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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04010539




Registration number
NCT04010539
Ethics application status
Date submitted
2/07/2019
Date registered
8/07/2019

Titles & IDs
Public title
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
Scientific title
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
Secondary ID [1] 0 0
2018-001780-23
Secondary ID [2] 0 0
116577
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gonorrhea 0 0
Condition category
Condition code
Infection 0 0 0 0
Sexually transmitted infections
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gepotidacin
Treatment: Drugs - Ceftriaxone
Treatment: Drugs - Azithromycin

Experimental: Participants receiving Gepotidacin - 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.

Active comparator: Participants receiving Ceftriaxone plus Azithromycin - 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.


Treatment: Drugs: Gepotidacin
Gepotidacin will be administered as 3000 milligram (mg) oral dose (4 X 750 mg tablets) at the study site followed by 3000 mg oral dose (4 X 750 mg tablets) as an outpatient. Each dose should be taken after food consumption and with water.

Treatment: Drugs: Ceftriaxone
Ceftriaxone is available as sterile powder for reconstitution. It will be administered as one 500-mg IM dose at the study site.

Treatment: Drugs: Azithromycin
Azithromycin will be administered as 1000 mg oral dose (2 X 500 mg tablets) at the study site. Dose should be taken after food consumption and with water.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [1] 0 0
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit
Timepoint [1] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [2] 0 0
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit
Timepoint [2] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [3] 0 0
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Up to 21 days
Secondary outcome [4] 0 0
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Timepoint [4] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [5] 0 0
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)
Timepoint [5] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [6] 0 0
Change From Baseline in Hematology Parameter: Hematocrit
Timepoint [6] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [7] 0 0
Change From Baseline in Hematology Parameter: Erythrocytes
Timepoint [7] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [8] 0 0
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Timepoint [8] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [9] 0 0
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Timepoint [9] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [10] 0 0
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Timepoint [10] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [11] 0 0
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine
Timepoint [11] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [12] 0 0
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Timepoint [12] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [13] 0 0
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP)
Timepoint [13] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [14] 0 0
Number of Participants With Urinalysis Dipstick Results
Timepoint [14] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [15] 0 0
Absolute Values in Specific Gravity of Urine
Timepoint [15] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [16] 0 0
Absolute Values in Potential of Hydrogen (pH) of Urine
Timepoint [16] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [17] 0 0
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Timepoint [17] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [18] 0 0
Change From Baseline in Vital Sign: Pulse Rate
Timepoint [18] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcome [19] 0 0
Change From Baseline in Vital Sign: Temperature
Timepoint [19] 0 0
Baseline (Day 1) and TOC visit (Day 4 to 8)

Eligibility
Key inclusion criteria
* 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/10/2023
Sample size
Target
Accrual to date
Final
628
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst, Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
GSK Investigational Site - Southport
Recruitment hospital [4] 0 0
GSK Investigational Site - Carlton
Recruitment hospital [5] 0 0
GSK Investigational Site - Prahran
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst, Sydney
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Germany
State/province [10] 0 0
Bayern
Country [11] 0 0
Germany
State/province [11] 0 0
Hessen
Country [12] 0 0
Germany
State/province [12] 0 0
Nordrhein-Westfalen
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Germany
State/province [15] 0 0
München
Country [16] 0 0
Mexico
State/province [16] 0 0
Jalisco
Country [17] 0 0
Mexico
State/province [17] 0 0
Monterrey
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Bilbao
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Sevilla
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Birmingham
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Brighton
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Edinburgh
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Leeds
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Manchester
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Reading
Country [29] 0 0
United Kingdom
State/province [29] 0 0
St Helens

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04010539