Phase III, Double-Blind, Parallel-Group, Comparator-Controlled, Efficacy and Safety Study of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
- Conditions
- rinary Tract Infection (Acute Cystitis)MedDRA version: 20.0Level: PTClassification code 10011781Term: CystitisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2020-000553-27-BG
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1605
Otherwise healthy participants are eligible to be included in the study only if all of the following criteria apply:
Age
1.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.
Type of Participant and Disease Characteristics
2.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 (see Appendix 5).
3.The participant has nitrite or pyuria (>15 WBC/HPF or the presence of 3+/large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures.
Sex
4. 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.
Note: Pregnancy testing requirements, contraceptive guidance, and WOCBP definitions are provided in Appendix 2 and Appendix 6.
Additional requirements for pregnancy testing during and after study intervention are located in Appendix 6.
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.
Informed Consent
5.The participant is capable of giving signed informed consent/assent as described in Appendix 3 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
-The participant resides in a nursing home or dependent care typefacility
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
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,
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/known Acute porphyria/any surgical or medical condition 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 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, 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- (=38°C), 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-prolongin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method