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 containing 750 mg gepotidacin. Each dose should be taken with water after consumption of food.
Placebo matching nitrofurantoin will be available as over-encapsulated unit-dose capsules. Each dose should be taken with water after consumption of food.
DRUGNitrofurantoin
Nitrofurantoin will be available as over-encapsulated capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. 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. 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
* Participants having \>=12 years of age at the time of signing the informed consent/assent and have a body weight \>=40 kilograms (kg). * Participants having 2 or more of the following clinical signs and symptoms of acute cystitis with onset \<96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain. * Participants having nitrite or pyuria (greater than \[\>\]15 white blood cells \[WBC\]/high power field \[HPF\] or the presence of 3 plus \[+\]/large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures. * The participant is female. * Participant is capable of giving signed informed consent/assent.
Exclusion criteria
* Participant resides in a nursing home or dependent care type-facility. * Participant has a body mass index \>=40.0 kilogram per square meter (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. * Participant has a history of sensitivity to the study treatments, 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. * Participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications. * 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 treatment. * Participant has a known glucose-6-phosphate dehydrogenase deficiency. * 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. * 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. * 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. * 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). * Participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract. * 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 Degrees Fahrenheit (F) (\>=38 Degrees Celsius \[C\]), flank pain, chills, or any other manifestations suggestive of upper UTI. * Participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance \<60 milliliter per minute \[mL/min\] or clinically significant elevated serum creatinine as determined by the investigator). * Participant presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease). * Participant has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval. * Participant has uncompensated heart failure. * Participant has severe left ventricular hypertrophy. * Participant has a family history of QT prolongation or sudden death. * Participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady-arrhythmia within the last 12 months. * 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 electrocardiogram (ECG) reading. * Participant has a QTc \>450 millisecond (msec) or a QTc \>480 msec for participants with bundle-branch block. * Participant has a documented or recent history of uncorrected hypokalemia within the past 3 months. * Participant has a known alanine aminotransferase (ALT) value \>2 times upper limit of normal (ULN). * 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 \[%\]). * Participant has a current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), including symptomatic viral hepatitis or moderate-to-severe liver insufficiency (Child Pugh class B or C). * Participant has a previous history of cholestatic jaundice or hepatic dysfunction associated with nitrofurantoin. * 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) | Therapeutic response (success/failure) is a measure of the overall efficacy response. A therapeutic success referred to participants who had been deemed both a microbiological success(reduction of all qualifying bacterial uropathogens \[greater than or equal to {\>=}10\^5 colony-forming units per milliliter {CFU/mL}\] recovered at Baseline to less than (\<)10\^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials before the TOC Visit) and a clinical success (resolution of signs and symptoms of acute cystitis present at Baseline \[and no new signs and symptoms\] without the participant receiving other systemic antimicrobials before the 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 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 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. |
| Plasma Concentration of Gepotidacin | Baseline (Day 1) 0-2 hour (h) and >2h post-dose; On-therapy (Day 2), morning (am) pre-dose, 0-6h, 6-8h, 8-10h, 10-12h post-dose, 0-2h, >2h evening (pm) post-dose; On-therapy (Day 3 to 5), 0-6h, 6-8h, 8-10h, 10-12h post-dose | Blood samples were collected for plasma concentration of gepotidacin. |
| Urine Concentration of Gepotidacin | Baseline (Day 1) 0-2 hour (h) and >2h post-dose; On-therapy (Day 2), morning (am) pre-dose, 0-6h, 6-8h, 8-10h, 10-12h post-dose, 0-2h, >2h evening (pm) post-dose; On-therapy (Day 3 to 5), 0-6h, 6-8h, 8-10h, 10-12h post-dose | Urine samples were collected from participants. |
| 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. |
| 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). |
| Change From Baseline in Hematology Parameter-hemoglobin Level 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 hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline in Hematology Parameter- Hematocrit Level 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 hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline in Hematology Parameter- Erythrocytes 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 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) 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 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) 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 MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels 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 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 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 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 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 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 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 clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| Number of Participants With Urinalysis Dipstick Results at Baseline, 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) | 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 mg/dL, 150 mg/dL, \>=500 mg/dL, 30 mg/dL, 100 mg/dL, 200 mg/dL, 5 mg/dL, 20 mg/dL and 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 manner for all other parameters. |
| Absolute Mean Values of Urine Specific Gravity at Baseline, 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) | 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) at Baseline, 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) | 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 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) | 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. |
| 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. |
| 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. |
Countries
Bulgaria, Czechia, Germany, Greece, Hungary, India, Mexico, Romania, Slovakia, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gepotidacin Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water. | 767 |
| 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. | 764 |
| Total | 1,531 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 6 |
| Overall Study | Lost to Follow-up | 8 | 2 |
| Overall Study | Participant not able to swallow the tablet | 1 | 0 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Protocol Deviation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 16 | 16 |
Baseline characteristics
| Characteristic | Gepotidacin | Nitrofurantoin | Total |
|---|---|---|---|
| Age, Customized Less than (<) 18 years | 6 Participants | 9 Participants | 15 Participants |
| Age, Customized More than (>) 50 years | 389 Participants | 386 Participants | 775 Participants |
| Age, Customized More than or equal to (>=) 18 years to 50 years | 372 Participants | 369 Participants | 741 Participants |
| Age, Customized | 49.6 Years STANDARD_DEVIATION 17.82 | 50.4 Years STANDARD_DEVIATION 18.17 | 50.0 Years STANDARD_DEVIATION 17.99 |
| Baseline Acute Cystitis Recurrence Non-Recurrent Infection | 455 Participants | 455 Participants | 910 Participants |
