Urinary Tract Infections
Conditions
Keywords
Acute cystitis, Efficacy, Gepotidacin, Nitrofurantoin, Urinary Tract Infection, Simple cystitis
Brief summary
The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
Interventions
DRUGGepotidacin
Gepotidacin will be available as tablets at a unit dose strength of 750mg. Participants will administer two 750 mg tablets, BID. Each dose will be taken with water after consumption of food.
Placebo matching nitrofurantoin will be available as over-encapsulated unit-dose capsules. Participants will administer 1 capsule BID. Each dose should be taken with water after consumption of food.
DRUGNitrofurantoin
Nitrofurantoin will be available as over-encapsulated 100 mg capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. Participants will administer one 100 mg capsule, BID. Each dose should be taken with water after consumption of food.
Placebo matching gepotidacin will be available as unit-dose gepotidacin placebo-to-match tablet. Participants will administer two tablets, BID. Each dose should be taken with water after consumption of food.
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 is \>=12 years of age at the time of signing the informed consent/assent and has a body weight \>=40 kilogram (kg). * The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset \<96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain. * 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 female. * 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 has a history of sensitivity to the study treatment, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates her participation. * 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: 1. Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain,; Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; Or 2. Known acute porphyria. 3. 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 has a serious underlying disease that could be imminently life threatening, or the participant is unlikely to survive for the duration of the study period. * The participant has acute 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 Escherichia 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 (for example \[e.g.\], polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesico-ureteral 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 \>=101.4 degree Fahrenheit (\>=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 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. * 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 ALT value \>2 times upper limit of normal (ULN). * The participant has a known 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 Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | 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 Baseline \[BL\] 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 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 Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | 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 Baseline \[BL\] 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 Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | 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 | TOC Visit (Days 9 to 16) | Participant-level MOs at TOC were 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 | 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)s 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) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | TR at FU was categorized as therapeutic success and therapeutic failure. A therapeutic success at FU referred to participants who have been deemed both a microbiological success (reduction of all QUPs recovered at BL to \<10\^3 CFU/mL, following microbiological eradication at the TOC visit, without receiving other AB before the FU visit) and a clinical success (resolution of signs and symptoms of acute cystitis demonstrated at the TOC visit persist at the FU visit and no new signs and symptoms, without receiving other AB before the FU visit \[or AB for uUTI on day of FU visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. |
| Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Clinical outcomes at FU were categorized as SCR, DCR, CI, CW, CR and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at the TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. Unable to determine outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for the current infection (uUTI) prior to the assessment (unless CS or CR outcome criteria were met). |
| Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure. |
| Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Participant-level MOs at FU were categorized as sustained microbiological eradication (SME), microbiological recurrence (MR), microbiological persistence (MP), delayed microbiological eradication (DME) and unable to determine (UTD). SME at FU was defined as all baseline QUPs had an outcome of sustained eradication at FU (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the FU Visit). MR at FU was defined as at least one QUP had an outcome of recurrence (≥10\^3 CFU/mL) and none had an outcome of persistence at FU. MP at FU was defined as at least one QUP had an outcome of persistence at FU. DME at FU was defined as at least one QUP had an outcome of delayed eradication and none had an outcome of persistence or recurrence at FU. UTD at FU was defined as all QUP outcomes were unable to determine at FU. |
| Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | FU visit (Days 21 to 31) | Participant- level microbiological response at FU was categorized as microbiological success and microbiological failure. Microbiological success at FU was defined as all baseline QUPs had a microbiological outcome of sustained eradication at FU visit. Microbiological failure at FU was defined as not meeting criteria of microbiological success including those participants with UTD outcome. |
| Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | TOC visit (Days 9 to 16) | Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution symptoms of acute cystitis present at baseline (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 - Intent-to-Treat (ITT) Population | 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 signs and 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. |
| Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | FU visit (Days 21 to 31) | Clinical outcomes at FU were categorized as Sustained Clinical Response (SCR), Delayed Clinical Response (DCR), CI, CW, Clinical Recurrence (CR) and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. UTD outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for current infection (uUTI) prior to assessment (unless CS or CR outcome criteria were met). |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From the time of first dose (Day 1) through the final follow-up visit (Day 21-31) | 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. |
| Number of Participants With Serious Adverse Events (SAEs) | From the time of first dose (Day 1) through the final follow-up visit (Day 21-31) | 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. |
| Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16) | Blood samples were collected for the analysis of hematology parameters: neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline in Hematology Parameter: Hemoglobin Level | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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. |
| Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | FU visit (Days 21 to 31) | Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure. |
| Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Clinical Chemistry Parameters: Albumin and Protein Levels | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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. |
| Number of Participants With Urinalysis Dipstick Results | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16) | Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Protein (PRO), Urine Occult Blood (BLO), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Leukocyte Esterase (LEU). 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, Trace, Small, Moderate, Large, Positive, 50 milligram per deciliter (mg/dL), 150 mg/dL, \>=500 mg/dL, 30 mg/dL, 100 mg/dL, 200 mg/dL, 5 mg/dL, 20 mg/dL, \>=80 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, Negative), GLU indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Data is presented in similar way for others parameters. |
| Absolute Mean Values of Urine Specific Gravity | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16) | Urine samples were collected from participants to assess urine specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Absolute Mean Values of Urine Potential of Hydrogen (pH) | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16) | Urine samples were collected from participants to assess urine pH levels. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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. |
| Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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. |
| Change From Baseline in Body Temperature | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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. |
| Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | Up to Day 31 | Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles \<=450, \>450 to \<=480, \>480 to \<=500 millisecond (msec) are the values at baseline. The category titles \<= 30, 31-60, \>60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented. |
| Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | Up to Day 31 | Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles \<=450 msec, \>450 msec to \<=480 msec are the values at baseline. The category titles \<= 30, 31-60, \>60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented. |
| Change From Baseline in Hematology Parameter: Hematocrit Level | Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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. |
| Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | TOC visit (Days 9 to 16) | Clinical outcomes at TOC were 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 baseline (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). |
Countries
Australia, Bulgaria, India, Poland, South Korea, United States
Participant flow
Recruitment details
1605 unique participants were enrolled in the study including one participant that was randomized twice in error. This participant signed two different informed consent forms, therefore that participant was counted as enrolling twice.
Participants by arm
| Arm | Count |
|---|---|
| Gepotidacin Participants with uncomplicated urinary tract infection (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. | 805 |
| 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. | 800 |
| Total | 1,605 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 19 | 4 |
| Overall Study | Lost to Follow-up | 12 | 11 |
| Overall Study | Physician Decision | 5 | 3 |
| Overall Study | Protocol Deviation | 1 | 4 |
| Overall Study | Screening Failure due to creatinine clearance and body mass index | 0 | 1 |
| Overall Study | Withdrawal by Subject | 20 | 18 |
Baseline characteristics
| Characteristic | Total | Nitrofurantoin | Gepotidacin |
|---|---|---|---|
| Age, Continuous | 48.3 Years STANDARD_DEVIATION 17.77 | 48.4 Years STANDARD_DEVIATION 17.72 | 48.2 Years STANDARD_DEVIATION 17.84 |
| Age, Customized Less than (<) 18 years | 11 Participants | 3 Participants | 8 Participants |
| Age, Customized More than (>) 50 years | 737 Participants | 367 Participants | 370 Participants |
| Age, Customized More than or equal to (>=) 18 years to 50 years | 857 Participants | 430 Participants | 427 Participants |
| Baseline Acute Cystitis Recurrence Non-Recurrent Infection | 933 Participants | 462 Participants | 471 Participants |
| Baseline Acute Cystitis Recurrence Recurrent Infection | 672 Participants | 338 Participants | 334 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 478 Participants | 232 Participants | 246 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1127 Participants | 568 Participants | 559 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 116 Participants | 65 Participants | 51 Participants |
| Race (NIH/OMB) Black or African American | 136 Participants | 62 Participants | 74 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 1342 Participants | 668 Participants | 674 Participants |
| Sex/Gender, Customized Female | 1605 Participants | 800 Participants | 805 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 804 | 0 / 798 |
| other Total, other adverse events | 235 / 804 | 119 / 798 |
| serious Total, serious adverse events | 5 / 804 | 5 / 798 |
Outcome results
Primary
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set)
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 Baseline \[BL\] 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 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: TOC visit (Days 9 to 16)
Population: Microbiological intent-to-treat susceptible to nitrofurantoin - (Micro-ITT NTF-S) (Interim Analysis \[IA\] Set) population included participants in the micro ITT NTF-S who per the interim analysis data had the opportunity to reach their Test of Cure (TOC) visit, or had not yet reached their TOC visit, but were already known to be failures.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | Therapeutic Success | 162 Participants |
| Gepotidacin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | Therapeutic Failure | 115 Participants |
| Nitrofurantoin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | Therapeutic Success | 115 Participants |
| Nitrofurantoin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) | Therapeutic Failure | 149 Participants |
95% CI: [6.4, 22.8]
Comparison: The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.018 p-value boundaryp-value: 0.000395% CI: [6.4, 22.8]1-sided p-value for Test of Superiority
Primary
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) 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 Baseline \[BL\] 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: TOC visit (Days 9 to 16)
Population: Micro-ITT NTF-S population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | Therapeutic Success | 172 Participants |
| Gepotidacin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | Therapeutic Failure | 120 Participants |
| Nitrofurantoin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | Therapeutic Success | 121 Participants |
| Nitrofurantoin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S Population | Therapeutic Failure | 154 Participants |
Secondary
Absolute Mean Values of Urine Potential of Hydrogen (pH)
Urine samples were collected from participants to assess urine pH levels. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 | Absolute Mean Values of Urine Potential of Hydrogen (pH) | pH, Baseline | 5.7 pH | Standard Deviation 0.8 |
| Gepotidacin | Absolute Mean Values of Urine Potential of Hydrogen (pH) | pH, On-Therapy | 5.6 pH | Standard Deviation 0.66 |
| Gepotidacin | Absolute Mean Values of Urine Potential of Hydrogen (pH) | pH, Test of Cure | 5.6 pH | Standard Deviation 0.69 |
| Nitrofurantoin | Absolute Mean Values of Urine Potential of Hydrogen (pH) | pH, Baseline | 5.7 pH | Standard Deviation 0.79 |
| Nitrofurantoin | Absolute Mean Values of Urine Potential of Hydrogen (pH) | pH, On-Therapy | 5.6 pH | Standard Deviation 0.69 |
| Nitrofurantoin | Absolute Mean Values of Urine Potential of Hydrogen (pH) | pH, Test of Cure | 5.7 pH | Standard Deviation 0.71 |
Secondary
Absolute Mean Values of Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 | Absolute Mean Values of Urine Specific Gravity | Baseline | 1.0172 Ratio | Standard Deviation 0.00693 |
| Gepotidacin | Absolute Mean Values of Urine Specific Gravity | On-Therapy | 1.0176 Ratio | Standard Deviation 0.00716 |
| Gepotidacin | Absolute Mean Values of Urine Specific Gravity | Test of Cure | 1.0179 Ratio | Standard Deviation 0.00712 |
| Nitrofurantoin | Absolute Mean Values of Urine Specific Gravity | Baseline | 1.0174 Ratio | Standard Deviation 0.00686 |
| Nitrofurantoin | Absolute Mean Values of Urine Specific Gravity | On-Therapy | 1.0167 Ratio | Standard Deviation 0.00696 |
| Nitrofurantoin | Absolute Mean Values of Urine Specific Gravity | Test of Cure | 1.0179 Ratio | Standard Deviation 0.00719 |
Secondary
Change From Baseline in Body 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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Body Temperature | Temperature, Baseline | 36.61 Celsius | Standard Deviation 0.346 |
| Gepotidacin | Change From Baseline in Body Temperature | Temperature, On-Therapy | -0.01 Celsius | Standard Deviation 0.334 |
| Gepotidacin | Change From Baseline in Body Temperature | Temperature, Test of Cure | -0.01 Celsius | Standard Deviation 0.349 |
| Nitrofurantoin | Change From Baseline in Body Temperature | Temperature, Baseline | 36.63 Celsius | Standard Deviation 0.317 |
| Nitrofurantoin | Change From Baseline in Body Temperature | Temperature, On-Therapy | -0.01 Celsius | Standard Deviation 0.372 |
| Nitrofurantoin | Change From Baseline in Body Temperature | Temperature, Test of Cure | -0.04 Celsius | Standard Deviation 0.351 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels
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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Albumin, Baseline | 45.2 gram per Liter (g/L) | Standard Deviation 3.33 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Albumin, On-Therapy | -0.4 gram per Liter (g/L) | Standard Deviation 2.38 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Albumin, Test of Cure | -0.5 gram per Liter (g/L) | Standard Deviation 2.65 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Protein, Baseline | 71.5 gram per Liter (g/L) | Standard Deviation 5.12 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Protein, On-Therapy | -0.7 gram per Liter (g/L) | Standard Deviation 3.71 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Protein, Test of Cure | -1.0 gram per Liter (g/L) | Standard Deviation 4.19 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Protein, On-Therapy | -1.2 gram per Liter (g/L) | Standard Deviation 3.89 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Albumin, Baseline | 45.2 gram per Liter (g/L) | Standard Deviation 3.11 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Protein, Baseline | 71.6 gram per Liter (g/L) | Standard Deviation 4.72 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Albumin, On-Therapy | -0.8 gram per Liter (g/L) | Standard Deviation 2.56 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Protein, Test of Cure | -1.1 gram per Liter (g/L) | Standard Deviation 4.32 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels | Serum Albumin, Test of Cure | -0.6 gram per Liter (g/L) | Standard Deviation 2.84 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels
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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALT, Test of Cure | 0.4 Units per Liter (U/L) | Standard Deviation 15.81 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum AST, Test of Cure | 0.9 Units per Liter (U/L) | Standard Deviation 9.89 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALT, On-Therapy | 0.2 Units per Liter (U/L) | Standard Deviation 10.8 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALP, Baseline | 81.4 Units per Liter (U/L) | Standard Deviation 29.96 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALT, Baseline | 20.3 Units per Liter (U/L) | Standard Deviation 20.34 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALP, On- Therapy | -0.5 Units per Liter (U/L) | Standard Deviation 9.61 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum AST, On-Therapy | 0.1 Units per Liter (U/L) | Standard Deviation 9.83 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALP, Test of Cure | -1.0 Units per Liter (U/L) | Standard Deviation 12 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum AST, Baseline | 21.0 Units per Liter (U/L) | Standard Deviation 13.72 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALP, Test of Cure | -0.4 Units per Liter (U/L) | Standard Deviation 15.38 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum AST, Baseline | 20.2 Units per Liter (U/L) | Standard Deviation 10.48 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALT, Test of Cure | -0.2 Units per Liter (U/L) | Standard Deviation 9.93 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALT, Baseline | 19.5 Units per Liter (U/L) | Standard Deviation 14.66 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALT, On-Therapy | -0.1 Units per Liter (U/L) | Standard Deviation 7.9 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum AST, On-Therapy | 0.0 Units per Liter (U/L) | Standard Deviation 7.9 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum AST, Test of Cure | -0.5 Units per Liter (U/L) | Standard Deviation 8.29 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALP, Baseline | 81.7 Units per Liter (U/L) | Standard Deviation 28.99 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels | Serum ALP, On- Therapy | -0.1 Units per Liter (U/L) | Standard Deviation 12.91 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels
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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Chloride, Baseline | 101.0 millimoles per liter (mmol/L) | Standard Deviation 3.27 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Urea Nitrogen, On- Therapy | -0.056 millimoles per liter (mmol/L) | Standard Deviation 1.4269 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Urea Nitrogen, Test of Cure | 0.022 millimoles per liter (mmol/L) | Standard Deviation 1.4 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Calcium, Baseline | 2.363 millimoles per liter (mmol/L) | Standard Deviation 0.1196 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Calcium, On-Therapy | -0.010 millimoles per liter (mmol/L) | Standard Deviation 0.095 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Calcium, Test of Cure | -0.014 millimoles per liter (mmol/L) | Standard Deviation 0.107 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Urea Nitrogen, Baseline | 4.742 millimoles per liter (mmol/L) | Standard Deviation 2.1107 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Chloride, On-Therapy | 0.3 millimoles per liter (mmol/L) | Standard Deviation 2.8 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Chloride, Test of Cure | 0.4 millimoles per liter (mmol/L) | Standard Deviation 2.93 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Glucose, Baseline | 5.590 millimoles per liter (mmol/L) | Standard Deviation 1.998 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Glucose, On-Therapy | 0.230 millimoles per liter (mmol/L) | Standard Deviation 1.512 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Glucose, Test of Cure | 0.215 millimoles per liter (mmol/L) | Standard Deviation 1.4412 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Magnesium, Baseline | 0.839 millimoles per liter (mmol/L) | Standard Deviation 0.0749 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Magnesium, On-Therapy | -0.001 millimoles per liter (mmol/L) | Standard Deviation 0.0635 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Magnesium, Test of Cure | -0.011 millimoles per liter (mmol/L) | Standard Deviation 0.0674 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Potassium, Baseline | 4.32 millimoles per liter (mmol/L) | Standard Deviation 0.414 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Potassium, On-Therapy | -0.04 millimoles per liter (mmol/L) | Standard Deviation 0.417 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Potassium, Test of Cure | -0.03 millimoles per liter (mmol/L) | Standard Deviation 0.438 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Phosphate, Baseline | 1.141 millimoles per liter (mmol/L) | Standard Deviation 0.1828 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Phosphate, On-Therapy | -0.005 millimoles per liter (mmol/L) | Standard Deviation 0.1782 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Phosphate, Test of Cure | 0.002 millimoles per liter (mmol/L) | Standard Deviation 0.1851 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Sodium, Baseline | 138.8 millimoles per liter (mmol/L) | Standard Deviation 2.64 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Sodium, On-Therapy | 0.0 millimoles per liter (mmol/L) | Standard Deviation 2.64 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Sodium, Test of Cure | 0.2 millimoles per liter (mmol/L) | Standard Deviation 2.91 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Sodium, On-Therapy | -0.2 millimoles per liter (mmol/L) | Standard Deviation 2.64 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Urea Nitrogen, Baseline | 4.724 millimoles per liter (mmol/L) | Standard Deviation 1.8645 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Magnesium, Baseline | 0.835 millimoles per liter (mmol/L) | Standard Deviation 0.0802 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Urea Nitrogen, On- Therapy | -0.018 millimoles per liter (mmol/L) | Standard Deviation 1.1663 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Phosphate, Baseline | 1.139 millimoles per liter (mmol/L) | Standard Deviation 0.1725 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Urea Nitrogen, Test of Cure | 0.131 millimoles per liter (mmol/L) | Standard Deviation 1.4826 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Magnesium, On-Therapy | -0.015 millimoles per liter (mmol/L) | Standard Deviation 0.0616 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Calcium, Baseline | 2.362 millimoles per liter (mmol/L) | Standard Deviation 0.1083 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Sodium, Baseline | 138.8 millimoles per liter (mmol/L) | Standard Deviation 2.76 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Calcium, On-Therapy | -0.018 millimoles per liter (mmol/L) | Standard Deviation 0.0944 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Magnesium, Test of Cure | -0.015 millimoles per liter (mmol/L) | Standard Deviation 0.0689 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Calcium, Test of Cure | -0.016 millimoles per liter (mmol/L) | Standard Deviation 0.0981 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Phosphate, On-Therapy | -0.027 millimoles per liter (mmol/L) | Standard Deviation 0.1836 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Chloride, Baseline | 100.9 millimoles per liter (mmol/L) | Standard Deviation 3.27 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Potassium, Baseline | 4.27 millimoles per liter (mmol/L) | Standard Deviation 0.415 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Chloride, On-Therapy | 0.1 millimoles per liter (mmol/L) | Standard Deviation 2.85 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Sodium, Test of Cure | 0.1 millimoles per liter (mmol/L) | Standard Deviation 2.91 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Chloride, Test of Cure | 0.4 millimoles per liter (mmol/L) | Standard Deviation 3.02 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Potassium, On-Therapy | -0.03 millimoles per liter (mmol/L) | Standard Deviation 0.428 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Glucose, Baseline | 5.719 millimoles per liter (mmol/L) | Standard Deviation 2.1915 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Phosphate, Test of Cure | -0.004 millimoles per liter (mmol/L) | Standard Deviation 0.1939 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Glucose, On-Therapy | 0.328 millimoles per liter (mmol/L) | Standard Deviation 1.938 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Potassium, Test of Cure | 0.00 millimoles per liter (mmol/L) | Standard Deviation 0.461 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels | Serum Glucose, Test of Cure | 0.266 millimoles per liter (mmol/L) | Standard Deviation 1.6667 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels
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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Direct Bilirubin, On- Therapy | -0.18 micromoles per Liter (umol/L) | Standard Deviation 1.192 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Total Bilirubin, Test of Cure | -0.01 micromoles per Liter (umol/L) | Standard Deviation 2.976 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Total Bilirubin, Baseline | 6.57 micromoles per Liter (umol/L) | Standard Deviation 3.94 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Creatinine, Baseline | 58.8 micromoles per Liter (umol/L) | Standard Deviation 30.59 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Direct Bilirubin, Test of Cure | -0.19 micromoles per Liter (umol/L) | Standard Deviation 1.059 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Creatinine, On-Therapy | 0.8 micromoles per Liter (umol/L) | Standard Deviation 30.31 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Total Bilirubin, On-Therapy | -0.28 micromoles per Liter (umol/L) | Standard Deviation 2.51 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Creatinine, Test of Cure | 1.7 micromoles per Liter (umol/L) | Standard Deviation 14 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Direct Bilirubin, Baseline | 4.61 micromoles per Liter (umol/L) | Standard Deviation 1.669 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Creatinine, Test of Cure | 1.5 micromoles per Liter (umol/L) | Standard Deviation 13.4 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Direct Bilirubin, Baseline | 4.47 micromoles per Liter (umol/L) | Standard Deviation 1.128 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Direct Bilirubin, On- Therapy | -0.18 micromoles per Liter (umol/L) | Standard Deviation 1.114 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Direct Bilirubin, Test of Cure | 0.15 micromoles per Liter (umol/L) | Standard Deviation 1.288 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Total Bilirubin, Baseline | 6.56 micromoles per Liter (umol/L) | Standard Deviation 3.518 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Total Bilirubin, On-Therapy | -0.42 micromoles per Liter (umol/L) | Standard Deviation 2.672 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Total Bilirubin, Test of Cure | -0.29 micromoles per Liter (umol/L) | Standard Deviation 3.23 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Creatinine, Baseline | 58.1 micromoles per Liter (umol/L) | Standard Deviation 17.22 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels | Serum Creatinine, On-Therapy | 0.3 micromoles per Liter (umol/L) | Standard Deviation 10.31 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count
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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Hematology Parameter: Erythrocytes (RBC) Count | Baseline | 4.539 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.4211 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count | On-Therapy | -0.046 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.2309 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count | Test of Cure | -0.038 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.2634 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count | Baseline | 4.539 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.4379 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count | On-Therapy | -0.060 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.2513 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count | Test of Cure | -0.049 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.3052 |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit Level
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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Hematology Parameter: Hematocrit Level | Baseline | 0.4314 Percentage of hematocrit | Standard Deviation 0.04146 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Hematocrit Level | On-Therapy | -0.0033 Percentage of hematocrit | Standard Deviation 0.02832 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Hematocrit Level | Test of Cure | -0.0045 Percentage of hematocrit | Standard Deviation 0.02806 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Hematocrit Level | Baseline | 0.4292 Percentage of hematocrit | Standard Deviation 0.04348 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Hematocrit Level | On-Therapy | -0.0041 Percentage of hematocrit | Standard Deviation 0.02715 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Hematocrit Level | Test of Cure | -0.0029 Percentage of hematocrit | Standard Deviation 0.03194 |
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin Level
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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Hematology Parameter: Hemoglobin Level | Baseline | 132.5 Gram per Liter (g/L) | Standard Deviation 13.25 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Hemoglobin Level | On-Therapy | -1.5 Gram per Liter (g/L) | Standard Deviation 6.74 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Hemoglobin Level | Test of Cure | -1.3 Gram per Liter (g/L) | Standard Deviation 7.44 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Hemoglobin Level | Baseline | 131.7 Gram per Liter (g/L) | Standard Deviation 14.28 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Hemoglobin Level | On-Therapy | -1.9 Gram per Liter (g/L) | Standard Deviation 6.82 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Hemoglobin Level | Test of Cure | -1.4 Gram per Liter (g/L) | Standard Deviation 8.33 |
Secondary
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline | 29.28 Picogram (pg) | Standard Deviation 2.537 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | On-Therapy | -0.02 Picogram (pg) | Standard Deviation 0.795 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Test of Cure | -0.04 Picogram (pg) | Standard Deviation 0.78 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline | 29.09 Picogram (pg) | Standard Deviation 2.644 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | On-Therapy | -0.02 Picogram (pg) | Standard Deviation 0.82 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Test of Cure | 0.02 Picogram (pg) | Standard Deviation 0.917 |
Secondary
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline | 95.30 Femtolitre (fL) | Standard Deviation 7.191 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | On-Therapy | 0.26 Femtolitre (fL) | Standard Deviation 4.287 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | Test of Cure | -0.15 Femtolitre (fL) | Standard Deviation 4.049 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline | 94.82 Femtolitre (fL) | Standard Deviation 7.511 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | On-Therapy | 0.35 Femtolitre (fL) | Standard Deviation 4.303 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | Test of Cure | 0.39 Femtolitre (fL) | Standard Deviation 4.73 |
Secondary
Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of hematology parameters: neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Eosinophils, Baseline | 0.161 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.135 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Eosinophils, On-Therapy | 0.006 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0841 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Eosinophils, Test of Cure | 0.015 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0906 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Basophils, Baseline | 0.054 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0227 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Basophils, On-Therapy | -0.001 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0195 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Basophils, Test of Cure | 0.000 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0209 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Lymphocytes, Baseline | 2.091 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.6954 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Lymphocytes, On-Therapy | -0.018 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.4523 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Lymphocytes, Test of Cure | -0.010 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.5292 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Monocytes, Baseline | 0.529 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1803 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Monocytes, On-Therapy | -0.020 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1487 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Monocytes, Test of Cure | -0.029 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1731 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Neutrophils, Baseline | 4.582 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.8893 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Neutrophils, On-Therapy | -0.490 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.6201 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Neutrophils, Test of Cure | -0.534 Giga cells per Liter (10^9 cells/L) | Standard Deviation 2.0207 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Platelets, Baseline | 280.3 Giga cells per Liter (10^9 cells/L) | Standard Deviation 68.46 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Platelets, On-Therapy | -1.1 Giga cells per Liter (10^9 cells/L) | Standard Deviation 33.03 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Platelets, Test of Cure | 6.8 Giga cells per Liter (10^9 cells/L) | Standard Deviation 42.12 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Neutrophils, On-Therapy | -0.453 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.7453 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Eosinophils, Baseline | 0.163 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1331 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Monocytes, Baseline | 0.525 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.179 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Eosinophils, On-Therapy | 0.013 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0814 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Platelets, Test of Cure | 5.5 Giga cells per Liter (10^9 cells/L) | Standard Deviation 58.04 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Eosinophils, Test of Cure | 0.018 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1081 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Monocytes, On-Therapy | 0.003 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1711 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Basophils, Baseline | 0.053 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0228 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Neutrophils, Test of Cure | -0.494 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.9072 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Basophils, On-Therapy | 0.001 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0194 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Monocytes, Test of Cure | -0.012 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1778 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Basophils, Test of Cure | 0.001 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0183 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Platelets, On-Therapy | -2.5 Giga cells per Liter (10^9 cells/L) | Standard Deviation 36.67 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Lymphocytes, Baseline | 2.121 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.7122 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Neutrophils, Baseline | 4.755 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.8821 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Lymphocytes, On-Therapy | -0.076 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.5051 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Platelets, Baseline | 287.2 Giga cells per Liter (10^9 cells/L) | Standard Deviation 73.51 |
| Nitrofurantoin | Change From Baseline in Hematology Parameters: Neutrophil Count, Lymphocyte Count, Monocyte Count, Eosinophil Count, Basophil Count and Platelet Count at On Therapy and Test of Cure Visit | Lymphocytes, Test of Cure | 0.059 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.5839 |
Secondary
Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit
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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Pulse Rate at On Therapy and Test of Cure Visit | Pulse rate, Baseline | 73.2 beats per minute (bpm) | Standard Deviation 9.64 |
| Gepotidacin | Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit | Pulse rate, On-Therapy | 0.9 beats per minute (bpm) | Standard Deviation 8.24 |
| Gepotidacin | Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit | Pulse rate, Test of Cure | 1.8 beats per minute (bpm) | Standard Deviation 9.74 |
| Nitrofurantoin | Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit | Pulse rate, Baseline | 73.7 beats per minute (bpm) | Standard Deviation 10.32 |
| Nitrofurantoin | Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit | Pulse rate, On-Therapy | 1.3 beats per minute (bpm) | Standard Deviation 8.66 |
| Nitrofurantoin | Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit | Pulse rate, Test of Cure | 1.7 beats per minute (bpm) | Standard Deviation 9.95 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit
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 (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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 in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | SBP, Baseline | 122 Millimeters of mercury (mmHg) | Standard Deviation 13.33 |
| Gepotidacin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | SBP, On-Therapy | -1.1 Millimeters of mercury (mmHg) | Standard Deviation 10.14 |
| Gepotidacin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | SBP, Test of Cure | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 11.67 |
| Gepotidacin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | DBP, Baseline | 76.9 Millimeters of mercury (mmHg) | Standard Deviation 8.17 |
| Gepotidacin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | DBP, On-Therapy | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 7.3 |
| Gepotidacin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | DBP, Test of Cure | -0.1 Millimeters of mercury (mmHg) | Standard Deviation 7.98 |
| Nitrofurantoin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | DBP, On-Therapy | -0.6 Millimeters of mercury (mmHg) | Standard Deviation 7.73 |
| Nitrofurantoin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | SBP, Baseline | 122.7 Millimeters of mercury (mmHg) | Standard Deviation 13.98 |
| Nitrofurantoin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | DBP, Baseline | 77 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Nitrofurantoin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | SBP, On-Therapy | -1.1 Millimeters of mercury (mmHg) | Standard Deviation 10.72 |
| Nitrofurantoin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | DBP, Test of Cure | -1.3 Millimeters of mercury (mmHg) | Standard Deviation 8.37 |
| Nitrofurantoin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | SBP, Test of Cure | -1.8 Millimeters of mercury (mmHg) | Standard Deviation 12.19 |
Secondary
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical outcomes at FU were categorized as Sustained Clinical Response (SCR), Delayed Clinical Response (DCR), CI, CW, Clinical Recurrence (CR) and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. UTD outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for current infection (uUTI) prior to assessment (unless CS or CR outcome criteria were met).
Time frame: FU visit (Days 21 to 31)
Population: Intent-to-Treat (ITT) population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Sustained Clinical Resolution (SCR) | 478 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Delayed Clinical Resolution (DCR) | 108 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical Improvement (CI) | 40 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical Worsening (CW) | 51 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical Recurrence (CR) | 25 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Unable to Determine (UTD) | 103 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical Recurrence (CR) | 28 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Sustained Clinical Resolution (SCR) | 443 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical Worsening (CW) | 65 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Delayed Clinical Resolution (DCR) | 116 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Unable to Determine (UTD) | 96 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical Improvement (CI) | 52 Participants |
Secondary
Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical outcomes at FU were categorized as SCR, DCR, CI, CW, CR and UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at the TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. Unable to determine outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for the current infection (uUTI) prior to the assessment (unless CS or CR outcome criteria were met).
Time frame: FU visit (Days 21 to 31)
Population: Micro-ITT NTF-S population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Sustained Clinical Resolution (SCR) | 168 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Delayed Clinical Resolution (DCR) | 34 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical Improvement (CI) | 15 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical Worsening (CW) | 26 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical Recurrence (CR) | 8 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Unable to Determine (UTD) | 41 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical Recurrence (CR) | 7 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Sustained Clinical Resolution (SCR) | 154 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical Worsening (CW) | 32 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Delayed Clinical Resolution (DCR) | 35 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Unable to Determine (UTD) | 28 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical Improvement (CI) | 19 Participants |
Secondary
Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution symptoms of acute cystitis present at baseline (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: TOC visit (Days 9 to 16)
Population: Intent-to-Treat (ITT) population included all participants randomly assigned to study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical Resolution | 549 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical Improvement | 153 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical Worsening | 36 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Unable to Determine | 67 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Unable to Determine | 45 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical Resolution | 517 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical Worsening | 39 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical Improvement | 199 Participants |
Secondary
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Clinical outcomes at TOC were 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 baseline (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: 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 | 199 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical Improvement (CI) | 51 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical Worsening (CW) | 20 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Unable to Determine | 22 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Unable to Determine | 15 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical Resolution | 175 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical Worsening (CW) | 17 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical Improvement (CI) | 68 Participants |
Secondary
Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population
Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
Time frame: FU visit (Days 21 to 31)
Population: Intent-to-Treat (ITT) population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical Success | 478 Participants |
| Gepotidacin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical Failure | 327 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical Success | 443 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical Failure | 357 Participants |
Secondary
Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
Time frame: FU visit (Days 21 to 31)
Population: Micro-ITT NTF-S population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical Success | 168 Participants |
| Gepotidacin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical Failure | 124 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical Success | 154 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical Failure | 121 Participants |
Secondary
Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population
Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of signs and 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.
Time frame: TOC visit (Days 9 to 16)
Population: Intent-to-Treat (ITT) population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical Success | 549 Participants |
| Gepotidacin | Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical Failure | 256 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical Success | 517 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical Failure | 283 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: 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 | 199 Participants |
| Gepotidacin | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | Clinical Failure | 93 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | Clinical Failure | 100 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | Clinical Success | 175 Participants |
Secondary
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline
Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles \<=450, \>450 to \<=480, \>480 to \<=500 millisecond (msec) are the values at baseline. The category titles \<= 30, 31-60, \>60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented.
Time frame: Up to Day 31
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | <= 450 msec | <=30 msec | 675 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | <= 450 msec | 31-60 msec | 23 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | <= 450 msec | >60 msec | 1 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | <= 450 msec | Missing | 47 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >450 to <=480 msec | <=30 msec | 40 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >450 to <=480 msec | 31-60 msec | 2 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >450 to <=480 msec | >60 msec | 0 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >450 to <=480 msec | Missing | 3 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >480 to <=500 msec | <=30 msec | 1 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >450 to <=480 msec | <=30 msec | 37 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >480 to <=500 msec | 31-60 msec | 0 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >450 to <=480 msec | 31-60 msec | 0 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >480 to <=500 msec | >60 msec | 0 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | <= 450 msec | <=30 msec | 700 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >450 to <=480 msec | >60 msec | 0 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | <= 450 msec | 31-60 msec | 12 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >480 to <=500 msec | Missing | 0 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | <= 450 msec | >60 msec | 0 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | >450 to <=480 msec | Missing | 3 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline | <= 450 msec | Missing | 31 Participants |
Secondary
Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline
Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles \<=450 msec, \>450 msec to \<=480 msec are the values at baseline. The category titles \<= 30, 31-60, \>60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented.
Time frame: Up to Day 31
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | <= 450 msec | <=30 msec | 721 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | <= 450 msec | 31-60 msec | 12 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | <= 450 msec | >60 msec | 0 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | <= 450 msec | Missing | 50 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | >450 to <=480 msec | <=30 msec | 8 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | >450 to <=480 msec | 31-60 msec | 0 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | >450 to <=480 msec | >60 msec | 0 Participants |
| Gepotidacin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | >450 to <=480 msec | Missing | 0 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | >450 to <=480 msec | Missing | 1 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | <= 450 msec | <=30 msec | 742 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | >450 to <=480 msec | <=30 msec | 4 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | <= 450 msec | 31-60 msec | 4 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | >450 to <=480 msec | >60 msec | 0 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | <= 450 msec | >60 msec | 0 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | >450 to <=480 msec | 31-60 msec | 0 Participants |
| Nitrofurantoin | Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline | <= 450 msec | Missing | 33 Participants |
Secondary
Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Participant-level MOs at FU were categorized as sustained microbiological eradication (SME), microbiological recurrence (MR), microbiological persistence (MP), delayed microbiological eradication (DME) and unable to determine (UTD). SME at FU was defined as all baseline QUPs had an outcome of sustained eradication at FU (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the FU Visit). MR at FU was defined as at least one QUP had an outcome of recurrence (≥10\^3 CFU/mL) and none had an outcome of persistence at FU. MP at FU was defined as at least one QUP had an outcome of persistence at FU. DME at FU was defined as at least one QUP had an outcome of delayed eradication and none had an outcome of persistence or recurrence at FU. UTD at FU was defined as all QUP outcomes were unable to determine at FU.
Time frame: FU visit (Days 21 to 31)
Population: Micro-ITT NTF-S population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological Persistence (MP) | 19 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Delayed Microbiological Eradication (DME) | 20 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological Recurrence (MR) | 29 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Unable to Determine (UTD) | 70 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Sustained Microbiological Eradication (SME) | 154 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Unable to Determine (UTD) | 61 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Sustained Microbiological Eradication (SME) | 119 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological Persistence (MP) | 44 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological Recurrence (MR) | 23 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Delayed Microbiological Eradication (DME) | 28 Participants |
Secondary
Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population
Participant-level MOs at TOC were 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: 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) | 213 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Microbiological Persistence (MP) | 13 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Microbiological Recurrence (MR) | 19 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Unable to Determine (UTD) | 47 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Unable to Determine (UTD) | 34 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Microbiological Eradication (ME) | 158 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Microbiological Recurrence (MR) | 52 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Microbiological Persistence (MP) | 31 Participants |
Secondary
Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population
Participant- level microbiological response at FU was categorized as microbiological success and microbiological failure. Microbiological success at FU was defined as all baseline QUPs had a microbiological outcome of sustained eradication at FU visit. Microbiological failure at FU was defined as not meeting criteria of microbiological success including those participants with UTD outcome.
Time frame: FU visit (Days 21 to 31)
Population: Micro-ITT NTF-S population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological Success | 154 Participants |
| Gepotidacin | Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological Failure | 138 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological Success | 119 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological Failure | 156 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)s 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: 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 | 213 Participants |
| Gepotidacin | Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population | Microbiological Failure | 79 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population | Microbiological Success | 158 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population | Microbiological Failure | 117 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
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.
Time frame: From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Population: Safety population included all randomized participants who receive at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gepotidacin | Number of Participants With Serious Adverse Events (SAEs) | 5 Participants |
| Nitrofurantoin | Number of Participants With Serious Adverse Events (SAEs) | 5 Participants |
Secondary
Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population
TR at FU was categorized as therapeutic success and therapeutic failure. A therapeutic success at FU referred to participants who have been deemed both a microbiological success (reduction of all QUPs recovered at BL to \<10\^3 CFU/mL, following microbiological eradication at the TOC visit, without receiving other AB before the FU visit) and a clinical success (resolution of signs and symptoms of acute cystitis demonstrated at the TOC visit persist at the FU visit and no new signs and symptoms, without receiving other AB before the FU visit \[or AB for uUTI on day of FU visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Time frame: FU visit (Days 21 to 31)
Population: Micro-ITT NTF-S population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Therapeutic Success | 126 Participants |
| Gepotidacin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Therapeutic Failure | 166 Participants |
| Nitrofurantoin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Therapeutic Success | 95 Participants |
| Nitrofurantoin | Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Therapeutic Failure | 180 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.
Time frame: From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
Population: Safety population included all randomized participants who receive at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gepotidacin | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 285 Participants |
| Nitrofurantoin | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 200 Participants |
Secondary
Number of Participants With Urinalysis Dipstick Results
Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Protein (PRO), Urine Occult Blood (BLO), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Leukocyte Esterase (LEU). 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, Trace, Small, Moderate, Large, Positive, 50 milligram per deciliter (mg/dL), 150 mg/dL, \>=500 mg/dL, 30 mg/dL, 100 mg/dL, 200 mg/dL, 5 mg/dL, 20 mg/dL, \>=80 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, Negative), GLU indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Data is presented in similar way for others parameters.
Time frame: Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (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, Test of Cure, Negative | 686 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, Test of Cure, Small | 128 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, 30 mg/dL | 110 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, Test of Cure, Moderate | 49 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, 50 mg/dL | 4 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, Test of Cure, Large | 25 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, 100 mg/dL | 43 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, Negative | 754 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Test of Cure, 50 mg/dL | 9 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, 5 mg/dL | 14 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, >=500 mg/dL | 3 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, 20 mg/dL | 11 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, Negative | 751 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, Negative | 712 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Test of Cure, Negative | 605 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, 5 mg/dL | 14 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Test of Cure, 150 mg/dL | 12 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Test of Cure, 30 mg/dL | 88 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, >=80 mg/dL | 0 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, 50 mg/dL | 7 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Test of Cure, Negative | 706 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Test of Cure, 100 mg/dL | 25 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Test of Cure, 5 mg/dL | 7 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Test of Cure, >= 500 mg/dL | 12 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, Test of Cure, 20 mg/dL | 6 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Test of Cure, >=500 mg/dL | 1 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, Baseline, Negative | 552 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, 150 mg/dL | 3 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, Baseline, Positive | 237 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Positive | 0 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, On-Therapy, Negative | 694 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Negative | 345 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, On-Therapy, Positive | 37 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, Negative | 524 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, Test of Cure, Negative | 697 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Trace | 2 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | NIT, Test of Cure, Positive | 22 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, 150 mg/dL | 1 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Negative | 245 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Small | 229 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Trace | 96 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, 30 mg/dL | 171 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Small | 75 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Moderate | 128 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Moderate | 120 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, Negative | 700 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Large | 251 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Large | 80 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Missing | 2 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, 100 mg/dL | 78 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, On-Therapy, Negative | 510 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, On-Therapy, Negative | 560 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, On-Therapy, Trace | 79 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, >= 500 mg/dL | 23 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, On-Therapy, Small | 50 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, On-Therapy, Small | 116 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, On-Therapy, Moderate | 34 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, >=500 mg/dL | 5 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, On-Therapy, Large | 58 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, On-Therapy, Moderate | 23 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, Test of Cure, Negative | 526 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, >= 500 mg/dL | 21 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, Test of Cure, Trace | 61 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, On-Therapy, Large | 32 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, Test of Cure, Small | 43 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, Negative | 575 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, Test of Cure, Moderate | 35 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | BLO, Test of Cure, Negative | 517 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | LEU, Test of Cure, Large | 54 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, 20 mg/dL | 5 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, Test of Cure, Large | 77 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, Negative | 738 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, 50 mg/dL | 5 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, 150 mg/dL | 4 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Baseline, >= 500 mg/dL | 26 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, Negative | 697 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, 50 mg/dL | 7 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, 150 mg/dL | 5 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, On-Therapy, >= 500 mg/dL | 28 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Test of Cure, Negative | 693 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Test of Cure, 50 mg/dL | 10 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Test of Cure, 150 mg/dL | 4 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | GLU, Test of Cure, >= 500 mg/dL | 20 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, Negative | 529 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, 30 mg/dL | 149 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, 100 mg/dL | 85 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Baseline, >=500 mg/dL | 6 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, Negative | 631 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, 30 mg/dL | 83 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, 100 mg/dL | 19 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, On-Therapy, >=500 mg/dL | 4 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Test of Cure, Negative | 605 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Test of Cure, 30 mg/dL | 88 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Test of Cure, 100 mg/dL | 34 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | PRO, Test of Cure, >=500 mg/dL | 0 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Negative | 348 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Trace | 0 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Small | 217 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Moderate | 129 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Large | 81 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, On-Therapy, Negative | 520 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, On-Therapy, Small | 161 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, On-Therapy, Moderate | 30 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, On-Therapy, Large | 26 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, Test of Cure, Negative | 511 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, Test of Cure, Small | 139 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, Test of Cure, Moderate | 45 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, Test of Cure, Large | 32 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, Negative | 748 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, 5 mg/dL | 18 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Baseline, 20 mg/dL | 7 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, Negative | 699 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, 5 mg/dL | 22 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, 20 mg/dL | 15 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, On-Therapy, >=80 mg/dL | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Test of Cure, Negative | 700 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Test of Cure, 5 mg/dL | 20 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | KET, Test of Cure, 20 mg/dL | 7 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, Baseline, Negative | 531 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, Baseline, Positive | 252 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, On-Therapy, Negative | 697 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, On-Therapy, Positive | 40 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, Test of Cure, Negative | 669 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | NIT, Test of Cure, Positive | 58 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Negative | 232 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Trace | 91 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Small | 80 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Moderate | 116 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Large | 262 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, Baseline, Missing | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, On-Therapy, Negative | 475 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, On-Therapy, Trace | 82 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, On-Therapy, Small | 49 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, On-Therapy, Moderate | 57 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, On-Therapy, Large | 74 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, Test of Cure, Negative | 494 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, Test of Cure, Trace | 49 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, Test of Cure, Small | 48 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | LEU, Test of Cure, Moderate | 59 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results | BLO, Baseline, Positive | 2 Participants |