NCT04010539已完成3 期
A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 628
- 试验地点
- 1
- 主要终点
- Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8)
研究概览
简要总结
This is a phase III, randomized, multicenter, open-label study which will be performed to evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae (N. gonorrhoeae) in adolescent and adult participants. In this study, participants will be randomly assigned to receive either oral gepotidacin or IM ceftriaxone plus oral azithromycin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be >=12 years of age at the time of signing the informed consent.
- •Participants having body weight of >45 kilogram (kg).
- •Participants having clinical suspicion of a urogenital gonococcal infection with or without pharyngeal and/or rectal gonococcal infection and have one of the following: male participants with purulent yellow, green, or white urethral discharge or female participants with abnormal cervical or vaginal mucopurulent discharge upon physical examination; or a prior positive culture for N. gonorrhoeae from up to 5 days before screening (as long as the participant has not received any treatment for this infection); or a Gram or equivalent stain (urogenital specimens only) positive or presumptive for Gram-negative intracellular diplococci from up to 5 days before screening (as long as the participant has not received any treatment for this infection); or a prior positive nucleic acid amplification test assay for N. gonorrhoeae from up to 7 days before screening (as long as the participant has not received any treatment for this infection).
- •Participants who are willing to avoid anal, oral, and vaginal sexual intercourse or use condoms for all forms of intercourse from the Baseline Visit through the TOC Visit.
- •Male or female participants having his or her original urogenital anatomy at birth.
- •Male participant must agree to use contraception (male condoms) during intercourse from the Baseline Visit through completion of the TOC Visit.
- •Female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance (male partners of WOCBP must use a male condom during intercourse) from the Baseline Visit through completion of the TOC Visit.
- •Participants who are capable of giving signed informed consent or assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) or assent form and in study protocol.
排除标准
- •Male participants with a current diagnosis of epididymitis and/or orchitis at the time of the Baseline Visit.
- •Participant who is suspected or confirmed to have a Chlamydia trachomatis infection and per the investigator's judgement standard-of-care treatment for this infection cannot be safely postponed until the TOC Visit.
- •Participant has a body mass index >=40 kilogram per square meter (kg/m^2) or has a body mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditions such as high blood pressure or diabetes.
- •Participant has a history of sensitivity to the study treatments, or components thereof, or a history of a drug (including erythromycin and any macrolide or ketolide drug) or other allergy that, in the opinion of the investigator or medical monitor, contraindicates his or 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.
- •Participants with a known cluster of differentiation 4 (CD4) count of <200 cells per cubic millimeter (cells/mm^3).
- •Participant has any of the following: poorly controlled asthma or chronic obstructive pulmonary disease, 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 or participant has any surgical or medical condition that may interfere with drug absorption, distribution, metabolism, or excretion of the study treatment.
- •Participant has known anuria, oliguria, or severe impairment of renal function (creatinine clearance <30 milliliter per minute [mL/min] or clinically significant elevated serum creatinine as determined by the investigator).
- •Participant 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 congenital long QT syndrome or known prolongation of corrected QT interval (QTc).
- •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 bradyarrhythmia 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 his or 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, the participant has an abnormal electrocardiogram (ECG) reading.
- •The 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 history of cholestatic jaundice or hepatic dysfunction associated with prior use of azithromycin.
- •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%).
- •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 been previously randomized in this study or has previously been treated with Gepotidacin.
- •Participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.
- •Participant has any of the following gonococcal infections that require a different dose or duration of treatment: suspected or confirmed pelvic inflammatory disease; or suspected or confirmed gonococcal arthritis; or suspected or confirmed gonococcal conjunctivitis; or suspected or confirmed gonococcal endocarditis; or other evidence of disseminated gonococcal infection.
- •Participant has received any antibacterial therapy for the treatment of a gonococcal infection within 14 days before the Baseline Visit.
- •Participant has received any systemic, topical, or intravaginal antibiotics or any systemic antifungals within 7 days before the Baseline Visit.
- •Participant must not use St John's wort or ergot derivatives from within 14 days before the Baseline Visit through the TOC Visit.
研究组 & 干预措施
Participants receiving Gepotidacin
Experimental
Participants will receive Gepotidacin orally at the study site during the Baseline (Day 1) visit followed by self-administration of a second oral dose as an outpatient 10 to 12 hours after the first dose.
干预措施: Gepotidacin (Drug)
Participants receiving Ceftriaxone plus Azithromycin
Active Comparator
Participants will receive a single IM dose of Ceftriaxone plus a single oral dose of Azithromycin at the study site during the Baseline (Day 1) visit.
干预措施: Ceftriaxone (Drug)
Participants receiving Ceftriaxone plus Azithromycin
Active Comparator
Participants will receive a single IM dose of Ceftriaxone plus a single oral dose of Azithromycin at the study site during the Baseline (Day 1) visit.
干预措施: Azithromycin (Drug)
结局指标
主要结局
Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8)
时间窗: Baseline (Day 1) and TOC visit (Day 4 to 8)
Urogenital specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.
次要结局
- Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Change From Baseline in Hematology Parameter: Hematocrit(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs)(Up to 21 days)
- Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Change From Baseline in Hematology Parameter: Erythrocytes(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP)(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Change From Baseline in Vital Sign: Pulse Rate(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Number of Participants With Urinalysis Dipstick Results(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Absolute Values in Potential of Hydrogen (pH) of Urine(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Change From Baseline in Vital Sign: Temperature(Baseline (Day 1) and TOC visit (Day 4 to 8))
- Absolute Values in Specific Gravity of Urine(Baseline (Day 1) and TOC visit (Day 4 to 8))
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