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Trial record 1 of 1 for:    NCT04187144
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Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04187144
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
Urinary tract infections (UTIs; acute cystitis) are very common, with approximately 11 percentage of women (>18 years of age) reporting at least 1 episode of acute cystitis per year. The purpose of this study to evaluate the therapeutic response (combined microbiological and clinical efficacy per participant) of oral gepotidacin compared to oral nitrofurantoin for acute cystitis in adolescent and adult female participants. In this study, participants will be randomly assigned in a 1:1 ratio to receive either oral gepotidacin or oral nitrofurantoin. The study will enroll approximately 1200 participants with uncomplicated UTI. The duration of the study will be approximately 28 days with 4 planned study visits.

Condition or disease Intervention/treatment Phase
Infections, Bacterial Drug: Gepotidacin Drug: Placebo matching nitrofurantoin Drug: Nitrofurantoin Drug: Placebo matching gepotidacin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a parallel study, wherein the participants will be randomized in a 1:1 ratio to receive either gepotidacin 1500 milligram (mg) or nitrofurantoin 100 mg, orally twice daily (BID) for 5 days after food consumption and with water.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double blinded study wherein participants and study personnel will be blinded to the allocated intervention.
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gepotidacin
Participants will be administered oral doses of 1500 mg gepotidacin plus nitrofurantoin matching placebo BID; approximately every 12 hours for 5 days
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.

Drug: 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.

Active Comparator: Nitrofurantoin
Participants will be administered oral doses of 100 mg nitrofurantoin plus gepotidacin matching placebo BID; approximately every 12 hours for 5 days.
Drug: 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.

Drug: 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.




Primary Outcome Measures :
  1. Number of participants with therapeutic response at the Test-of-Cure (TOC) visit [ Time Frame: Up to Day 13 ]
    A therapeutic success refers to participants who have been deemed both a "microbiological success" and a "clinical success". All other combinations (other than clinical success + microbiological success) will be deemed failures for therapeutic response.


Secondary Outcome Measures :
  1. Number of participants with clinical outcome at the TOC visit [ Time Frame: Up to Day 13 ]
    The clinical signs and symptoms score for acute cystitis will be determined by the investigator and used to programmatically determine the clinical outcome.

  2. Number of participants with clinical outcome at the follow up visit [ Time Frame: Up to Day 31 ]
    The clinical signs and symptoms score for acute cystitis will be determined by the investigator and used to programmatically determine the clinical outcome.

  3. Number of participants with clinical response at the TOC visit [ Time Frame: Up to Day 13 ]
    The clinical signs and symptoms score for acute cystitis will be determined by the investigator and used to programmatically determine the clinical response.

  4. Number of participants with clinical response at the follow up visit [ Time Frame: Up to Day 31 ]
    The clinical signs and symptoms score for acute cystitis will be determined by the investigator and used to programmatically determine the clinical response.

  5. Number of participants with microbiological outcome at the TOC visit [ Time Frame: Up to Day 13 ]
    The microbiological outcome to study intervention will be determined by pre-specified programmed algorithm for each participant or uropathogen. The microbiological outcome by Baseline qualifying uropathogen will be determined by comparing the baseline culture results to the culture results at each subsequent visit.

  6. Number of participants with microbiological outcome at the follow up visit [ Time Frame: Up to Day 31 ]
    The microbiological outcome to study intervention will be determined by pre-specified programmed algorithm for each participant or uropathogen. The microbiological outcome by baseline qualifying uropathogen will be determined by comparing the baseline culture results to the culture results at each subsequent visit.

  7. Number of participants with microbiological response at the TOC visit [ Time Frame: Up to Day 13 ]
    The microbiological response to study intervention will be determined by pre-specified programmed algorithm for each participant or uropathogen.

  8. Number of participants with microbiological response at the follow up visit [ Time Frame: Up to Day 31 ]
    The microbiological response to study intervention will be determined by pre-specified programmed algorithm for each participant or uropathogen

  9. Number of participants with therapeutic response at the follow up visit [ Time Frame: Up to Day 31 ]
    A therapeutic success refers to participants who have been deemed both a "microbiological success" and a "clinical success". All other combinations (other than clinical success + microbiological success) will be deemed failures for therapeutic response.

