Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04187144
Other study ID # 212390
Secondary ID 2020-000553-27
Status Completed
Phase Phase 3
First received
Last updated
Start date April 23, 2020
Est. completion date December 1, 2022

Study information

Verified date July 2023
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1606
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 12 Years and older
Eligibility Inclusion Criteria: - The participant is >=12 years of age at the time of signing the informed consent/assent and has a body weight >=40 kilogram (kg). - The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset <96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain. - The participant has nitrite or pyuria (greater than [>]15 white blood cell [WBC]/high-power field [HPF]) or the presence of 3 plus (+)/large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures. - The participant is female. - The participant is capable of giving signed informed consent/assent. Exclusion Criteria: - The participant resides in a nursing home or dependent care type-facility. - The participant has a body mass index >=40.0 kilogram per meter square (kg/m^2) or a body mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditions such as uncontrolled high blood pressure or uncontrolled diabetes. - The participant has a history of sensitivity to the study treatment, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates her participation. - The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications. - The participant has any of the following: 1. Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain,; Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; Or 2. Known acute porphyria. 3. Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention . - The participant has a known glucose-6 phosphate dehydrogenase deficiency. - The participant has a serious underlying disease that could be imminently life threatening, or the participant is unlikely to survive for the duration of the study period. - The participant has acute cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacterales (other than Escherichia coli) as the contributing pathogen. - The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments or preclude complete resolution of acute cystitis symptoms. - The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease (for example [e.g.], polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesico-ureteral reflux, detrusor insufficiency). - The participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract. - The participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptom onset >=96 hours before study entry, or a temperature >=101.4 degree Fahrenheit (>=38 Degrees Celsius [C]), flank pain, chills, or any other manifestations suggestive of upper UTI. - The participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance <60 milliliters per minute (mL/min) or clinically significant elevated serum creatinine as determined by the investigator). - The participant presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease). - The participant has congenital long QT syndrome or known prolongation of the QTc interval. - The participant has uncompensated heart failure. - The participant has severe left ventricular hypertrophy. - The participant has a family history of QT prolongation or sudden death. - The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months. - The participant is taking QT-prolonging drugs or drugs known to increase the risk of torsades de pointes (TdP) per the www.crediblemeds.org. "Known Risk of TdP" category at the time of her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor. - For any participant >=12 to <18 years of age, the participant has an abnormal ECG reading. - The participant has a QTc >450 msec or a QTc >480 msec for participants with bundle-branch block. - The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months. - The participant has a known ALT value >2 times upper limit of normal (ULN). - The participant has a known bilirubin value >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]). - The participant has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. - The participant has a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. - The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry.

Study Design


Intervention

Drug:
Gepotidacin
Gepotidacin will be available as tablets at a unit dose strength of 750mg. Participants will administer two 750 mg tablets, BID. Each dose will be taken with water after consumption of food.
Placebo matching nitrofurantoin
Placebo matching nitrofurantoin will be available as over-encapsulated unit-dose capsules. Participants will administer 1 capsule BID. Each dose should be taken with water after consumption of food.
Nitrofurantoin
Nitrofurantoin will be available as over-encapsulated 100 mg capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. Participants will administer one 100 mg capsule, BID. Each dose should be taken with water after consumption of food.
Placebo matching gepotidacin
Placebo matching gepotidacin will be available as unit-dose gepotidacin placebo-to-match tablet. Participants will administer two tablets, BID. Each dose should be taken with water after consumption of food.

Locations

Country Name City State
Australia GSK Investigational Site Maroubra New South Wales
Australia GSK Investigational Site Sydney New South Wales
Australia GSK Investigational Site Tarragindi Queensland
Bulgaria GSK Investigational Site Gabrovo
Bulgaria GSK Investigational Site Haskovo
Bulgaria GSK Investigational Site Kyustendil
Bulgaria GSK Investigational Site Montana
Bulgaria GSK Investigational Site Pleven
Bulgaria GSK Investigational Site Ruse
Bulgaria GSK Investigational Site Shumen
Bulgaria GSK Investigational Site Sofia
Bulgaria GSK Investigational Site Stara Zagora
Bulgaria GSK Investigational Site Targovisthe
India GSK Investigational Site Aurangabad
India GSK Investigational Site Chandrapur
India GSK Investigational Site Hyderabad
India GSK Investigational Site Mumbai
India GSK Investigational Site Nagpur
India GSK Investigational Site Nagpur
India GSK Investigational Site Nashik
India GSK Investigational Site New Delhi
India GSK Investigational Site Pune
India GSK Investigational Site Rajkot
India GSK Investigational Site Surat
Korea, Republic of GSK Investigational Site Ansan-si
Korea, Republic of GSK Investigational Site Goyang-si, Gyeonggi-do
Korea, Republic of GSK Investigational Site Hwasun-gun, Jeollanam-do
Korea, Republic of GSK Investigational Site Incheon
Korea, Republic of GSK Investigational Site Seoul
Korea, Republic of GSK Investigational Site Suwon
Poland GSK Investigational Site Katowice
Poland GSK Investigational Site Ostrowiec Swietokrzyski
Poland GSK Investigational Site Swidnik
Poland GSK Investigational Site Warszawa
United States GSK Investigational Site Apollo Beach Florida
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Bala-Cynwyd Pennsylvania
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Blackfoot Idaho
United States GSK Investigational Site Boise Idaho
United States GSK Investigational Site Bountiful Utah
United States GSK Investigational Site Boynton Beach Florida
United States GSK Investigational Site Bronx New York
United States GSK Investigational Site Brooklyn New York
United States GSK Investigational Site Butte Montana
United States GSK Investigational Site Cary North Carolina
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Clearwater Florida
United States GSK Investigational Site Coconut Creek Florida
United States GSK Investigational Site Columbus Ohio
United States GSK Investigational Site Columbus Ohio
United States GSK Investigational Site Columbus Ohio
United States GSK Investigational Site Dayton Ohio
United States GSK Investigational Site East Orange New Jersey
United States GSK Investigational Site Eugene Oregon
United States GSK Investigational Site Fall River Massachusetts
United States GSK Investigational Site Fargo North Dakota
United States GSK Investigational Site Gainesville Florida
United States GSK Investigational Site Gilbert Arizona
United States GSK Investigational Site Greenville South Carolina
United States GSK Investigational Site Hanover Maryland
United States GSK Investigational Site Hialeah Florida
United States GSK Investigational Site Homewood Alabama
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Huntsville Alabama
United States GSK Investigational Site Katy Texas
United States GSK Investigational Site La Mesa California
United States GSK Investigational Site Lake Worth Florida
United States GSK Investigational Site Lancaster South Carolina
United States GSK Investigational Site Lawrenceville New Jersey
United States GSK Investigational Site Leesburg Florida
United States GSK Investigational Site Lincoln Nebraska
United States GSK Investigational Site Meridian Idaho
United States GSK Investigational Site Mesquite Texas
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Milan Tennessee
United States GSK Investigational Site Missouri City Texas
United States GSK Investigational Site Modesto California
United States GSK Investigational Site Mount Laurel New Jersey
United States GSK Investigational Site New Tazewell Tennessee
United States GSK Investigational Site New York New York
United States GSK Investigational Site New York New York
United States GSK Investigational Site North Richland Hills Texas
United States GSK Investigational Site Northridge California
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Ormond Beach Florida
United States GSK Investigational Site Palm Springs Florida
United States GSK Investigational Site Pembroke Pines Florida
United States GSK Investigational Site Peoria Arizona
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Plano Texas
United States GSK Investigational Site Plant City Florida
United States GSK Investigational Site Richmond Virginia
United States GSK Investigational Site Richmond Virginia
United States GSK Investigational Site Sacramento California
United States GSK Investigational Site Saint George Utah
United States GSK Investigational Site Salt Lake City Utah
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site Sweetwater Florida
United States GSK Investigational Site Tampa Florida
United States GSK Investigational Site Union South Carolina
United States GSK Investigational Site Valencia California
United States GSK Investigational Site Washington District of Columbia
United States GSK Investigational Site West Palm Beach Florida
United States GSK Investigational Site Wilmington North Carolina
United States GSK Investigational Site Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  India,  Korea, Republic of,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Therapeutic Response (TR) (Combined Per Participant Clinical and Microbiological Response) at the Test-of-Cure (TOC) Visit - Micro-ITT NTF-S (IA Set) TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at Baseline [BL] to <10^3 colony forming units per milliliter [CFU/mL] without receiving other systemic antimicrobials [AB] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no symptoms without receiving other AB before the TOC visit [or AB for uUTI on day of TOC visit]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. TOC visit (Days 9 to 16)
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. TOC visit (Days 9 to 16)
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). TOC visit (Days 9 to 16)
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. TOC visit (Days 9 to 16)
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. TOC Visit (Days 9 to 16)
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. TOC visit (Days 9 to 16)
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. FU visit (Days 21 to 31)
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). FU visit (Days 21 to 31)
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. FU visit (Days 21 to 31)
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. FU visit (Days 21 to 31)
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. FU visit (Days 21 to 31)
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). TOC visit (Days 9 to 16)
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. TOC visit (Days 9 to 16)
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). FU visit (Days 21 to 31)
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. FU visit (Days 21 to 31)
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. From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
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. From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
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. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Change From Baseline in Hematology Parameter: Hemoglobin Level Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Change From Baseline in Hematology Parameter: Hematocrit Level Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Change From Baseline in Hematology Parameter: Erythrocytes (RBC) Count Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Change From Baseline in Clinical Chemistry Parameters: Serum Blood Urea Nitrogen (BUN), Glucose Non-fasting, Calcium, Chloride, Sodium, Magnesium, Phosphate, and Potassium Levels Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin and Creatinine Levels Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Levels Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Number of Participants With Urinalysis Dipstick Results Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Protein (PRO), Urine Occult Blood (BLO), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Leukocyte Esterase (LEU). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, Small, Moderate, Large, Positive, 50 milligram per deciliter (mg/dL), 150 mg/dL, >=500 mg/dL, 30 mg/dL, 100 mg/dL, 200 mg/dL, 5 mg/dL, 20 mg/dL, >=80 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, Negative), GLU indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Data is presented in similar way for others parameters. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Absolute Mean Values of Urine Specific Gravity Urine samples were collected from participants to assess urine specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Absolute Mean Values of Urine Potential of Hydrogen (pH) Urine samples were collected from participants to assess urine pH levels. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
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. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
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. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Change From Baseline in Body Temperature Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value. Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
Secondary Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter: QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Worst-case Post-baseline Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles <=450, >450 to <=480, >480 to <=500 millisecond (msec) are the values at baseline. The category titles <= 30, 31-60, >60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented. Up to Day 31
Secondary Number of Participants With Maximum Change From Baseline in Electrocardiograms (ECG) Parameter- QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) at Worst-case Post-baseline Triplicate 12-lead ECGs (over an approximate 5- to 10-minute period) were performed using an ECG machine. Baseline is defined as the latest pre-dose assessment with a non-missing value. The row titles <=450 msec, >450 msec to <=480 msec are the values at baseline. The category titles <= 30, 31-60, >60 msec are the maximum change from baseline values. The maximum change from baseline value category was determined by comparing the baseline value category to the worst-case post-baseline value category for each participant, which considered unscheduled and out of visit window assessments. Data of number of participants with any change at worst-case post-baseline (maximum grade increase post-baseline) is presented. Up to Day 31
See also
  Status Clinical Trial Phase
Recruiting NCT04495699 - Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections
Terminated NCT05254808 - EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care Phase 3
Completed NCT03680612 - Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI Phase 2
Completed NCT03282006 - Treating Pyelonephritis an Urosepsis With Pivmecillinam Phase 4
Completed NCT03526484 - The Utility of Urinalysis Prior to In-Office Procedures N/A
Completed NCT05397782 - Effects of Flourish on Recurrent Urinary Tract Infection N/A
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03687255 - Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections Phase 3
Recruiting NCT05227937 - Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
Completed NCT02864420 - Hospitalization at Home: The Acute Care Home Hospital Program for Adults N/A
Completed NCT03131609 - Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Completed NCT01333254 - A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients N/A
Terminated NCT00594594 - Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury Phase 1
Completed NCT00216853 - A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection N/A
Completed NCT00787085 - The Significance of Funguria in Hospitalized Patients N/A
Completed NCT05719753 - The Effectiveness of a Bacteriophobic Coating on Urinary Catheters N/A
Recruiting NCT05415865 - The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder Phase 3
Not yet recruiting NCT05880329 - DIagnoSing Care hOme UTI Study
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine