 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gepotidacin
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, on-therapy (days 2 to 4), and test of cure (days 10 to 13)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, on-therapy (days 2 to 4), and test of cure (days 10 to 13) for reporting.

Closest Location

GSK Investigational Site - Memphis, TN

Eligibility Criteria

This trial is for female patients of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants having >=12 years of age at the time of signing the informed consent/assent and have a body weight >=40 kilograms (kg).
Participants having 2 or more of the following clinical signs and symptoms of acute cystitis with onset <96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain.
Participants having nitrite or pyuria (greater than [>]15 white blood cells [WBC]/high power field [HPF] or the presence of 3 plus [+]/large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures.
The participant is female.
Participant is capable of giving signed informed consent/assent.

Patient Q&A Section

What are common treatments for urinary tract infections?

"Antibiotics such as ciprofloxacin and piperacillin tazobactam are widely used and are effective to prevent infection with uropathogenic E. coli. Ketorolac is sometimes used in the treatment of pain or fever, but it is ineffective and associated with an increased risk of resistance. The use of alternative medications such as diclofenac should, thus far, be restricted to those whose pain is severe. Antibiotics also may be used in the treatment of recurrent urinary tract infections, in this case ciprofloxacin or piperacillin-tazobactam may be prescribed." - Anonymous Online Contributor

Unverified Answer

How many people get urinary tract infections a year in the United States?

"Urologists, in addition to considering demographics, make clinical history, and clinical findings, should add the results of a urinalysis to the differential diagnosis of UTI. On average, the estimated yearly incidence of UTI in women in the United States is 4.5 cases per 100 persons per year." - Anonymous Online Contributor

Unverified Answer

What is urinary tract infections?

"Urinary tract infections are an important complaint among patients and physicians. Patients often do not present to the outpatient clinic in time for diagnostic imaging or in time to get appropriate antibiotic treatment. Urinary tract infection is an important clinical problem in the outpatient setting." - Anonymous Online Contributor

Unverified Answer

What are the signs of urinary tract infections?

"Women with urinary tract infections may complain of pain with urination, frequency, burning sensation, feeling that there is something in the urine and/or painful urinating during orgasm. All signs of a urinary tract infection are also present in men. Men may also complain of pain with urination, passing urine outside of the bladder and feeling that some parts of the bladder feel swollen. All signs of a urinary tract infection are also present in women. In both sexes, the urine may look cloudy, have a distinct smell or smell sour. The urine may also contain blood or white urine in some cases." - Anonymous Online Contributor

Unverified Answer

Can urinary tract infections be cured?

"Bacterial UTIs are common but usually disappear after antibiotics alone. Urinary calculi in women are strongly associated with UTIs, which can be adequately treated with a 2 times daily dosing of antibiotics for 7 days." - Anonymous Online Contributor

Unverified Answer

What causes urinary tract infections?

"UTIs occur whenever bacteria enter the lower urinary tract. They are caused by bacteria entering the body by urination, by sexual activity, or by an injury to the urinary tract. Women typically have more than one type of infection in this way. They often have mixed infections, caused by two or more bacterial species. When organisms can be identified by culture, appropriate antibiotics can be used, although there are no cures. The number of cases will remain high in countries which lack good sanitation and reliable information. The problem arises because many cultures and methods of detection are inadequate to identify most causes, but the use of simple samples and rapid test results has reduced it considerably." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with urinary tract infections?

"Overall, in this pilot study, there was no clear evidence linking a 6-week antibiotic treatment course with improvements in generic health status or mood. However, when specific aspects and dimensions of quality of life were examined, there were improvements in some aspects, such as bodily/sensation (general health score) and feelings about the impact on quality of life (mood and emotions)." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"The most frequent treatment for recurrent urinary tract infection (UTI) is the use of antibiotics. There are multiple treatments available and each method has its own benefits and risks. The choice of the treatment depends not only on the efficacy but also on the benefits (i.e. side-effect of the chosen treatment) it is associated with. It is possible that the best option varies by type of infection: urinary tract infection; recurrent pelvic cellulitis; complicated cystitis and pyelonephritis; prostatitis in men; pelvic inflammatory disease in women; pelvic inflammatory cystitis and peri-operative wound infection." - Anonymous Online Contributor

Unverified Answer

Does urinary tract infections run in families?

"It is concluded that UTIs run in families. Most of the families harboring UTIs are symptomatic.UTIs run in families from an early age and those families with multiple UTI generations would require a close observation of the UTI's occurrence for the detection of familial predisposition." - Anonymous Online Contributor

Unverified Answer

Is treatment safe for people?

"Symptoms are common with antibiotics. The proportion of patients who develop symptoms is similar in recipients of antibiotics and patients who did not receive antibiotics for urinary tract infection. Receipt of antibiotics should not be withheld or withheld for the sole concern that symptoms may develop." - Anonymous Online Contributor

Unverified Answer

How serious can urinary tract infections be?

"UTI affects more than 60% of the population at some point in life and is the most common cause of urinary tract infection and urinary tract hospitalisation. Complications such as urolithiasis and pyelonephritis can complicate the condition." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating urinary tract infections?

"There are no new compounds or new mechanism of action to treat UTIs. However, there may be a better way to use existing medicines and more research may be discovered. One way to obtain more UTI treatment research would be with randomized control trials. However, we also found that it is difficult to get funding for such trials as most pharmaceutical companies do not want to invest in research aimed squarely at a disease with less commercially viable benefits. Although there has not been any drug developed specifically to treat UTIs, there are still many strategies that can be utilized to make existing drugs more useful, such as: making the dosage stronger, more effective, and/or increasing the duration of the treatment." - 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.
See if you qualify for this trial
Get access to this novel treatment for Urinary Tract Infections by sharing your contact details with the study coordinator.