EUCTR2018-001801-98-HU进行中（未招募）1 期
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).
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- The participant is =12 years of age at the time of signing the informed consent/assent and has a body weight = 40 kg. Note: Although participants as young as 12 years may enroll in the study, study sites must follow their institutional ethics committee and local country/national regulatory guidelines and enrollment will be contingent upon such approvals regarding the allowed lower age limit for clinical study participants.
- •-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 (>15WBC/HPFor the presence of 3+/large leukocyte esterase)from a pretreatment clean-catch midstream urine sample based on local laboratory procedures.
- •-The participant is female. A female participant is eligible to participate if she is woman of childbearing potential (WOCBP) who is not pregnant as confirmed by high sensitivity urine pregnancy test at Baseline (day1) regardless of current or prior contraception or abstinence, is not breastfeeding, or is not a WOCBP (note: pregnancy test requirements, contraceptive guidance, and WOCBP definitions are provided in Appendix 6 of Protocol).
- •- 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 in this protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 960
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •-The participant resides in a nursing home or dependent care type-facility AND has a body mass index =40.0 kg/m2 or a body mass index =35.0kg/m2 and is experiencing obesity-related health conditions such as 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, 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, and participants receiving immunosuppressive therapy, including corticosteroid therapy.
- •-Participants with a known CD4 count of <200 cells/mm3 should not be enrolled.
- •-Participant has any of the following: /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 treatment).
- •-Participant has a known glucose-6-phosphate dehydrogenase deficiency and in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
- •-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
- •-Participant has symptoms known or suspected to be caused by another disease process,ex overactive bladder, chronic incontinence, or chronic interstitial cystitis, that interfere with the clinical efficacy assessments.
- •-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, or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract
- •-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, signs and symptom onset =96hours before study entry, or a temperature =101°F, flank pain, chills, or any other manifestations suggestive of upper UTI.
- •-Participant has known anuria, oliguria, or significant impairment of renal function or presents with vaginal discharge at Baseline.
- •-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 OR has a recent history of vasovagal syncopeor episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months.
- •-Participant is taking QT-pro
研究者
相似试验
进行中（未招募）
3 期
This research study is being done to learn more about bladder infections also known as uncomplicated urinary tract infection (uUTI), and if a new medicine called gepotidacin can be used for this infectioCTRI/2020/07/026741GlaxoSmithKlineResearchandDevelopmentLimited
进行中（未招募）
1 期
Phase III, Double-Blind, Parallel-Group, Comparator-Controlled,Efficacy and Safety Study of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis).rinary Tract Infection (Acute Cystitis)MedDRA version: 20.0Level: PTClassification code 10011781Term: CystitisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2018-001801-98-SKGlaxoSmithKline Research & Development Limited1,200
进行中（未招募）
1 期
Phase III, Double-Blind, Parallel-Group, Comparator-Controlled, Efficacy and Safety Study of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)EUCTR2020-000553-27-PLGlaxoSmithKline Research & Development Limited1,200
进行中（未招募）
1 期
Phase III, Double-Blind, Parallel-Group, Comparator-Controlled, Efficacy and Safety Study of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)EUCTR2020-000553-27-BGGlaxoSmithKline Research & Development Limited1,605
进行中（未招募）
1 期
Phase III, Double-Blind, Parallel-Group, Comparator-Controlled,Efficacy and Safety Study of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis).EUCTR2018-001801-98-GRGlaxoSmithKline Research & Development Limited1,531