Urinary Tract Infections
Conditions
Keywords
Acute cystitis, Efficacy, Gepotidacin, Nitrofurantoin, Urinary Tract Infection, Japanese Female
Brief 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 \[NCT04187144\]).
Interventions
DRUGGepotidacin
Gepotidacin will be administered.
DRUGNitrofurantoin
Nitrofurantoin will be administered.
DRUGPlacebo
Placebo will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit | At TOC visit (Days 9 to 16) | TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose (Day 1) to Follow-up visit (Days 21 to 31) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. TEAE is defined as any AE with an onset date on or after treatment start date/time. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). |
| Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met). |
| Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC. |
| Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC. |
| Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes. |
| Number of Participants With Therapeutic Response (TR) at the TOC Visit | At TOC visit (Days 9 to 16) | TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. |
| Number of Participants With Clinical Outcome at the TOC Visit | At TOC visit (Days 9 to 16) | Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met). |
| Number of Participants With Clinical Response at the TOC Visit | At TOC visit (Days 9 to 16) | Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC. |
| Number of Participants With Microbiological Outcome at the TOC Visit | At TOC visit (Days 9 to 16) | Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC. |
| Number of Participants With Microbiological Response at the TOC Visit | At TOC visit (Days 9 to 16) | Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes. |
| Number of Participants With Investigator Assessed Clinical Response | At TOC visit (Days 9 to 16) | Clinical response as assessed by investigator at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as sufficient resolution of acute cystitis signs and symptoms such that no additional systemic AB was required for the current infection. No apparent response to treatment, use of additional systemic AB for the current infection and death related to acute cystitis prior to the visit was considered as Clinical failure. Indeterminate/Missing was defined as participant lost to follow-up and/or the clinical assessment was not undertaken, use of confounding systemic AB for another infection, and death prior to the visit where acute cystitis was clearly noncontributory. |
| Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs) | From first dose (Day 1) to Follow-up visit (Days 21 to 31) | An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Adverse events of special interest (AESI) for gepotidacin included clostridium difficile, cardiovascular & gastrointestinal events and potential acetylcholinesterase-inhibition AESIs. SAEs were coded using MedDRA. |
| Number of Participants With Urinalysis Dipstick Results | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Protein (PRO). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Positive, 2777.55 micromole per liter (µmol/l), \>=27775.5 µmol/l, 8332.65 µmol/l, 5 milligram/dl (mg/dL), 20 mg/dL, \>=80 mg/dL, 300 mg/dL, 1000 mg/dL, \>=5000 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, 2777.55 micromole per liter), GLU indicates parameter, Baseline is the visit and 2777.55 micromole per liter indicates the concentration/presence in the urine sample. Data is presented in similar way for other parameters. |
| Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QTcF. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. |
| Change From Baseline (CFB) in Vital Sign: Pulse Rate | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Plasma Concentrations of Gepotidacin | Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose | Blood samples were collected for plasma concentration of Gepotidacin. |
| Urine Concentrations of Gepotidacin | Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose | Urine samples were collected for urine concentration of Gepotidacin. |
| Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value |
| Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| 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 | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value |
| Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline (CFB) in Vital Sign: Temperature | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
Countries
Japan
Participant flow
Pre-assignment details
A total of 380 participants were enrolled in the study. Of these, 374 participants were included in the Intent-to-treat (ITT) population. The ITT population excluded 6 participants from a site with Good Clinical Practice (GCP) violation and therefore not a part of analysis population.
Participants by arm
| Arm | Count |
|---|---|
| Gepotidacin Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water. | 281 |
| Nitrofurantoin Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water. | 93 |
| Total | 374 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Gepotidacin | Nitrofurantoin | Total |
|---|---|---|---|
| Age, Continuous | 44.9 YEARS STANDARD_DEVIATION 18.78 | 46.4 YEARS STANDARD_DEVIATION 19.21 | 45.2 YEARS STANDARD_DEVIATION 18.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 281 Participants | 93 Participants | 374 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 281 Participants | 93 Participants | 374 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 281 | 0 / 93 |
| other Total, other adverse events | 174 / 281 | 8 / 93 |
| serious Total, serious adverse events | 2 / 281 | 0 / 93 |
Outcome results
Primary
Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Time frame: At TOC visit (Days 9 to 16)
Population: Micro-ITT NTF-S population. Participants in micro-ITT population whose baseline qualifying bacterial UP were susceptible to nitrofurantoin (NTF-S). Additionally, for the statistical analysis, therapeutic success data from the pooled global studies 204989 (NCT04020341) and 212390 (NCT04187144) were used to derive the predictive distribution, to assess the consistency of gepotidacin's therapeutic success in the current study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit | Therapeutic Success | 69 Participants |
| Gepotidacin | Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit | Therapeutic Failure | 14 Participants |
Comparison: As defined in Statistical Analysis Plan, consistency with the global studies is demonstrated if the success criterion for gepotidacin is set to require a therapeutic response rate greater than lower 10th percentile value of the predictive distribution.
Secondary
Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit | Baseline | 20.1 Units per Liter (U/L) | Standard Deviation 17.26 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit | CFB to On-Therapy | 0.4 Units per Liter (U/L) | Standard Deviation 11.28 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | 0.8 Units per Liter (U/L) | Standard Deviation 16.01 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | -0.2 Units per Liter (U/L) | Standard Deviation 4.49 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit | Baseline | 18.7 Units per Liter (U/L) | Standard Deviation 7.12 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit | CFB to On-Therapy | 0.0 Units per Liter (U/L) | Standard Deviation 3.85 |
Secondary
Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Albumin, Baseline | 44.7 gram per Liter (g/L) | Standard Deviation 2.51 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Albumin, CFB to On-Therapy | -0.4 gram per Liter (g/L) | Standard Deviation 2.19 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Albumin, CFB to Test-of-Cure | -1.3 gram per Liter (g/L) | Standard Deviation 2.36 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Protein, Baseline | 70.6 gram per Liter (g/L) | Standard Deviation 4.18 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Protein, CFB to On-Therapy | -0.8 gram per Liter (g/L) | Standard Deviation 3.5 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Protein, CFB to Test-of-Cure | -2.1 gram per Liter (g/L) | Standard Deviation 3.8 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Protein, CFB to On-Therapy | -0.7 gram per Liter (g/L) | Standard Deviation 3.71 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Albumin, Baseline | 44.1 gram per Liter (g/L) | Standard Deviation 2.91 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Protein, Baseline | 70.7 gram per Liter (g/L) | Standard Deviation 4.46 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Albumin, CFB to On-Therapy | -0.3 gram per Liter (g/L) | Standard Deviation 2.11 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Protein, CFB to Test-of-Cure | -2.3 gram per Liter (g/L) | Standard Deviation 3.72 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Albumin, CFB to Test-of-Cure | -1.2 gram per Liter (g/L) | Standard Deviation 2.26 |
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
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALP, Baseline | 68.9 International Units per Liter (IU/L) | Standard Deviation 22.09 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALP, CFB to On-Therapy | -0.1 International Units per Liter (IU/L) | Standard Deviation 6.1 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALP, CFB to Test-of-Cure | -2.9 International Units per Liter (IU/L) | Standard Deviation 7.12 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALT, Baseline | 17.0 International Units per Liter (IU/L) | Standard Deviation 16.8 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALT, CFB to On-Therapy | 1.2 International Units per Liter (IU/L) | Standard Deviation 6.16 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALT, CFB to Test-of-Cure | 0.6 International Units per Liter (IU/L) | Standard Deviation 12.59 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALT, CFB to On-Therapy | -0.2 International Units per Liter (IU/L) | Standard Deviation 3.28 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALP, Baseline | 68.4 International Units per Liter (IU/L) | Standard Deviation 22.18 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALT, Baseline | 16.7 International Units per Liter (IU/L) | Standard Deviation 11.11 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALP, CFB to On-Therapy | -0.4 International Units per Liter (IU/L) | Standard Deviation 8.1 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALT, CFB to Test-of-Cure | -1.1 International Units per Liter (IU/L) | Standard Deviation 5.98 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit | ALP, CFB to Test-of-Cure | -3.1 International Units per Liter (IU/L) | Standard Deviation 9.28 |
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
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | 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 | Calcium, Baseline | 2.319018 millimoles per liter (mmol/L) | Standard Deviation 0.081698 |
| Gepotidacin | 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 | Calcium, CFB to On-Therapy | -0.004536 millimoles per liter (mmol/L) | Standard Deviation 0.0766926 |
| Gepotidacin | 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 | Calcium, CFB to Test-of-Cure | -0.032315 millimoles per liter (mmol/L) | Standard Deviation 0.0855497 |
| Gepotidacin | 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 | Glucose, Baseline | 5.196605 millimoles per liter (mmol/L) | Standard Deviation 1.1351979 |
| Gepotidacin | 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 | Glucose, CFB to On-Therapy | 0.248377 millimoles per liter (mmol/L) | Standard Deviation 1.357578 |
| Gepotidacin | 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 | Glucose, CFB to Test-of-Cure | 0.057763 millimoles per liter (mmol/L) | Standard Deviation 1.1507851 |
| Gepotidacin | 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 | Potassium, Baseline | 4.13 millimoles per liter (mmol/L) | Standard Deviation 0.339 |
| Gepotidacin | 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 | Potassium, CFB to On-Therapy | 0.05 millimoles per liter (mmol/L) | Standard Deviation 0.329 |
| Gepotidacin | 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 | Potassium, CFB to Test-of-Cure | 0.00 millimoles per liter (mmol/L) | Standard Deviation 0.365 |
| Gepotidacin | 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 | Magnesium, Baseline | 0.862 millimoles per liter (mmol/L) | Standard Deviation 0.0605 |
| Gepotidacin | 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 | Magnesium, CFB to On-Therapy | -0.004 millimoles per liter (mmol/L) | Standard Deviation 0.0555 |
| Gepotidacin | 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 | Magnesium, CFB to Test-of-Cure | -0.010 millimoles per liter (mmol/L) | Standard Deviation 0.0569 |
| Gepotidacin | 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 | Phosphate, Baseline | 1.184963 millimoles per liter (mmol/L) | Standard Deviation 0.1593757 |
| Gepotidacin | 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 | Phosphate, CFB to On-Therapy | 0.009746 millimoles per liter (mmol/L) | Standard Deviation 0.1600765 |
| Gepotidacin | 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 | Phosphate, CFB to Test-of-Cure | 0.019541 millimoles per liter (mmol/L) | Standard Deviation 0.1736731 |
| Gepotidacin | 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 | Sodium, Baseline | 139.8 millimoles per liter (mmol/L) | Standard Deviation 2.25 |
| Gepotidacin | 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 | Sodium, CFB to On-Therapy | 0.1 millimoles per liter (mmol/L) | Standard Deviation 2.33 |
| Gepotidacin | 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 | Sodium, CFB to Test-of-Cure | 0.1 millimoles per liter (mmol/L) | Standard Deviation 2.52 |
| Gepotidacin | 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 | Urea Nitrogen, Baseline | 4.3094 millimoles per liter (mmol/L) | Standard Deviation 1.32217 |
| Gepotidacin | 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 | Urea Nitrogen, CFB to On-Therapy | -0.0948 millimoles per liter (mmol/L) | Standard Deviation 0.98541 |
| Gepotidacin | 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 | Urea Nitrogen, CFB to Test-of-Cure | 0.1423 millimoles per liter (mmol/L) | Standard Deviation 1.0778 |
| Nitrofurantoin | 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 | Magnesium, CFB to On-Therapy | -0.010 millimoles per liter (mmol/L) | Standard Deviation 0.0519 |
| Nitrofurantoin | 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 | Calcium, Baseline | 2.314716 millimoles per liter (mmol/L) | Standard Deviation 0.0868299 |
| Nitrofurantoin | 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 | Urea Nitrogen, Baseline | 4.4145 millimoles per liter (mmol/L) | Standard Deviation 1.33139 |
| Nitrofurantoin | 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 | Calcium, CFB to On-Therapy | -0.012341 millimoles per liter (mmol/L) | Standard Deviation 0.0695672 |
| Nitrofurantoin | 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 | Magnesium, CFB to Test-of-Cure | -0.014 millimoles per liter (mmol/L) | Standard Deviation 0.0651 |
| Nitrofurantoin | 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 | Calcium, CFB to Test-of-Cure | -0.029885 millimoles per liter (mmol/L) | Standard Deviation 0.0860459 |
| Nitrofurantoin | 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 | Sodium, CFB to On-Therapy | -0.2 millimoles per liter (mmol/L) | Standard Deviation 2.38 |
| Nitrofurantoin | 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 | Glucose, Baseline | 5.458483 millimoles per liter (mmol/L) | Standard Deviation 1.758932 |
| Nitrofurantoin | 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 | Phosphate, Baseline | 1.206882 millimoles per liter (mmol/L) | Standard Deviation 0.1775576 |
| Nitrofurantoin | 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 | Glucose, CFB to On-Therapy | 0.423189 millimoles per liter (mmol/L) | Standard Deviation 1.3092369 |
| Nitrofurantoin | 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 | Urea Nitrogen, CFB to Test-of-Cure | 0.1177 millimoles per liter (mmol/L) | Standard Deviation 0.91259 |
| Nitrofurantoin | 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 | Glucose, CFB to Test-of-Cure | 0.156160 millimoles per liter (mmol/L) | Standard Deviation 1.2016889 |
| Nitrofurantoin | 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 | Phosphate, CFB to On-Therapy | -0.031943 millimoles per liter (mmol/L) | Standard Deviation 0.17063 |
| Nitrofurantoin | 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 | Potassium, Baseline | 4.16 millimoles per liter (mmol/L) | Standard Deviation 0.364 |
| Nitrofurantoin | 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 | Sodium, CFB to Test-of-Cure | 0.2 millimoles per liter (mmol/L) | Standard Deviation 2.42 |
| Nitrofurantoin | 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 | Potassium, CFB to On-Therapy | 0.02 millimoles per liter (mmol/L) | Standard Deviation 0.31 |
| Nitrofurantoin | 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 | Phosphate, CFB to Test-of-Cure | 0.036903 millimoles per liter (mmol/L) | Standard Deviation 0.1985578 |
| Nitrofurantoin | 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 | Potassium, CFB to Test-of-Cure | 0.04 millimoles per liter (mmol/L) | Standard Deviation 0.37 |
| Nitrofurantoin | 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 | Urea Nitrogen, CFB to On-Therapy | -0.1689 millimoles per liter (mmol/L) | Standard Deviation 0.85458 |
| Nitrofurantoin | 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 | Magnesium, Baseline | 0.860 millimoles per liter (mmol/L) | Standard Deviation 0.0632 |
| Nitrofurantoin | 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 | Sodium, Baseline | 139.8 millimoles per liter (mmol/L) | Standard Deviation 2.13 |
Secondary
Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit | Baseline | 1.8346749 Milliliter/second (mL/s) | Standard Deviation 0.58199842 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit | CFB to On-Therapy | -0.1155781 Milliliter/second (mL/s) | Standard Deviation 0.27838072 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | -0.0284139 Milliliter/second (mL/s) | Standard Deviation 0.27653678 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit | Baseline | 1.8690338 Milliliter/second (mL/s) | Standard Deviation 0.6394409 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit | CFB to On-Therapy | 0.0331548 Milliliter/second (mL/s) | Standard Deviation 0.2839085 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | -0.0111724 Milliliter/second (mL/s) | Standard Deviation 0.24923906 |
Secondary
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Direct Bilirubin, CFB to On-Therapy | -0.0056 micromoles per Liter (umol/L) | Standard Deviation 0.24374 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Total Bilirubin, CFB to Test-of-Cure | -0.1723 micromoles per Liter (umol/L) | Standard Deviation 4.23182 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Total Bilirubin, Baseline | 7.0731 micromoles per Liter (umol/L) | Standard Deviation 4.66102 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Creatinine, Baseline | 50.964 micromoles per Liter (umol/L) | Standard Deviation 8.7527 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Direct Bilirubin, CFB to Test-of-Cure | -0.0063 micromoles per Liter (umol/L) | Standard Deviation 0.20804 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Creatinine, CFB to On-Therapy | 3.632 micromoles per Liter (umol/L) | Standard Deviation 6.6395 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Total Bilirubin, CFB to On-Therapy | -0.4079 micromoles per Liter (umol/L) | Standard Deviation 4.14317 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Creatinine, CFB to Test-of-Cure | 0.620 micromoles per Liter (umol/L) | Standard Deviation 7.9007 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Direct Bilirubin, Baseline | 3.4498 micromoles per Liter (umol/L) | Standard Deviation 0.23845 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Creatinine, CFB to Test-of-Cure | 0.000 micromoles per Liter (umol/L) | Standard Deviation 7.0965 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Direct Bilirubin, Baseline | 3.4329 micromoles per Liter (umol/L) | Standard Deviation 0.10767 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Direct Bilirubin, CFB to On-Therapy | -0.0129 micromoles per Liter (umol/L) | Standard Deviation 0.10767 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Direct Bilirubin, CFB to Test-of-Cure | -0.0113 micromoles per Liter (umol/L) | Standard Deviation 0.11053 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Total Bilirubin, Baseline | 6.0420 micromoles per Liter (umol/L) | Standard Deviation 3.11713 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Total Bilirubin, CFB to On-Therapy | 0.3163 micromoles per Liter (umol/L) | Standard Deviation 3.23527 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Total Bilirubin, CFB to Test-of-Cure | 0.2988 micromoles per Liter (umol/L) | Standard Deviation 2.99514 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Creatinine, Baseline | 52.280 micromoles per Liter (umol/L) | Standard Deviation 11.9212 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Creatinine, CFB to On-Therapy | -1.426 micromoles per Liter (umol/L) | Standard Deviation 6.9325 |
Secondary
Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit | Baseline | 102.3 Milliequivalents per liter (mEq/L) | Standard Deviation 2.21 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit | CFB to On-Therapy | 0.8 Milliequivalents per liter (mEq/L) | Standard Deviation 2.23 |
| Gepotidacin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | 1.0 Milliequivalents per liter (mEq/L) | Standard Deviation 2.46 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit | Baseline | 102.4 Milliequivalents per liter (mEq/L) | Standard Deviation 2.38 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit | CFB to On-Therapy | 0.3 Milliequivalents per liter (mEq/L) | Standard Deviation 2.36 |
| Nitrofurantoin | Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | 0.6 Milliequivalents per liter (mEq/L) | Standard Deviation 2.58 |
Secondary
Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate
Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate | Baseline | 67.2 beats/minute | Standard Deviation 10.18 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate | CFB to On-Therapy | -0.5 beats/minute | Standard Deviation 7.84 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate | CFB to Test-of-Cure | 0.5 beats/minute | Standard Deviation 8.44 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate | Baseline | 70.7 beats/minute | Standard Deviation 13.29 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate | CFB to On-Therapy | -3.3 beats/minute | Standard Deviation 12.41 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate | CFB to Test-of-Cure | -1.6 beats/minute | Standard Deviation 12.9 |
Secondary
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF
Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QTcF. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | PR, Baseline | 154.9 Millisecond (msec) | Standard Deviation 17.88 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | PR, CFB to On-Therapy | 1.6 Millisecond (msec) | Standard Deviation 12.18 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | PR, CFB to Test-of-Cure | 0.3 Millisecond (msec) | Standard Deviation 10.47 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QRS, Baseline | 88.1 Millisecond (msec) | Standard Deviation 10.06 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QRS, CFB to On-Therapy | 1.2 Millisecond (msec) | Standard Deviation 3.77 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QRS, CFB to Test-of-Cure | -0.6 Millisecond (msec) | Standard Deviation 3.72 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QT, Baseline | 404.5 Millisecond (msec) | Standard Deviation 28.16 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QT, CFB to On-Therapy | 10.4 Millisecond (msec) | Standard Deviation 23.67 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QT, CFB to Test-of-Cure | -0.7 Millisecond (msec) | Standard Deviation 24.53 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QTcF, Baseline | 418.3 Millisecond (msec) | Standard Deviation 17.75 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QTcF, CFB to On-Therapy | 10.3 Millisecond (msec) | Standard Deviation 13.44 |
| Gepotidacin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QTcF, CFB to Test-of-Cure | 1.3 Millisecond (msec) | Standard Deviation 12.09 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QTcF, CFB to On-Therapy | 1.8 Millisecond (msec) | Standard Deviation 10.82 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | PR, Baseline | 159.3 Millisecond (msec) | Standard Deviation 16.68 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QT, Baseline | 401.1 Millisecond (msec) | Standard Deviation 28.22 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | PR, CFB to On-Therapy | 1.4 Millisecond (msec) | Standard Deviation 9.96 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QTcF, Baseline | 423.2 Millisecond (msec) | Standard Deviation 17.25 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | PR, CFB to Test-of-Cure | 0.6 Millisecond (msec) | Standard Deviation 10.49 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QT, CFB to On-Therapy | 4.8 Millisecond (msec) | Standard Deviation 18.78 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QRS, Baseline | 89.8 Millisecond (msec) | Standard Deviation 9.78 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QTcF, CFB to Test-of-Cure | 3.6 Millisecond (msec) | Standard Deviation 11.66 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QRS, CFB to On-Therapy | 0.0 Millisecond (msec) | Standard Deviation 3.57 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QT, CFB to Test-of-Cure | 3.4 Millisecond (msec) | Standard Deviation 23.23 |
| Nitrofurantoin | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | QRS, CFB to Test-of-Cure | -0.5 Millisecond (msec) | Standard Deviation 3.57 |
Secondary
Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | Baseline | 4.302 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.365 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | CFB to On-Therapy | -0.040 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.2021 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | -0.085 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.2157 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | Baseline | 4.245 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.3758 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | CFB to On-Therapy | -0.025 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.1887 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | -0.098 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.2218 |
Secondary
Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | Baseline | 0.4355 Proportion of red blood cells in blood | Standard Deviation 0.04242 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | CFB to On-Therapy | -0.0047 Proportion of red blood cells in blood | Standard Deviation 0.03252 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | -0.0082 Proportion of red blood cells in blood | Standard Deviation 0.03441 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | Baseline | 0.4308 Proportion of red blood cells in blood | Standard Deviation 0.05058 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | CFB to On-Therapy | 0.0067 Proportion of red blood cells in blood | Standard Deviation 0.03567 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | -0.0038 Proportion of red blood cells in blood | Standard Deviation 0.03533 |
Secondary
Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit | Baseline | 128.6 Grams per Liter (g/L) | Standard Deviation 10.7 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit | CFB to On-Therapy | -1.3 Grams per Liter (g/L) | Standard Deviation 6.01 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | -2.3 Grams per Liter (g/L) | Standard Deviation 6.22 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit | Baseline | 128.0 Grams per Liter (g/L) | Standard Deviation 10.91 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit | CFB to On-Therapy | -1.0 Grams per Liter (g/L) | Standard Deviation 5.61 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | -2.9 Grams per Liter (g/L) | Standard Deviation 6.39 |
Secondary
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | Baseline | 29.97 Picogram (pg) | Standard Deviation 2.062 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | CFB to On-Therapy | -0.03 Picogram (pg) | Standard Deviation 0.536 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | 0.04 Picogram (pg) | Standard Deviation 0.613 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | Baseline | 30.26 Picogram (pg) | Standard Deviation 2.17 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | CFB to On-Therapy | -0.05 Picogram (pg) | Standard Deviation 0.519 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | 0.00 Picogram (pg) | Standard Deviation 0.629 |
Secondary
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | Baseline | 101.48 Femtoliter (fL) | Standard Deviation 8.607 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | CFB to On-Therapy | -0.16 Femtoliter (fL) | Standard Deviation 6.3 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | 0.08 Femtoliter (fL) | Standard Deviation 6.74 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | Baseline | 101.65 Femtoliter (fL) | Standard Deviation 10.185 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | CFB to On-Therapy | 2.40 Femtoliter (fL) | Standard Deviation 7.634 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | CFB to Test-of-Cure | 1.61 Femtoliter (fL) | Standard Deviation 7.071 |
Secondary
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Basophils, Baseline | 0.050 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0238 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Basophils, CFB to On-Therapy | -0.004 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0194 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Basophils, CFB to Test-of-Cure | -0.001 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0192 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Eosinophils, Baseline | 0.134 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1199 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Eosinophils, CFB to On-Therapy | 0.008 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0567 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Eosinophils, CFB to Test-of-Cure | 0.028 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0862 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Lymphocytes, Baseline | 1.657 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.5001 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Lymphocytes, CFB to On-Therapy | -0.044 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.3958 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Lymphocytes, CFB to Test-of-Cure | -0.054 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.4698 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Monocytes, Baseline | 0.388 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1474 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Monocytes, CFB to On-Therapy | -0.057 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1457 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Monocytes, CFB to Test-of-Cure | -0.049 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1503 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Neutrophils, Baseline | 4.805 Giga cells per Liter (10^9 cells/L) | Standard Deviation 2.1102 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Neutrophils, CFB to On-Therapy | -1.530 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.8841 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Neutrophils, CFB to Test-of-Cure | -1.713 Giga cells per Liter (10^9 cells/L) | Standard Deviation 2.2275 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Platelets, Baseline | 261.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 58.37 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Platelets, CFB to On-Therapy | 5.7 Giga cells per Liter (10^9 cells/L) | Standard Deviation 25.42 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Platelets, CFB to Test-of-Cure | 3.3 Giga cells per Liter (10^9 cells/L) | Standard Deviation 34.8 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Neutrophils, CFB to On-Therapy | -1.477 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.9168 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Basophils, Baseline | 0.051 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0223 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Monocytes, Baseline | 0.375 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1394 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Basophils, CFB to On-Therapy | -0.001 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0152 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Platelets, CFB to Test-of-Cure | 4.2 Giga cells per Liter (10^9 cells/L) | Standard Deviation 37.13 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Basophils, CFB to Test-of-Cure | -0.002 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0135 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Monocytes, CFB to On-Therapy | -0.059 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1584 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Eosinophils, Baseline | 0.121 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0977 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Neutrophils, CFB to Test-of-Cure | -1.493 Giga cells per Liter (10^9 cells/L) | Standard Deviation 2.1633 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Eosinophils, CFB to On-Therapy | 0.011 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.05 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Monocytes, CFB to Test-of-Cure | -0.033 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1393 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Eosinophils, CFB to Test-of-Cure | 0.023 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.063 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Platelets, CFB to On-Therapy | 2.6 Giga cells per Liter (10^9 cells/L) | Standard Deviation 21.53 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Lymphocytes, Baseline | 1.727 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.5203 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Neutrophils, Baseline | 4.684 Giga cells per Liter (10^9 cells/L) | Standard Deviation 2.0992 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Lymphocytes, CFB to On-Therapy | 0.075 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.4024 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Platelets, Baseline | 253.6 Giga cells per Liter (10^9 cells/L) | Standard Deviation 56.8 |
| Nitrofurantoin | Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit | Lymphocytes, CFB to Test-of-Cure | 0.111 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.4414 |
Secondary
Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Diastolic Blood Pressure, Baseline | 72.8 Millimeters of mercury (mmHg) | Standard Deviation 11.98 |
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Diastolic Blood Pressure, CFB to On-Therapy | -2.6 Millimeters of mercury (mmHg) | Standard Deviation 9.45 |
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Diastolic Blood Pressure, CFB to Test-of-Cure | -2.4 Millimeters of mercury (mmHg) | Standard Deviation 9.76 |
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Systolic Blood Pressure, Baseline | 118.2 Millimeters of mercury (mmHg) | Standard Deviation 18.1 |
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Systolic Blood Pressure, CFB to On-Therapy | -3.1 Millimeters of mercury (mmHg) | Standard Deviation 12.2 |
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Systolic Blood Pressure, CFB to Test-of-Cure | -3.7 Millimeters of mercury (mmHg) | Standard Deviation 11.63 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Systolic Blood Pressure, CFB to On-Therapy | -3.3 Millimeters of mercury (mmHg) | Standard Deviation 13.32 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Diastolic Blood Pressure, Baseline | 74.5 Millimeters of mercury (mmHg) | Standard Deviation 12.6 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Systolic Blood Pressure, Baseline | 118.7 Millimeters of mercury (mmHg) | Standard Deviation 18.38 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Diastolic Blood Pressure, CFB to On-Therapy | -2.1 Millimeters of mercury (mmHg) | Standard Deviation 9.36 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Systolic Blood Pressure, CFB to Test-of-Cure | -4.1 Millimeters of mercury (mmHg) | Standard Deviation 11.35 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Diastolic Blood Pressure, CFB to Test-of-Cure | -3.9 Millimeters of mercury (mmHg) | Standard Deviation 9.64 |
Secondary
Change From Baseline (CFB) in Vital Sign: Pulse Rate
Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Pulse Rate | Baseline | 69.7 beats/minute | Standard Deviation 10.79 |
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Pulse Rate | CFB to On-Therapy | 2.4 beats/minute | Standard Deviation 10.36 |
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Pulse Rate | CFB to Test-of-Cure | 0.4 beats/minute | Standard Deviation 9.3 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Pulse Rate | Baseline | 72.2 beats/minute | Standard Deviation 10.65 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Pulse Rate | CFB to On-Therapy | 1.4 beats/minute | Standard Deviation 10.66 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Pulse Rate | CFB to Test-of-Cure | -0.5 beats/minute | Standard Deviation 11.54 |
Secondary
Change From Baseline (CFB) in Vital Sign: Temperature
Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Temperature | Baseline | 36.49 Celsius | Standard Deviation 0.367 |
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Temperature | CFB to On-Therapy | -0.05 Celsius | Standard Deviation 0.453 |
| Gepotidacin | Change From Baseline (CFB) in Vital Sign: Temperature | CFB to Test-of-Cure | -0.07 Celsius | Standard Deviation 0.397 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Temperature | Baseline | 36.44 Celsius | Standard Deviation 0.365 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Temperature | CFB to On-Therapy | -0.03 Celsius | Standard Deviation 0.425 |
| Nitrofurantoin | Change From Baseline (CFB) in Vital Sign: Temperature | CFB to Test-of-Cure | -0.02 Celsius | Standard Deviation 0.396 |
Secondary
Number of Participants With Clinical Outcome at the TOC Visit
Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
Time frame: At TOC visit (Days 9 to 16)
Population: Micro-ITT MDR Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit | Clinical Resolution | 14 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit | Clinical Improvement | 2 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit | Clinical Worsening | 1 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit | Unable To Determine | 1 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit | Unable To Determine | 0 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit | Clinical Resolution | 2 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit | Clinical Worsening | 1 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit | Clinical Improvement | 0 Participants |
Secondary
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
Time frame: At TOC visit (Days 9 to 16)
Population: Micro-ITT NTF-S Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical Resolution | 71 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical Improvement | 5 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical Worsening | 3 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Unable To Determine | 4 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Unable To Determine | 0 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical Resolution | 19 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical Worsening | 2 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical Improvement | 4 Participants |
Secondary
Number of Participants With Clinical Response at the TOC Visit
Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.
Time frame: At TOC visit (Days 9 to 16)
Population: Micro-ITT MDR Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Clinical Response at the TOC Visit | Clinical Success | 14 Participants |
| Gepotidacin | Number of Participants With Clinical Response at the TOC Visit | Clinical Failure | 4 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit | Clinical Success | 2 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit | Clinical Failure | 1 Participants |
Secondary
Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population
Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.
Time frame: At TOC visit (Days 9 to 16)
Population: Micro-ITT NTF-S Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | Clinical Success | 71 Participants |
| Gepotidacin | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | Clinical Failure | 12 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | Clinical Success | 19 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | Clinical Failure | 6 Participants |
Secondary
Number of Participants With Investigator Assessed Clinical Response
Clinical response as assessed by investigator at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as sufficient resolution of acute cystitis signs and symptoms such that no additional systemic AB was required for the current infection. No apparent response to treatment, use of additional systemic AB for the current infection and death related to acute cystitis prior to the visit was considered as Clinical failure. Indeterminate/Missing was defined as participant lost to follow-up and/or the clinical assessment was not undertaken, use of confounding systemic AB for another infection, and death prior to the visit where acute cystitis was clearly noncontributory.
Time frame: At TOC visit (Days 9 to 16)
Population: ITT population: All participants (except for 6 participants from the site with GCP violation) were randomly assigned to the study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Investigator Assessed Clinical Response | Clinical Success | 242 Participants |
| Gepotidacin | Number of Participants With Investigator Assessed Clinical Response | Clinical Failure | 28 Participants |
| Gepotidacin | Number of Participants With Investigator Assessed Clinical Response | Indeterminate/Missing | 11 Participants |
| Nitrofurantoin | Number of Participants With Investigator Assessed Clinical Response | Clinical Success | 86 Participants |
| Nitrofurantoin | Number of Participants With Investigator Assessed Clinical Response | Clinical Failure | 6 Participants |
| Nitrofurantoin | Number of Participants With Investigator Assessed Clinical Response | Indeterminate/Missing | 1 Participants |
Secondary
Number of Participants With Microbiological Outcome at the TOC Visit
Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.
Time frame: At TOC visit (Days 9 to 16)
Population: Micro-ITT MDR Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Microbiological Outcome at the TOC Visit | Microbiological Eradication | 16 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome at the TOC Visit | Microbiological Persistence | 0 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome at the TOC Visit | Microbiological Recurrence | 0 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome at the TOC Visit | Unable To Determine | 2 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome at the TOC Visit | Unable To Determine | 1 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome at the TOC Visit | Microbiological Eradication | 2 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome at the TOC Visit | Microbiological Recurrence | 0 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome at the TOC Visit | Microbiological Persistence | 0 Participants |
Secondary
Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population
Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.
Time frame: At TOC visit (Days 9 to 16)
Population: Micro-ITT NTF-S Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | Microbiological Eradication (ME) | 74 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | Microbiological Persistence (MP) | 0 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | Microbiological Recurrence (MR) | 1 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | Unable To Determine (UTD) | 8 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | Unable To Determine (UTD) | 2 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | Microbiological Eradication (ME) | 20 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | Microbiological Recurrence (MR) | 3 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | Microbiological Persistence (MP) | 0 Participants |
Secondary
Number of Participants With Microbiological Response at the TOC Visit
Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.
Time frame: At TOC visit (Days 9 to 16)
Population: Micro-ITT MDR Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Microbiological Response at the TOC Visit | Microbiological Success | 16 Participants |
| Gepotidacin | Number of Participants With Microbiological Response at the TOC Visit | Microbiological Failure | 2 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the TOC Visit | Microbiological Success | 2 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the TOC Visit | Microbiological Failure | 1 Participants |
Secondary
Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population
Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.
Time frame: At TOC visit (Days 9 to 16)
Population: Micro-ITT NTF-S Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population | Microbiological Success | 74 Participants |
| Gepotidacin | Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population | Microbiological Failure | 9 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population | Microbiological Success | 20 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population | Microbiological Failure | 5 Participants |
Secondary
Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs)
An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Adverse events of special interest (AESI) for gepotidacin included clostridium difficile, cardiovascular & gastrointestinal events and potential acetylcholinesterase-inhibition AESIs. SAEs were coded using MedDRA.
Time frame: From first dose (Day 1) to Follow-up visit (Days 21 to 31)
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs) | Serious AE (SAE) | 2 Participants |
| Gepotidacin | Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs) | AE of Special Interest (AESIs) | 191 Participants |
| Nitrofurantoin | Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs) | Serious AE (SAE) | 0 Participants |
| Nitrofurantoin | Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs) | AE of Special Interest (AESIs) | 12 Participants |
Secondary
Number of Participants With Therapeutic Response (TR) at the TOC Visit
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Time frame: At TOC visit (Days 9 to 16)
Population: Microbiological intent-to-treat multi drug resistant (Micro-ITT MDR) population included all participants in the micro-ITT Population who had any qualifying baseline bacterial uropathogens that were resistant to two or more classes of antimicrobials.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Therapeutic Response (TR) at the TOC Visit | Therapeutic Success | 14 Participants |
| Gepotidacin | Number of Participants With Therapeutic Response (TR) at the TOC Visit | Therapeutic Failure | 4 Participants |
| Nitrofurantoin | Number of Participants With Therapeutic Response (TR) at the TOC Visit | Therapeutic Success | 2 Participants |
| Nitrofurantoin | Number of Participants With Therapeutic Response (TR) at the TOC Visit | Therapeutic Failure | 1 Participants |
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
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Time frame: At TOC visit (Days 9 to 16)
Population: Micro-ITT NTF-S Population. Participants in the micro-ITT Population whose baseline qualifying bacterial UP were susceptible to nitrofurantoin (NTF-S).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | Therapeutic Success | 69 Participants |
| Gepotidacin | Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | Therapeutic Failure | 14 Participants |
| Nitrofurantoin | Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | Therapeutic Success | 17 Participants |
| Nitrofurantoin | Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | Therapeutic Failure | 8 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. TEAE is defined as any AE with an onset date on or after treatment start date/time. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: From first dose (Day 1) to Follow-up visit (Days 21 to 31)
Population: Safety Population included all randomized participants (except for 6 participants from the site with GCP violation) who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gepotidacin | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 201 Participants |
| Nitrofurantoin | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 18 Participants |
Secondary
Number of Participants With Urinalysis Dipstick Results
Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Protein (PRO). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Positive, 2777.55 micromole per liter (µmol/l), \>=27775.5 µmol/l, 8332.65 µmol/l, 5 milligram/dl (mg/dL), 20 mg/dL, \>=80 mg/dL, 300 mg/dL, 1000 mg/dL, \>=5000 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, 2777.55 micromole per liter), GLU indicates parameter, Baseline is the visit and 2777.55 micromole per liter indicates the concentration/presence in the urine sample. Data is presented in similar way for other parameters.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, 2777.55 micromole per liter | 3 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, >=27775.5 micromole per liter | 4 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, NEGATIVE | 273 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, 2777.55 micromole per liter | 5 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, 8332.65 micromole per liter | 2 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, >=27775.5 micromole per liter | 2 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, NEGATIVE | 266 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Test-of-Cure, 2777.55 micromole per liter | 1 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Test-of-Cure, 8332.65 micromole per liter | 1 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Test-of-Cure, >=27775.5 micromole per liter | 3 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Test-of-Cure, NEGATIVE | 267 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, 20 milligrams per deciliter | 10 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, 5 milligrams per deciliter | 26 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, NEGATIVE | 244 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, 20 milligrams per deciliter | 6 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, 5 milligrams per deciliter | 22 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, >=80 milligrams per deciliter | 0 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, NEGATIVE | 247 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Test-of-Cure, 20 milligrams per deciliter | 1 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Test-of-Cure, 5 milligrams per deciliter | 18 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Test-of-Cure, NEGATIVE | 253 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, Baseline, NEGATIVE | 212 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, Baseline, POSITIVE | 68 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, On-Therapy, NEGATIVE | 275 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, On-Therapy, POSITIVE | 0 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, Test-of-Cure, NEGATIVE | 256 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, Test-of-Cure, POSITIVE | 16 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, 1000 milligrams per deciliter | 43 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO Baseline, 300 milligrams per deciliter | 63 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, >=5000 milligrams per deciliter | 15 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, NEGATIVE | 159 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, 1000 milligrams per deciliter | 12 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, 300 milligrams per deciliter | 46 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, >=5000 milligrams per deciliter | 2 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, NEGATIVE | 215 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Test-of-Cure, 1000 milligrams per deciliter | 13 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Test-of-Cure, 300 milligrams per deciliter | 24 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Test-of-Cure, >=5000 milligrams per deciliter | 0 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Test-of-Cure, NEGATIVE | 235 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Test-of-Cure, 5 milligrams per deciliter | 13 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, 2777.55 micromole per liter | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, >=5000 milligrams per deciliter | 4 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, >=27775.5 micromole per liter | 5 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Test-of-Cure, NEGATIVE | 79 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, NEGATIVE | 87 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, NEGATIVE | 75 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, 2777.55 micromole per liter | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, Baseline, NEGATIVE | 75 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, 8332.65 micromole per liter | 0 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, NEGATIVE | 45 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, >=27775.5 micromole per liter | 6 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, Baseline, POSITIVE | 18 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, NEGATIVE | 86 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Test-of-Cure, NEGATIVE | 79 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Test-of-Cure, 2777.55 micromole per liter | 3 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, On-Therapy, NEGATIVE | 90 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Test-of-Cure, 8332.65 micromole per liter | 0 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, 1000 milligrams per deciliter | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Test-of-Cure, >=27775.5 micromole per liter | 6 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, On-Therapy, POSITIVE | 3 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Test-of-Cure, NEGATIVE | 83 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Test-of-Cure, 1000 milligrams per deciliter | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, 20 milligrams per deciliter | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, Test-of-Cure, NEGATIVE | 86 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, 5 milligrams per deciliter | 13 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, 300 milligrams per deciliter | 17 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, NEGATIVE | 79 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, Test-of-Cure, POSITIVE | 6 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, 20 milligrams per deciliter | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Test-of-Cure, >=5000 milligrams per deciliter | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, 5 milligrams per deciliter | 7 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, 1000 milligrams per deciliter | 19 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, >=80 milligrams per deciliter | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, >=5000 milligrams per deciliter | 0 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, NEGATIVE | 84 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO Baseline, 300 milligrams per deciliter | 25 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Test-of-Cure, 20 milligrams per deciliter | 0 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Test-of-Cure, 300 milligrams per deciliter | 11 Participants |
Secondary
Plasma Concentrations of Gepotidacin
Blood samples were collected for plasma concentration of Gepotidacin.
Time frame: Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose
Population: Pharmacokinetic (PK) Population included all randomized participants (excluding 6 participants from a site with GCP violation), who received at least 1 dose of Gepotidacin and had at least 1 non-missing plasma concentration (Non-quantifiable values were considered as non-missing). Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Plasma Concentrations of Gepotidacin | Baseline, POST-DOSE, Day 1, 0-2h | 5210.23 Nanogram/ milliliter (ng/mL) | Standard Deviation 3428.432 |
| Gepotidacin | Plasma Concentrations of Gepotidacin | Baseline, POST-DOSE, Day 1, >2h | 5251.54 Nanogram/ milliliter (ng/mL) | Standard Deviation 2097.649 |
| Gepotidacin | Plasma Concentrations of Gepotidacin | On-Therapy, PRE-DOSE, Day 2-5, pre-dose | 1960.14 Nanogram/ milliliter (ng/mL) | Standard Deviation 16752.767 |
| Gepotidacin | Plasma Concentrations of Gepotidacin | On-Therapy, POST-DOSE, Day 2-5, 0-2h | 17548.67 Nanogram/ milliliter (ng/mL) | Standard Deviation 124724.24 |
| Gepotidacin | Plasma Concentrations of Gepotidacin | On-Therapy, POST-DOSE, Day 2-5, >2h | 5976.40 Nanogram/ milliliter (ng/mL) | Standard Deviation 5142.635 |
Secondary
Urine Concentrations of Gepotidacin
Urine samples were collected for urine concentration of Gepotidacin.
Time frame: Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose
Population: Pharmacokinetic (PK) Population included all randomized participants (excluding 6 participants from a site with GCP violation), who received at least 1 dose of Gepotidacin and had at least 1 non-missing urine concentration (Non-quantifiable values were considered as non-missing). Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Urine Concentrations of Gepotidacin | Baseline, POST-DOSE, Day 1, 0-2h | 506.988 Microgram/ milliliter (ug/mL) | Standard Deviation 914.314 |
| Gepotidacin | Urine Concentrations of Gepotidacin | Baseline, POST-DOSE, Day 1, >2h | 600.729 Microgram/ milliliter (ug/mL) | Standard Deviation 644.2265 |
| Gepotidacin | Urine Concentrations of Gepotidacin | On-Therapy, PRE-DOSE, Day 2-5, pre-dose | 492.096 Microgram/ milliliter (ug/mL) | Standard Deviation 565.8822 |
| Gepotidacin | Urine Concentrations of Gepotidacin | On-Therapy, POST-DOSE, Day 2-5, 0-2h | 901.554 Microgram/ milliliter (ug/mL) | Standard Deviation 1451.8781 |
| Gepotidacin | Urine Concentrations of Gepotidacin | On-Therapy, POST-DOSE, Day 2-5, >2h | 1138.900 Microgram/ milliliter (ug/mL) | Standard Deviation 1429.7998 |