| Baseline Acute Cystitis Recurrence Recurrent Infection | 312 Participants | 309 Participants | 621 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 278 Participants | 270 Participants | 548 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 489 Participants | 494 Participants | 983 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 62 Participants | 75 Participants | 137 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 21 Participants | 44 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 40 Participants | 80 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 6 Participants | 18 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 627 Participants | 621 Participants | 1248 Participants |
| Sex/Gender, Customized Female | 767 Participants | 764 Participants | 1531 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 766 | 0 / 760 |
| other Total, other adverse events | 207 / 766 | 94 / 760 |
| serious Total, serious adverse events | 2 / 766 | 3 / 760 |
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)
Therapeutic response (success/failure) is a measure of the overall efficacy response. A therapeutic success referred to participants who had been deemed both a microbiological success(reduction of all qualifying bacterial uropathogens \[greater than or equal to {\>=}10\^5 colony-forming units per milliliter {CFU/mL}\] recovered at Baseline to less than (\<)10\^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials before the TOC Visit) and a clinical success (resolution of signs and symptoms of acute cystitis present at Baseline \[and no new signs and symptoms\] without the participant receiving other systemic antimicrobials before the 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 | 158 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 | 135 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 | 152 Participants |
95% CI: [-3.6, 12.1]
p-value: 0.144595% CI: [-3.6, 12.1]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 | 174 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 | 162 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 | 140 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 | 158 Participants |
Secondary
Absolute Mean Values of Urine Potential of Hydrogen (pH) at Baseline, On Therapy and Test of Cure Visit
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) at Baseline, On Therapy and Test of Cure Visit | Urine pH, Baseline | 5.6 pH | Standard Deviation 0.76 |
| Gepotidacin | Absolute Mean Values of Urine Potential of Hydrogen (pH) at Baseline, On Therapy and Test of Cure Visit | Urine pH, On-Therapy | 5.6 pH | Standard Deviation 0.68 |
| Gepotidacin | Absolute Mean Values of Urine Potential of Hydrogen (pH) at Baseline, On Therapy and Test of Cure Visit | Urine pH, Test of Cure | 5.6 pH | Standard Deviation 0.68 |
| Nitrofurantoin | Absolute Mean Values of Urine Potential of Hydrogen (pH) at Baseline, On Therapy and Test of Cure Visit | Urine pH, Baseline | 5.7 pH | Standard Deviation 0.79 |
| Nitrofurantoin | Absolute Mean Values of Urine Potential of Hydrogen (pH) at Baseline, On Therapy and Test of Cure Visit | Urine pH, On-Therapy | 5.6 pH | Standard Deviation 0.73 |
| Nitrofurantoin | Absolute Mean Values of Urine Potential of Hydrogen (pH) at Baseline, On Therapy and Test of Cure Visit | Urine pH, Test of Cure | 5.6 pH | Standard Deviation 0.7 |
Secondary
Absolute Mean Values of Urine Specific Gravity at Baseline, On Therapy and Test of Cure Visit
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 at Baseline, On Therapy and Test of Cure Visit | Urine Specific Gravity, Baseline | 1.0168 Ratio | Standard Deviation 0.00639 |
| Gepotidacin | Absolute Mean Values of Urine Specific Gravity at Baseline, On Therapy and Test of Cure Visit | Urine Specific Gravity, On-Therapy | 1.0175 Ratio | Standard Deviation 0.00663 |
| Gepotidacin | Absolute Mean Values of Urine Specific Gravity at Baseline, On Therapy and Test of Cure Visit | Urine Specific Gravity, Test of Cure | 1.0179 Ratio | Standard Deviation 0.007 |
| Nitrofurantoin | Absolute Mean Values of Urine Specific Gravity at Baseline, On Therapy and Test of Cure Visit | Urine Specific Gravity, Baseline | 1.0166 Ratio | Standard Deviation 0.00636 |
| Nitrofurantoin | Absolute Mean Values of Urine Specific Gravity at Baseline, On Therapy and Test of Cure Visit | Urine Specific Gravity, On-Therapy | 1.0166 Ratio | Standard Deviation 0.00636 |
| Nitrofurantoin | Absolute Mean Values of Urine Specific Gravity at Baseline, On Therapy and Test of Cure Visit | Urine Specific Gravity, Test of Cure | 1.0179 Ratio | Standard Deviation 0.00701 |
Secondary
Change From Baseline in Body Temperature at On Therapy and Test of Cure Visit
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 at On Therapy and Test of Cure Visit | Temperature, On-Therapy | -0.04 celsius | Standard Deviation 0.3 |
| Gepotidacin | Change From Baseline in Body Temperature at On Therapy and Test of Cure Visit | Temperature, Baseline | 36.62 celsius | Standard Deviation 0.372 |
| Gepotidacin | Change From Baseline in Body Temperature at On Therapy and Test of Cure Visit | Temperature, Test of Cure | -0.04 celsius | Standard Deviation 0.33 |
| Nitrofurantoin | Change From Baseline in Body Temperature at On Therapy and Test of Cure Visit | Temperature, Baseline | 36.62 celsius | Standard Deviation 0.406 |
| Nitrofurantoin | Change From Baseline in Body Temperature at On Therapy and Test of Cure Visit | Temperature, On-Therapy | -0.04 celsius | Standard Deviation 0.379 |
| Nitrofurantoin | Change From Baseline in Body Temperature at On Therapy and Test of Cure Visit | Temperature, Test of Cure | -0.07 celsius | Standard Deviation 0.4 |
Secondary
Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (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 at On Therapy and Test of Cure Visit | Serum Albumin, Baseline | 45.2 gram per Liter (g/L) | Standard Deviation 3.07 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Serum Albumin, On-Therapy | 0.0 gram per Liter (g/L) | Standard Deviation 2.21 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Serum Albumin, Test of Cure | -0.5 gram per Liter (g/L) | Standard Deviation 2.42 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Serum Protein, Baseline | 71.6 gram per Liter (g/L) | Standard Deviation 4.73 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Serum Protein, On-Therapy | 0.0 gram per Liter (g/L) | Standard Deviation 3.7 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Serum Protein, Test of Cure | -0.9 gram per Liter (g/L) | Standard Deviation 4.02 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Serum Protein, On-Therapy | -0.4 gram per Liter (g/L) | Standard Deviation 3.46 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Serum Albumin, Baseline | 45.4 gram per Liter (g/L) | Standard Deviation 2.91 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Serum Protein, Baseline | 71.8 gram per Liter (g/L) | Standard Deviation 4.72 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Serum Albumin, On-Therapy | -0.3 gram per Liter (g/L) | Standard Deviation 2.06 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Serum Protein, Test of Cure | -1.0 gram per Liter (g/L) | Standard Deviation 3.76 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit | Serum Albumin, Test of Cure | -0.5 gram per Liter (g/L) | Standard Deviation 2.5 |
Secondary
Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (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 at On Therapy and Test of Cure Visit | Serum ALP, Test of Cure | -1.5 Units per Liter (U/L) | Standard Deviation 9.43 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum AST, Test of Cure | 1.1 Units per Liter (U/L) | Standard Deviation 7.21 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum ALP, On-Therapy | -0.5 Units per Liter (U/L) | Standard Deviation 6.91 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum ALT, Baseline | 18.9 Units per Liter (U/L) | Standard Deviation 13.55 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum ALP, Baseline | 79.0 Units per Liter (U/L) | Standard Deviation 27.98 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum ALT, On-Therapy | 0.8 Units per Liter (U/L) | Standard Deviation 5.17 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum AST, On-Therapy | 0.5 Units per Liter (U/L) | Standard Deviation 5.97 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum ALT, Test of Cure | 1.0 Units per Liter (U/L) | Standard Deviation 8.93 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum AST, Baseline | 20.1 Units per Liter (U/L) | Standard Deviation 9.4 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum ALT, Test of Cure | 1.2 Units per Liter (U/L) | Standard Deviation 23.91 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum ALP, Baseline | 78.4 Units per Liter (U/L) | Standard Deviation 30.89 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum ALP, On-Therapy | 0.1 Units per Liter (U/L) | Standard Deviation 7.24 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum ALP, Test of Cure | 0.0 Units per Liter (U/L) | Standard Deviation 12.65 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum AST, Baseline | 21.5 Units per Liter (U/L) | Standard Deviation 16.55 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum AST, On-Therapy | 0.1 Units per Liter (U/L) | Standard Deviation 5.33 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum AST, Test of Cure | 1.6 Units per Liter (U/L) | Standard Deviation 38.77 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum ALT, Baseline | 20.0 Units per Liter (U/L) | Standard Deviation 17.84 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels at On Therapy and Test of Cure Visit | Serum ALT, On-Therapy | 0.2 Units per Liter (U/L) | Standard Deviation 5.43 |
Secondary
Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value
Time frame: Baseline (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 Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Glucose, Baseline | 5.778 millimoles per liter (mmol/L) | Standard Deviation 2.3665 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Calcium, On-Therapy | -0.009 millimoles per liter (mmol/L) | Standard Deviation 0.0914 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Calcium, Test of Cure | -0.016 millimoles per liter (mmol/L) | Standard Deviation 0.0981 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Chloride, Baseline | 101.6 millimoles per liter (mmol/L) | Standard Deviation 3.23 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Chloride, On-Therapy | 0.2 millimoles per liter (mmol/L) | Standard Deviation 2.59 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Chloride, Test of Cure | 0.4 millimoles per liter (mmol/L) | Standard Deviation 2.88 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Calcium, Baseline | 2.357 millimoles per liter (mmol/L) | Standard Deviation 0.1118 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Glucose, On-Therapy | 0.199 millimoles per liter (mmol/L) | Standard Deviation 1.4728 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Glucose, Test of Cure | 0.156 millimoles per liter (mmol/L) | Standard Deviation 1.5893 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Magnesium, Baseline | 0.836 millimoles per liter (mmol/L) | Standard Deviation 0.076 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Magnesium, On-Therapy | -0.006 millimoles per liter (mmol/L) | Standard Deviation 0.0634 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Magnesium, Test of Cure | -0.008 millimoles per liter (mmol/L) | Standard Deviation 0.0626 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Phosphate, Baseline | 1.138 millimoles per liter (mmol/L) | Standard Deviation 0.1641 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Phosphate, On-Therapy | 0.005 millimoles per liter (mmol/L) | Standard Deviation 0.1642 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Phosphate, Test of Cure | 0.009 millimoles per liter (mmol/L) | Standard Deviation 0.1857 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Potassium, Baseline | 4.32 millimoles per liter (mmol/L) | Standard Deviation 0.441 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Potassium, On-Therapy | 0.00 millimoles per liter (mmol/L) | Standard Deviation 0.443 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Potassium, Test of Cure | 0.00 millimoles per liter (mmol/L) | Standard Deviation 0.488 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Sodium, Baseline | 139.5 millimoles per liter (mmol/L) | Standard Deviation 2.69 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Sodium, On-Therapy | -0.1 millimoles per liter (mmol/L) | Standard Deviation 2.41 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Sodium, Test of Cure | 0.0 millimoles per liter (mmol/L) | Standard Deviation 2.68 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Urea Nitrogen, Baseline | 4.855 millimoles per liter (mmol/L) | Standard Deviation 1.8877 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Urea Nitrogen, On-Therapy | -0.039 millimoles per liter (mmol/L) | Standard Deviation 1.1285 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Urea Nitrogen, Test of Cure | 0.031 millimoles per liter (mmol/L) | Standard Deviation 1.3613 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Urea Nitrogen, On-Therapy | -0.045 millimoles per liter (mmol/L) | Standard Deviation 1.1848 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Calcium, Baseline | 2.374 millimoles per liter (mmol/L) | Standard Deviation 0.1154 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Phosphate, Baseline | 1.133 millimoles per liter (mmol/L) | Standard Deviation 0.175 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Calcium, On-Therapy | -0.012 millimoles per liter (mmol/L) | Standard Deviation 0.992 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Sodium, Baseline | 139.2 millimoles per liter (mmol/L) | Standard Deviation 2.64 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Calcium, Test of Cure | -0.016 millimoles per liter (mmol/L) | Standard Deviation 0.1017 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Phosphate, On-Therapy | -0.012 millimoles per liter (mmol/L) | Standard Deviation 0.1826 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Chloride, Baseline | 101.3 millimoles per liter (mmol/L) | Standard Deviation 3.08 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Urea Nitrogen, Baseline | 4.912 millimoles per liter (mmol/L) | Standard Deviation 2.1175 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Chloride, On-Therapy | 0.0 millimoles per liter (mmol/L) | Standard Deviation 2.49 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Phosphate, Test of Cure | 0.008 millimoles per liter (mmol/L) | Standard Deviation 0.1908 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Chloride, Test of Cure | 0.2 millimoles per liter (mmol/L) | Standard Deviation 2.67 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Sodium, On-Therapy | -0.2 millimoles per liter (mmol/L) | Standard Deviation 2.54 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Glucose, Baseline | 5.689 millimoles per liter (mmol/L) | Standard Deviation 1.9348 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Potassium, Baseline | 4.33 millimoles per liter (mmol/L) | Standard Deviation 0.447 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Glucose, On-Therapy | 0.397 millimoles per liter (mmol/L) | Standard Deviation 1.5986 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Urea Nitrogen, Test of Cure | 0.054 millimoles per liter (mmol/L) | Standard Deviation 1.5544 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Glucose, Test of Cure | 0.290 millimoles per liter (mmol/L) | Standard Deviation 1.5996 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Potassium, On-Therapy | -0.01 millimoles per liter (mmol/L) | Standard Deviation 0.495 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Magnesium, Baseline | 0.831 millimoles per liter (mmol/L) | Standard Deviation 0.0781 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Sodium, Test of Cure | -0.1 millimoles per liter (mmol/L) | Standard Deviation 2.64 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Magnesium, On-Therapy | -0.015 millimoles per liter (mmol/L) | Standard Deviation 0.0604 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Potassium, Test of Cure | 0.01 millimoles per liter (mmol/L) | Standard Deviation 0.495 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Serum Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels at On Therapy and Test of Cure Visit | Serum Magnesium, Test of Cure | -0.014 millimoles per liter (mmol/L) | Standard Deviation 0.0616 |
Secondary
Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (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 at On Therapy and Test of Cure Visit | Serum total bilirubin, On-Therapy | -0.10 micromoles per Liter (umol/L) | Standard Deviation 2.718 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum direct bilirubin, Baseline | 4.71 micromoles per Liter (umol/L) | Standard Deviation 1.534 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum direct bilirubin, On-Therapy | -0.26 micromoles per Liter (umol/L) | Standard Deviation 1.443 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum direct bilirubin, Test of cure | -0.24 micromoles per Liter (umol/L) | Standard Deviation 1.577 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum Creatinine, Baseline | 59.5 micromoles per Liter (umol/L) | Standard Deviation 20.67 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum Creatinine, On-Therapy | 2.8 micromoles per Liter (umol/L) | Standard Deviation 13.51 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum Creatinine, Test of Cure | 0.9 micromoles per Liter (umol/L) | Standard Deviation 16.98 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum total bilirubin, Baseline | 6.72 micromoles per Liter (umol/L) | Standard Deviation 3.914 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum total bilirubin, Test of Cure | -0.15 micromoles per Liter (umol/L) | Standard Deviation 2.904 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum total bilirubin, Baseline | 6.77 micromoles per Liter (umol/L) | Standard Deviation 3.909 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum Creatinine, On-Therapy | 2.3 micromoles per Liter (umol/L) | Standard Deviation 23.79 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum direct bilirubin, Baseline | 4.78 micromoles per Liter (umol/L) | Standard Deviation 1.462 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum total bilirubin, On-Therapy | -0.15 micromoles per Liter (umol/L) | Standard Deviation 2.655 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum direct bilirubin, On-Therapy | -0.16 micromoles per Liter (umol/L) | Standard Deviation 1.276 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum Creatinine, Test of Cure | 2.2 micromoles per Liter (umol/L) | Standard Deviation 29.46 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum direct bilirubin, Test of cure | -0.08 micromoles per Liter (umol/L) | Standard Deviation 1.534 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum total bilirubin, Test of Cure | -0.16 micromoles per Liter (umol/L) | Standard Deviation 3.107 |
| Nitrofurantoin | Change From Baseline in Clinical Chemistry Parameters - Total Bilirubin, Direct Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit | Serum Creatinine, Baseline | 59.3 micromoles per Liter (umol/L) | Standard Deviation 20.17 |
Secondary
Change From Baseline in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (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 Count at On Therapy and Test of Cure Visit | Erythrocytes, Baseline | 4.538 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.4315 |
| Gepotidacin | Change From Baseline in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | Erythrocytes, On-Therapy | -0.005 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.19 |
| Gepotidacin | Change From Baseline in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | Erythrocytes, Test of Cure | -0.033 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.2377 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | Erythrocytes, Baseline | 4.515 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.4324 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | Erythrocytes, On-Therapy | -0.011 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.2247 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit | Erythrocytes, Test of Cure | -0.048 Tera cells per Liter (10^12 cells/L) | Standard Deviation 0.2528 |
Secondary
Change From Baseline in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (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 at On Therapy and Test of Cure Visit | Hematocrit, Baseline | 0.4302 Percentage of hematocrit | Standard Deviation 0.04292 |
| Gepotidacin | Change From Baseline in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | Hematocrit, On-Therapy | 0.0003 Percentage of hematocrit | Standard Deviation 0.02238 |
| Gepotidacin | Change From Baseline in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | Hematocrit, Test of Cure | -0.0023 Percentage of hematocrit | Standard Deviation 0.02689 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | Hematocrit, Baseline | 0.4282 Percentage of hematocrit | Standard Deviation 0.4584 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | Hematocrit, On-Therapy | -0.0007 Percentage of hematocrit | Standard Deviation 0.02431 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit | Hematocrit, Test of Cure | -0.0055 Percentage of hematocrit | Standard Deviation 0.02757 |
Secondary
Change From Baseline in Hematology Parameter-hemoglobin Level at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (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 at On Therapy and Test of Cure Visit | Hemoglobin, Baseline | 132.2 Gram per Liter (g/L) | Standard Deviation 13.13 |
| Gepotidacin | Change From Baseline in Hematology Parameter-hemoglobin Level at On Therapy and Test of Cure Visit | Hemoglobin, On-Therapy | -0.1 Gram per Liter (g/L) | Standard Deviation 5.27 |
| Gepotidacin | Change From Baseline in Hematology Parameter-hemoglobin Level at On Therapy and Test of Cure Visit | Hemoglobin, Test of Cure | -0.9 Gram per Liter (g/L) | Standard Deviation 6.63 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter-hemoglobin Level at On Therapy and Test of Cure Visit | Hemoglobin, Baseline | 131.7 Gram per Liter (g/L) | Standard Deviation 14.33 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter-hemoglobin Level at On Therapy and Test of Cure Visit | Hemoglobin, On-Therapy | -0.4 Gram per Liter (g/L) | Standard Deviation 6.39 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter-hemoglobin Level at On Therapy and Test of Cure Visit | Hemoglobin, Test of Cure | -1.6 Gram per Liter (g/L) | Standard Deviation 7.27 |
Secondary
Change From Baseline in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (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) at On Therapy and Test of Cure Visit | MCH, Baseline | 29.20 Picogram (pg) | Standard Deviation 2.392 |
| Gepotidacin | Change From Baseline in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | MCH, On-Therapy | 0.02 Picogram (pg) | Standard Deviation 0.5 |
| Gepotidacin | Change From Baseline in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | MCH, Test of Cure | 0.02 Picogram (pg) | Standard Deviation 0.596 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | MCH, Baseline | 29.24 Picogram (pg) | Standard Deviation 2.499 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | MCH, On-Therapy | -0.03 Picogram (pg) | Standard Deviation 0.536 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit | MCH, Test of Cure | -0.05 Picogram (pg) | Standard Deviation 0.644 |
Secondary
Change From Baseline in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (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) at On Therapy and Test of Cure Visit | MCV, Baseline | 95.02 Femtoliter (fL) | Standard Deviation 7.057 |
| Gepotidacin | Change From Baseline in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | MCV, On-Therapy | 0.17 Femtoliter (fL) | Standard Deviation 3.269 |
| Gepotidacin | Change From Baseline in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | MCV, Test of Cure | 0.17 Femtoliter (fL) | Standard Deviation 3.511 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | MCV, Baseline | 95.03 Femtoliter (fL) | Standard Deviation 7.438 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | MCV, On-Therapy | 0.07 Femtoliter (fL) | Standard Deviation 3.248 |
| Nitrofurantoin | Change From Baseline in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit | MCV, Test of Cure | -0.019 Femtoliter (fL) | Standard Deviation 3.689 |
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 | Basophils, Baseline | 0.053 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.217 |
| 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 0.187 |
| 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 | 0.002 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0204 |
| 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 | 0.152 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1137 |
| 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 | 0.013 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.068 |
| 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 | 0.024 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.077 |
| 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 | 2.074 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.6603 |
| 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 | 0.009 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.4233 |
| 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 | -0.003 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.5106 |
| 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 | 0.528 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1808 |
| 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 | -0.022 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1445 |
| 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 | -0.022 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1528 |
| 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 | 4.715 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.9781 |
| 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 | -0.540 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.5771 |
| 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 | -0.703 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.7653 |
| 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 | 278.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 70.32 |
| 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 | 2.4 Giga cells per Liter (10^9 cells/L) | Standard Deviation 24.46 |
| 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, Test of Cure | 3.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 39.74 |
| 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 | -0.519 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.4975 |
| 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 | 0.055 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0256 |
| 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 | 0.529 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1906 |
| 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 | 0.000 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0204 |
| 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 | 8.6 Giga cells per Liter (10^9 cells/L) | Standard Deviation 47.92 |
| 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 0.0244 |
| 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 | -0.018 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.14 |
| 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 | 0.154 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1338 |
| 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 | -0.470 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.7541 |
| 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 | 0.017 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0691 |
| 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 | -0.010 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1678 |
| 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 | 0.022 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0865 |
| 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 | 2.6 Giga cells per Liter (10^9 cells/L) | Standard Deviation 29.94 |
| 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 | 2.133 Giga cells per Liter (10^9 cells/L) | Standard Deviation 2.0797 |
| 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 | 4.640 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.8018 |
| 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 | -0.026 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.5333 |
| 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 | 279.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 73.76 |
| 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 | 0.067 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.6268 |
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 | 73.5 beats per minute (bpm) | Standard Deviation 9.84 |
| Gepotidacin | Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit | Pulse rate, On-Therapy | 1.4 beats per minute (bpm) | Standard Deviation 8.39 |
| Gepotidacin | Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit | Pulse rate, Test of Cure | 1.2 beats per minute (bpm) | Standard Deviation 9.63 |
| Nitrofurantoin | Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit | Pulse rate, Baseline | 73.3 beats per minute (bpm) | Standard Deviation 9.91 |
| Nitrofurantoin | Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit | Pulse rate, On-Therapy | 1.7 beats per minute (bpm) | Standard Deviation 8.8 |
| Nitrofurantoin | Change From Baseline in Pulse Rate at On Therapy and Test of Cure Visit | Pulse rate, Test of Cure | 1.0 beats per minute (bpm) | Standard Deviation 10.18 |
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 | 123.1 Millimeters of mercury (mmHg) | Standard Deviation 13.23 |
| 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 | -0.8 Millimeters of mercury (mmHg) | Standard Deviation 9.2 |
| 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 | -0.9 Millimeters of mercury (mmHg) | Standard Deviation 10.44 |
| Gepotidacin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | DBP, Baseline | 76.5 Millimeters of mercury (mmHg) | Standard Deviation 8.36 |
| 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 | -0.2 Millimeters of mercury (mmHg) | Standard Deviation 7.48 |
| 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 | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 7.8 |
| 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 | -0.7 Millimeters of mercury (mmHg) | Standard Deviation 7.33 |
| Nitrofurantoin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | SBP, Baseline | 123.4 Millimeters of mercury (mmHg) | Standard Deviation 12.61 |
| Nitrofurantoin | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at On-Therapy and Test of Cure Visit | DBP, Baseline | 76.7 Millimeters of mercury (mmHg) | Standard Deviation 8.25 |
| 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 | -1.4 Millimeters of mercury (mmHg) | Standard Deviation 9.64 |
| 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 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 8.28 |
| 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 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 10.86 |
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) | 421 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Delayed clinical resolution (DCR) | 130 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical improvement (CI) | 75 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical worsening (CW) | 29 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) | 87 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical recurrence (CR) | 30 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Sustained clinical resolution (SCR) | 404 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical worsening (CW) | 48 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Delayed clinical resolution (DCR) | 127 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Unable to determine (UTD) | 84 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical improvement (CI) | 71 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 | Delayed clinical resolution (DCR) | 61 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Sustained clinical resolution (SCR) | 184 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical recurrence (CR) | 11 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical improvement (CI) | 28 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Unable to determine (UTD) | 40 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical worsening (CW) | 12 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Unable to determine (UTD) | 31 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Sustained clinical resolution (SCR) | 162 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Delayed clinical resolution (DCR) | 44 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical improvement (CI) | 27 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical worsening (CW) | 23 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical recurrence (CR) | 11 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 | 497 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical improvement | 194 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical worsening | 26 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Unable to determine | 50 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Unable to determine | 37 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical resolution | 484 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical worsening | 37 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical improvement | 206 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 | 224 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical improvement (CI) | 82 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical worsening (CW) | 9 Participants |
| Gepotidacin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Unable to determine | 21 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Unable to determine | 11 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical resolution | 196 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical worsening (CW) | 16 Participants |
| Nitrofurantoin | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | Clinical improvement (CI) | 75 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 | 421 Participants |
| Gepotidacin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical failure | 346 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical success | 404 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Intent-to-Treat (ITT) Population | Clinical failure | 360 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 | 184 Participants |
| Gepotidacin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical failure | 152 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical success | 162 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Clinical failure | 136 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 | 497 Participants |
| Gepotidacin | Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical failure | 270 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical success | 484 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit - Intent-to-Treat (ITT) Population | Clinical failure | 280 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 | 224 Participants |
| Gepotidacin | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | Clinical failure | 112 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | Clinical success | 196 Participants |
| Nitrofurantoin | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | Clinical failure | 102 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) | 32 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Delayed microbiological eradication (DME) | 34 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological recurrence (MR) | 36 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Unable to determine (UTD) | 60 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Sustained microbiological eradication (SME) | 174 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Unable to determine (UTD) | 58 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Sustained microbiological eradication (SME) | 136 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological persistence (MP) | 38 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological recurrence (MR) | 35 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Delayed microbiological eradication (DME) | 31 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) | 244 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Microbiological Persistence (MP) | 15 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Microbiological Recurrence (MR) | 36 Participants |
| Gepotidacin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Unable to determine (UTD) | 41 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Unable to determine (UTD) | 26 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Outcome (MO) at the TOC Visit - Micro-ITT NTF-S Population | Microbiological Eradication (ME) | 199 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) | 21 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 | 174 Participants |
| Gepotidacin | Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological Failure | 162 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological Success | 136 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the Follow up (FU) Visit - Micro-ITT NTF-S Population | Microbiological Failure | 162 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 | 244 Participants |
| Gepotidacin | Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population | Microbiological failure | 92 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population | Microbiological success | 199 Participants |
| Nitrofurantoin | Number of Participants With Microbiological Response at the TOC Visit - Micro-ITT NTF-S Population | Microbiological failure | 99 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) | 2 Participants |
| Nitrofurantoin | Number of Participants With Serious Adverse Events (SAEs) | 3 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 | 117 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 | 219 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 | 94 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 | 204 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) | 266 Participants |
| Nitrofurantoin | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 165 Participants |
Secondary
Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit
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 mg/dL, 150 mg/dL, \>=500 mg/dL, 30 mg/dL, 100 mg/dL, 200 mg/dL, 5 mg/dL, 20 mg/dL and 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 manner for all other 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 at Baseline, On Therapy and Test of Cure Visit | BLO, Test of Cure, Moderate | 46 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, On-Therapy, 100 mg/dL | 40 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Test of Cure, Large | 28 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Baseline, 150 mg/dL | 4 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Baseline, Negative | 724 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, On-Therapy, >=500 mg/dL | 2 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Baseline, 5 mg/dL | 14 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Test of Cure, 150 mg/dL | 2 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Baseline, 20 mg/dL | 4 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Test of Cure, Negative | 602 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Baseline, >=80 mg/dL | 1 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, On-Therapy, 50 mg/dL | 11 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, On-Therapy, Negative | 704 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Test of Cure, 30 mg/dL | 77 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, On-Therapy, 5 mg/dL | 10 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Test of Cure, >= 500 mg/dL | 21 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, On-Therapy, 20 mg/dL | 6 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Test of Cure, 100 mg/dL | 21 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, On-Therapy, >=80 mg/dL | 1 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Baseline, 50 mg/dL | 15 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Test of Cure, Negative | 683 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Test of Cure, >=500 mg/dL | 1 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Test of Cure, 5 mg/dL | 13 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Baseline, Negative | 501 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Test of Cure, >=80 mg/dL | 5 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Baseline, Negative | 310 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, Baseline, Negative | 466 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, On-Therapy, 150 mg/dL | 7 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, Baseline, Positive | 286 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Baseline, Positive | 2 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, On-Therapy, Negative | 655 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Baseline, 30 mg/dL | 179 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, On-Therapy, Positive | 66 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Baseline, Small | 248 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, Test of Cure, Negative | 662 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Baseline, >= 500 mg/dL | 21 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, Test of Cure, Positive | 39 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Baseline, Moderate | 118 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Negative | 186 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Baseline, 100 mg/dL | 60 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Trace | 80 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Baseline, Large | 72 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Small | 89 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, On-Therapy, >= 500 mg/dL | 22 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Moderate | 109 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, On-Therapy, Negative | 531 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Large | 292 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Baseline, >=500 mg/dL | 3 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Positive | 0 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, On-Therapy, Small | 123 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, On-Therapy, Negative | 429 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Baseline, Negative | 703 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, On-Therapy, Trace | 82 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, On-Therapy, Moderate | 38 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, On-Therapy, Small | 48 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, On-Therapy, Negative | 546 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, On-Therapy, Moderate | 57 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, On-Therapy, Large | 29 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, On-Therapy, Large | 105 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Test of Cure, Negative | 672 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Test of Cure, Negative | 506 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Test of Cure, Negative | 503 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Test of Cure, Trace | 60 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, On-Therapy, 30 mg/dL | 133 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Test of Cure, Small | 38 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Test of Cure, Small | 124 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Test of Cure, Moderate | 38 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, On-Therapy, Negative | 681 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Test of Cure, Large | 59 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Test of Cure, 50 mg/dL | 6 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Test of Cure, Large | 81 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Baseline, Negative | 717 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Baseline, 50 mg/dL | 5 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Baseline, 150 mg/dL | 3 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Baseline, >= 500 mg/dL | 15 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, On-Therapy, Negative | 680 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, On-Therapy, 50 mg/dL | 6 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, On-Therapy, 150 mg/dL | 4 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, On-Therapy, >= 500 mg/dL | 21 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Test of Cure, Negative | 672 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Test of Cure, 50 mg/dL | 4 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Test of Cure, 150 mg/dL | 4 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | GLU, Test of Cure, >= 500 mg/dL | 20 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Baseline, Negative | 501 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Baseline, 30 mg/dL | 160 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Baseline, 100 mg/dL | 72 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Baseline, >=500 mg/dL | 6 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, On-Therapy, Negative | 587 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, On-Therapy, 30 mg/dL | 102 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, On-Therapy, 100 mg/dL | 20 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, On-Therapy, >=500 mg/dL | 2 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Test of Cure, Negative | 591 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Test of Cure, 30 mg/dL | 89 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Test of Cure, 100 mg/dL | 15 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | PRO, Test of Cure, >=500 mg/dL | 5 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Baseline, Negative | 297 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Baseline, Positive | 0 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Baseline, Small | 266 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Baseline, Moderate | 107 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Baseline, Large | 75 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, On-Therapy, Negative | 475 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, On-Therapy, Small | 167 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, On-Therapy, Moderate | 40 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, On-Therapy, Large | 29 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Test of Cure, Negative | 510 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Test of Cure, Small | 114 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Test of Cure, Moderate | 50 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | BLO, Test of Cure, Large | 26 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Baseline, Negative | 726 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Baseline, 5 mg/dL | 8 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Baseline, 20 mg/dL | 5 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Baseline, >=80 mg/dL | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, On-Therapy, Negative | 688 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, On-Therapy, 5 mg/dL | 20 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, On-Therapy, 20 mg/dL | 2 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, On-Therapy, >=80 mg/dL | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Test of Cure, Negative | 688 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Test of Cure, 5 mg/dL | 11 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | KET, Test of Cure, >=80 mg/dL | 1 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, Baseline, Negative | 458 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, Baseline, Positive | 291 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, On-Therapy, Negative | 647 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, On-Therapy, Positive | 64 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, Test of Cure, Negative | 639 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | NIT, Test of Cure, Positive | 61 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Negative | 169 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Trace | 77 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Small | 74 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Moderate | 116 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Large | 314 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Baseline, Positive | 2 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, On-Therapy, Negative | 387 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, On-Therapy, Trace | 86 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, On-Therapy, Small | 69 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, On-Therapy, Moderate | 63 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, On-Therapy, Large | 106 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Test of Cure, Negative | 442 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Test of Cure, Trace | 73 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Test of Cure, Small | 54 Participants |
| Nitrofurantoin | Number of Participants With Urinalysis Dipstick Results at Baseline, On Therapy and Test of Cure Visit | LEU, Test of Cure, Moderate | 50 Participants |
Secondary
Plasma Concentration of Gepotidacin
Blood samples were collected for plasma concentration of gepotidacin.
Time frame: Baseline (Day 1) 0-2 hour (h) and >2h post-dose; On-therapy (Day 2), morning (am) pre-dose, 0-6h, 6-8h, 8-10h, 10-12h post-dose, 0-2h, >2h evening (pm) post-dose; On-therapy (Day 3 to 5), 0-6h, 6-8h, 8-10h, 10-12h post-dose
Population: Pharmacokinetic (PK) Population included all randomized participants who received at least 1 dose of study treatment and had at least 1 nonmissing plasma or urine PK concentration. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Plasma Concentration of Gepotidacin | Baseline Day 1, 0-2hour (h) post-dose | 8.52 Microgram/millilitre (ug/mL) | Standard Deviation 84.21 |
| Gepotidacin | Plasma Concentration of Gepotidacin | Baseline Day 1, >2h post-dose | 2.96 Microgram/millilitre (ug/mL) | Standard Deviation 1.865 |
| Gepotidacin | Plasma Concentration of Gepotidacin | On-Therapy Day 2, am, pre-dose | 3.48 Microgram/millilitre (ug/mL) | Standard Deviation 21.58 |
| Gepotidacin | Plasma Concentration of Gepotidacin | On-Therapy Day 2, 0-6h, am, post-dose | 4.20 Microgram/millilitre (ug/mL) | Standard Deviation 4.21 |
| Gepotidacin | Plasma Concentration of Gepotidacin | On-Therapy Day 2, 6-8h, am, post-dose | 1.22 Microgram/millilitre (ug/mL) | Standard Deviation 0.4729 |
| Gepotidacin | Plasma Concentration of Gepotidacin | On-Therapy Day 2, 8-10h, am, post-dose | 1.10 Microgram/millilitre (ug/mL) | Standard Deviation 1.103 |
| Gepotidacin | Plasma Concentration of Gepotidacin | On-Therapy Day 2, 10-12h, am, post-dose | 1.26 Microgram/millilitre (ug/mL) | Standard Deviation 1.358 |
| Gepotidacin | Plasma Concentration of Gepotidacin | On-Therapy Day 2, 0-2h, pm post-dose | 2.56 Microgram/millilitre (ug/mL) | Standard Deviation 2.717 |
| Gepotidacin | Plasma Concentration of Gepotidacin | On-Therapy Day 2, >2h, pm, post-dose | 2.61 Microgram/millilitre (ug/mL) | Standard Deviation 2.579 |
| Gepotidacin | Plasma Concentration of Gepotidacin | On-Therapy Day 3 to 5, 0-6h post-dose | 4.10 Microgram/millilitre (ug/mL) | Standard Deviation 3.955 |
| Gepotidacin | Plasma Concentration of Gepotidacin | On-Therapy Day 3 to 5, 6-8h post-dose | 2.54 Microgram/millilitre (ug/mL) | Standard Deviation 3.006 |
| Gepotidacin | Plasma Concentration of Gepotidacin | On-Therapy Day 3 to 5, 8-10h post-dose | 1.08 Microgram/millilitre (ug/mL) | Standard Deviation 0.9247 |
| Gepotidacin | Plasma Concentration of Gepotidacin | On-Therapy Day 3 to 5, 10-12h post-dose | 1.17 Microgram/millilitre (ug/mL) | Standard Deviation 1.688 |
Secondary
Urine Concentration of Gepotidacin
Urine samples were collected from participants.
Time frame: Baseline (Day 1) 0-2 hour (h) and >2h post-dose; On-therapy (Day 2), morning (am) pre-dose, 0-6h, 6-8h, 8-10h, 10-12h post-dose, 0-2h, >2h evening (pm) post-dose; On-therapy (Day 3 to 5), 0-6h, 6-8h, 8-10h, 10-12h post-dose
Population: Pharmacokinetic (PK) Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Urine Concentration of Gepotidacin | Baseline Day 1, 0-2hour (h) post-dose | 317 ug/mL | Standard Deviation 680.3 |
| Gepotidacin | Urine Concentration of Gepotidacin | Baseline Day 1, >2h post-dose | 857 ug/mL | Standard Deviation 1539 |
| Gepotidacin | Urine Concentration of Gepotidacin | On-Therapy Day 2, am, pre-dose | 391 ug/mL | Standard Deviation 402.5 |
| Gepotidacin | Urine Concentration of Gepotidacin | On-Therapy Day 2, 0-6h, am, post-dose | 781 ug/mL | Standard Deviation 1449 |
| Gepotidacin | Urine Concentration of Gepotidacin | On-Therapy Day 2, 6-8h, am, post-dose | 363 ug/mL | Standard Deviation 443.7 |
| Gepotidacin | Urine Concentration of Gepotidacin | On-Therapy Day 2, 8-10h, am, post-dose | 326 ug/mL | Standard Deviation 274.4 |
| Gepotidacin | Urine Concentration of Gepotidacin | On-Therapy Day 2, 10-12h, am, post-dose | 287 ug/mL | Standard Deviation 423.2 |
| Gepotidacin | Urine Concentration of Gepotidacin | On-Therapy Day 2, 0-2h, pm post-dose | 156 ug/mL | Standard Deviation 216.1 |
| Gepotidacin | Urine Concentration of Gepotidacin | On-Therapy Day 2, >2h, pm, post-dose | 624 ug/mL | — |
| Gepotidacin | Urine Concentration of Gepotidacin | On-Therapy Day 3 to 5, 0-6h post-dose | 651 ug/mL | Standard Deviation 1313 |
| Gepotidacin | Urine Concentration of Gepotidacin | On-Therapy Day 3 to 5, 6-8h post-dose | 259 ug/mL | Standard Deviation 164.9 |
| Gepotidacin | Urine Concentration of Gepotidacin | On-Therapy Day 3 to 5, 8-10h post-dose | 522 ug/mL | Standard Deviation 663.1 |
| Gepotidacin | Urine Concentration of Gepotidacin | On-Therapy Day 3 to 5, 10-12h post-dose | 370 ug/mL | Standard Deviation 498.8 |