Phase 3
N=380
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
Urinary Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT05630833 ↗Enrolled (actual)
380
Serious AEs
0.5%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit — 69; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gepotidacin (Drug); Nitrofurantoin (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit |
69; 14 | — |
| SECONDARY Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population |
69; 17; 14; 8 | — |
| SECONDARY Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population |
71; 19; 5; 4; 3; 2 | — |
| SECONDARY Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population |
71; 19; 12; 6 | — |
| SECONDARY Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population |
74; 20; 0; 0; 1; 3 | — |
| SECONDARY Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population |
74; 20; 9; 5 | — |
| SECONDARY Number of Participants With Therapeutic Response (TR) at the TOC Visit |
14; 2; 4; 1 | — |
| SECONDARY Number of Participants With Clinical Outcome at the TOC Visit |
14; 2; 2; 0; 1; 1 | — |
| SECONDARY Number of Participants With Clinical Response at the TOC Visit |
14; 2; 4; 1 | — |
| SECONDARY Number of Participants With Microbiological Outcome at the TOC Visit |
16; 2; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Microbiological Response at the TOC Visit |
16; 2; 2; 1 | — |
| SECONDARY Number of Participants With Investigator Assessed Clinical Response |
242; 86; 28; 6; 11; 1 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
201; 18 | — |
| SECONDARY Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs) |
2; 0; 191; 12 | — |
| SECONDARY Number of Participants With Urinalysis Dipstick Results |
3; 1; 4; 5; 273; 87 | — |
| SECONDARY Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate |
67.2; 70.7; -0.5; -3.3; 0.5; -1.6 | — |
| SECONDARY Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF |
154.9; 159.3; 1.6; 1.4; 0.3; 0.6 | — |
| SECONDARY Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) |
72.8; 74.5; -2.6; -2.1; -2.4; -3.9 | — |
| SECONDARY Change From Baseline (CFB) in Vital Sign: Temperature |
36.49; 36.44; -0.05; -0.03; -0.07; -0.02 | — |
| SECONDARY Change From Baseline (CFB) in Vital Sign: Pulse Rate |
69.7; 72.2; 2.4; 1.4; 0.4; -0.5 | — |
| SECONDARY Plasma Concentrations of Gepotidacin |
5210.23; 5251.54; 1960.14; 17548.67; 5976.40 | — |
| SECONDARY Urine Concentrations of Gepotidacin |
506.988; 600.729; 492.096; 901.554; 1138.900 | — |
| SECONDARY Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit |
0.050; 0.051; -0.004; -0.001; -0.001; -0.002 | — |
| SECONDARY Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit |
128.6; 128.0; -1.3; -1.0; -2.3; -2.9 | — |
| SECONDARY Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit |
0.4355; 0.4308; -0.0047; 0.0067; -0.0082; -0.0038 | — |
| SECONDARY Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit |
4.302; 4.245; -0.040; -0.025; -0.085; -0.098 | — |
| SECONDARY Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit |
29.97; 30.26; -0.03; -0.05; 0.04; 0.00 | — |
| SECONDARY Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit |
101.48; 101.65; -0.16; 2.40; 0.08; 1.61 | — |
| SECONDARY 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 |
2.319018; 2.314716; -0.004536; -0.012341; -0.032315; -0.029885 | — |
| SECONDARY Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit |
102.3; 102.4; 0.8; 0.3; 1.0; 0.6 | — |
| SECONDARY Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit |
3.4498; 3.4329; -0.0056; -0.0129; -0.0063; -0.0113 | — |
| SECONDARY Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit |
1.8346749; 1.8690338; -0.1155781; 0.0331548; -0.0284139; -0.0111724 | — |
| SECONDARY Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit |
44.7; 44.1; -0.4; -0.3; -1.3; -1.2 | — |
| SECONDARY Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit |
68.9; 68.4; -0.1; -0.4; -2.9; -3.1 | — |
| SECONDARY Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit |
20.1; 18.7; 0.4; 0.0; 0.8; -0.2 | — |
Summary
The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 [NCT04020341] and 212390 [NCT04187144]).
Eligibility Criteria
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 ( ]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.
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 =12 to 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 per
Data sourced from ClinicalTrials.gov (NCT05630833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.