  10. Number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Day 31 ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation that require medical or scientific judgment.

  11. Change from Baseline in neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count (Giga cells per Liter) [ Time Frame: Baseline and up to Day 13 ]
    Blood samples will be collected for the assessment of neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count.

  12. Change from Baseline in hemoglobin level (grams per deciliter) [ Time Frame: Baseline and up to Day 13 ]
    Blood samples will be collected for the assessment of hemoglobin level.

  13. Change from Baseline in hematocrit level (Proportion of red blood cells in blood) [ Time Frame: Baseline and up to Day 13 ]
    Blood samples will be collected for the assessment of hematocrit level

  14. Change from Baseline in red blood cell (RBC) count (Trillion cells per liter) [ Time Frame: Baseline and up to Day 13 ]
    Blood samples will be collected for the assessment of RBC count.

  15. Change from Baseline in mean corpuscular hemoglobin (MCH) (Picograms) [ Time Frame: Baseline and up to Day 13 ]
    Blood samples will be collected for the assessment of MCH

  16. Change from Baseline in mean corpuscular volume (MCV) (Femtoliters) [ Time Frame: Baseline and up to Day 13 ]
    Blood samples will be collected for the assessment of MCV.

  17. Change from Baseline in blood urea nitrogen (BUN), glucose non-fasting, calcium, chloride, sodium, magnesium, phosphorus, and potassium levels (millimoles per liter) [ Time Frame: Baseline and up to Day 13 ]
    Blood samples will be collected for the assessment of BUN, glucose non-fasting, calcium, chloride, magnesium, phosphorus, sodium and potassium levels.

  18. Change from Baseline in total bilirubin, direct bilirubin and creatinine levels (micromoles per Liter) [ Time Frame: Baseline and up to Day 13 ]
    Blood samples will be collected for the assessment of total bilirubin, direct bilirubin and creatinine levels.

  19. Change from Baseline in albumin and total protein levels (gram per Liter) [ Time Frame: Baseline and up to Day 13 ]
    Blood samples will be collected for the assessment of albumin and total protein levels.

  20. Change from Baseline in aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels (International units per Liter) [ Time Frame: Baseline and up to Day 13 ]
    Blood samples will be collected for the assessment of AST, ALT and alkaline phosphatase levels.

  21. Number of participants with abnormal urinalysis Dipstick results [ Time Frame: Up to Day 13 ]
    Urine samples will be collected to assess pH, glucose, protein, nitrite, leukocyte esterase, blood and ketones by Dipstick method. Microscopic examination will be performed if blood or protein will be abnormal.

  22. Change from Baseline in specific gravity of urine [ Time Frame: Baseline and up to Day 13 ]
    Urine samples will be collected for the measurement of specific gravity.

  23. Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) [ Time Frame: Baseline and up to Day 13 ]
    SBP and DBP will be assessed in a semi-supine position after 5 minutes rest.

  24. Change from Baseline in pulse rate [ Time Frame: Baseline and up to Day 13 ]
    Pulse rate will be assessed in a semi-supine position after 5 minutes rest.

  25. Change from Baseline in body temperature [ Time Frame: Baseline and up to Day 13 ]
    Changes in body temperature from Baseline will be assessed.

  26. Change from Baseline in PR, QRS, QT, and corrected QT interval (QTc) intervals (milliseconds [msec]) [ Time Frame: Baseline and up to Day 4 ]
    Twelve lead electrocardiograms (ECG) will be obtained using an ECG machine that will automatically measure the PR, QRS, QT and QTc intervals.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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 <=72 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain
  • The participant has nitrite or pyuria (>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.
  • Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    • A female participant is eligible to participate if she is a woman of childbearing potential (WOCBP) who is not pregnant as confirmed by a high sensitivity urine pregnancy test at Baseline (Day 1) regardless of current or prior contraception use or abstinence, is not breastfeeding, or is not a WOCBP.
    • Additional requirements for pregnancy testing during and after study intervention are specified.
    • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • The participant is capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)/assent form and protocol.

