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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05630833




Registration number
NCT05630833
Ethics application status
Date submitted
23/11/2022
Date registered
30/11/2022

Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
Scientific title
A Phase III, Multicenter, Randomized, Active Reference, Double Blind, Double-dummy Study in Japanese Female Participants to Evaluate the Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
Secondary ID [1] 0 0
214144
Universal Trial Number (UTN)
Trial acronym
EAGLE-J
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Tract Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gepotidacin
Treatment: Drugs - Nitrofurantoin
Treatment: Drugs - Placebo

Experimental: Gepotidacin + Placebo -

Active comparator: Nitrofurantoin + Placebo -


Treatment: Drugs: Gepotidacin
Gepotidacin will be administered.

Treatment: Drugs: Nitrofurantoin
Nitrofurantoin will be administered.

Treatment: Drugs: Placebo
Placebo will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit
Timepoint [1] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [1] 0 0
Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population
Timepoint [1] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [2] 0 0
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Timepoint [2] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [3] 0 0
Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population
Timepoint [3] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [4] 0 0
Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population
Timepoint [4] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [5] 0 0
Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population
Timepoint [5] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [6] 0 0
Number of Participants With Therapeutic Response (TR) at the TOC Visit
Timepoint [6] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [7] 0 0
Number of Participants With Clinical Outcome at the TOC Visit
Timepoint [7] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [8] 0 0
Number of Participants With Clinical Response at the TOC Visit
Timepoint [8] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [9] 0 0
Number of Participants With Microbiological Outcome at the TOC Visit
Timepoint [9] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [10] 0 0
Number of Participants With Microbiological Response at the TOC Visit
Timepoint [10] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [11] 0 0
Number of Participants With Investigator Assessed Clinical Response
Timepoint [11] 0 0
At TOC visit (Days 9 to 16)
Secondary outcome [12] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [12] 0 0
From first dose (Day 1) to Follow-up visit (Days 21 to 31)
Secondary outcome [13] 0 0
Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs)
Timepoint [13] 0 0
From first dose (Day 1) to Follow-up visit (Days 21 to 31)
Secondary outcome [14] 0 0
Number of Participants With Urinalysis Dipstick Results
Timepoint [14] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [15] 0 0
Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate
Timepoint [15] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [16] 0 0
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF
Timepoint [16] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [17] 0 0
Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Timepoint [17] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [18] 0 0
Change From Baseline (CFB) in Vital Sign: Temperature
Timepoint [18] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [19] 0 0
Change From Baseline (CFB) in Vital Sign: Pulse Rate
Timepoint [19] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [20] 0 0
Plasma Concentrations of Gepotidacin
Timepoint [20] 0 0
Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose
Secondary outcome [21] 0 0
Urine Concentrations of Gepotidacin
Timepoint [21] 0 0
Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose
Secondary outcome [22] 0 0
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit
Timepoint [22] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [23] 0 0
Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit
Timepoint [23] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [24] 0 0
Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit
Timepoint [24] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [25] 0 0
Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit
Timepoint [25] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [26] 0 0
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit
Timepoint [26] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [27] 0 0
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit
Timepoint [27] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [28] 0 0
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit
Timepoint [28] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [29] 0 0
Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit
Timepoint [29] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [30] 0 0
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Timepoint [30] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [31] 0 0
Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit
Timepoint [31] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [32] 0 0
Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit
Timepoint [32] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [33] 0 0
Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit
Timepoint [33] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Secondary outcome [34] 0 0
Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit
Timepoint [34] 0 0
Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)

Eligibility
Key inclusion criteria
* The participant has a body weight >=40 kilograms (kg).
* The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset less than (<) 96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain.
* The participant has nitrite or pyuria (greater than [>]15 white blood cell [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 capable of giving signed informed consent/assent.
Minimum age
12 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* The participant resides in a nursing home or dependent care type facility.
* The participant has a body mass index >=40.0 kilogram per meter square (kg/m^2) or a body mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditions such as uncontrolled high blood pressure or uncontrolled diabetes.
* The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications.
* The participant has any of the following:

* Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain; Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; a history of seizure disorder requiring medications for control (this does not include a history of childhood febrile seizures); Or
* Known acute porphyria.
* Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention.
* The participant has a known glucose-6-phosphate dehydrogenase deficiency.
* The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
* The participant has acute uncomplicated cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacterales (other than E. coli) as the contributing pathogen.
* The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments or preclude complete resolution of acute cystitis symptoms.
* The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesicoureteral reflux, detrusor insufficiency).
* The participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract.
* The participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptom onset >=96 hours before study entry, or a temperature >=38 Degrees Celsius [°C], flank pain, chills, or any other manifestations suggestive of upper UTI.
* The participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance <60 milliliters per minute (mL/min) or clinically significant elevated serum creatinine as determined by the investigator).
* The participant presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease).
* The participant has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval.
* The participant has uncompensated heart failure.
* The participant has severe left ventricular hypertrophy.
* The participant has a family history of QT prolongation or sudden death.
* The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months.
* The participant is taking QT-prolonging drugs or drugs known to increase the risk of torsades de pointes (TdP) per the www.crediblemeds.org. "Known Risk of TdP" category at the time of her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor.
* For any participant >=12 to <18 years of age, the participant has an abnormal ECG reading at Baseline.
* The participant has a QTc >450 msec or a QTc >480 msec for participants with bundle branch block.
* The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months.
* The participant has a known alanine aminotransferase (ALT) value >2 times upper limit of normal (ULN).
* The participant has a known total bilirubin value >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
* The participant has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice.
* The participant has a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin.
* The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/02/2024
Sample size
Target
Accrual to date
Final
380
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Chiba
Country [2] 0 0
Japan
State/province [2] 0 0
Fukuoka
Country [3] 0 0
Japan
State/province [3] 0 0
Gunma
Country [4] 0 0
Japan
State/province [4] 0 0
Hokkaido
Country [5] 0 0
Japan
State/province [5] 0 0
Ibaraki
Country [6] 0 0
Japan
State/province [6] 0 0
Kagoshima
Country [7] 0 0
Japan
State/province [7] 0 0
Kanagawa
Country [8] 0 0
Japan
State/province [8] 0 0
Kochi
Country [9] 0 0
Japan
State/province [9] 0 0
Miyagi
Country [10] 0 0
Japan
State/province [10] 0 0
Osaka
Country [11] 0 0
Japan
State/province [11] 0 0
Saga
Country [12] 0 0
Japan
State/province [12] 0 0
Saitama
Country [13] 0 0
Japan
State/province [13] 0 0
Tokyo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05630833