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 high blood pressure or uncontrolled diabetes.
  • The participant has a history of sensitivity to the study interventions, 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 (e.g., uncontrolled diabetes, renal transplant recipients, participants with clinically significant persistent granulocytopenia [absolute neutrophil count <1000/microliter (μL)], and participants receiving immunosuppressive therapy, including corticosteroid therapy [>40 milligrams (mg)/day prednisolone or equivalent for >1 week, >=20 mg/day prednisolone or equivalent for >2 weeks, or prednisolone or equivalent >=10 mg/day for >6 weeks]). Participants with a known cluster of differentiation 4 (CD4) count of <200 cells per cubic millimeter (cells/mm^3) should not be enrolled.
  • The participant has any of the following: Medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as;

    • Medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as:
    • Poorly controlled asthma or chronic obstructive pulmonary disease at Baseline and, in the opinion of the investigator, not stable on current therapy
    • Acute severe pain, uncontrolled with conventional medical management
    • Active peptic ulcer disease
    • Parkinson disease
    • Myasthenia gravis
    • A history of seizure disorder requiring medications for control (this does not include a history of childhood febrile seizures) or
    • Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention (e.g., ileostomy or malabsorption syndrome)
  • 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 Enterobacteriaceae (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.
  • The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic 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 degree Fahrenheit, 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 or a strong P-glycoprotein (P-gp) inhibitor.
  • For any participant >=12 to <18 years of age, the participant has an abnormal ECG reading at Baseline or during the study intervention.
  • 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 × upper limit of normal (ULN).
  • The participant has a known bilirubin value >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • 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.
  • The participant must agree not to use the medications or nondrug therapies from the Baseline Visit through the TOC Visit
  • The participant has been previously enrolled in this study or has previously been treated with gepotidacin.
  • The participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187144


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Florida
GSK Investigational Site Recruiting
Hialeah, Florida, United States, 33013
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Wilfrido Benitez         
United States, Georgia
GSK Investigational Site Recruiting
Woodstock, Georgia, United States, 30189
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Bram Derek Wieskopf         
United States, New York
GSK Investigational Site Recruiting
Brooklyn, New York, United States, 11229
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Michael Yuryev         
United States, North Carolina
GSK Investigational Site Recruiting
Cary, North Carolina, United States, 27518
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sylvia P Shoffner         
GSK Investigational Site Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Gregory P. Tarleton         
United States, Ohio
GSK Investigational Site Recruiting
Cincinnati, Ohio, United States, 45215
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Blaise Gatto         
GSK Investigational Site Recruiting
Columbus, Ohio, United States, 43214
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Narinder Saini         
GSK Investigational Site Recruiting
Columbus, Ohio, United States, 43231
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Milroy Samuel         
GSK Investigational Site Recruiting
Dayton, Ohio, United States, 45424
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Steve Choi         
United States, Texas
GSK Investigational Site Recruiting
Houston, Texas, United States, 77061
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Rabia Shaukat         
GSK Investigational Site Recruiting
Mesquite, Texas, United States, 75149
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Salma Saiger         
GSK Investigational Site Recruiting
Missouri City, Texas, United States, 77459
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Deirdre Mcmullen         
GSK Investigational Site Recruiting
San Antonio, Texas, United States, 78209
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Robert Morin Jr         
GSK Investigational Site Recruiting
San Antonio, Texas, United States, 78251
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Linda Ingeborg Esquivel         
United States, Utah
GSK Investigational Site Recruiting
Bountiful, Utah, United States, 84010
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Allison Hanna         
GSK Investigational Site Recruiting
Saint George, Utah, United States, 84790
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Joseph H. Woolley         
GSK Investigational Site Recruiting
Saint George, Utah, United States, 84790
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jonathon Hubbard         
Sponsors and Collaborators
GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04187144    
Other Study ID Numbers: 212390
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Acute cystitis
Gepotidacin
Nitrofurantoin
Urinary Tract Infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Bacterial Infections
Urologic Diseases
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents