GonorrheaPhase 3NCT04010539
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
A Phase 3 study testing Gepotidacin, Ceftriaxone and Azithromycin in people with Gonorrhea, run by GlaxoSmithKline at 51 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Gonorrhea
- What is being tested?
- Gepotidacin, Ceftriaxone and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 51 sitesin 6 countries
- Study dates
- 21 Oct 2019to 10 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
51 sites in 6 countries.
51 sites in 6 countries
United States13 sites
GSK Investigational Site
Cleveland, Ohio, 44109
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Fayetteville, North Carolina, 28303-5537
GSK Investigational Site
Greensboro, North Carolina, 27405
GSK Investigational Site
Houston, Texas, 77098
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Longview, Texas, 75602
GSK Investigational Site
Los Angeles, California, 90036
GSK Investigational Site
New Orleans, Louisiana, 70119
GSK Investigational Site
Orlando, Florida, 32803
GSK Investigational Site
Palm Springs, California, 92262
GSK Investigational Site
Springfield, Massachusetts, 01105
Spain11 sites
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Barcelona, 08041
GSK Investigational Site
Barcelona, 08950
GSK Investigational Site
Barcelona, ?08015
GSK Investigational Site
Barcelona, ?08907
GSK Investigational Site
Bilbao, 48010
GSK Investigational Site
Madrid, 28010
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Seville, 41013
United Kingdom11 sites
GSK Investigational Site
Birmingham, B4 6DH
GSK Investigational Site
Brighton, BN2 1ES
GSK Investigational Site
Edinburgh, EH3 9ES
GSK Investigational Site
Leeds, LS1 3EX
GSK Investigational Site
London, E9 6SR
GSK Investigational Site
London, W2 1NY
GSK Investigational Site
London, W6 7AL
GSK Investigational Site
London, WC1E 6JB
GSK Investigational Site
Manchester, M13 0FH
GSK Investigational Site
Reading, RG1 5SL
GSK Investigational Site
St Helens, WA9 3DA
Germany8 sites
GSK Investigational Site
Berlin, 10243
GSK Investigational Site
Berlin, 10439
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50924
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Hamburg, 20146
GSK Investigational Site
München, 80336
GSK Investigational Site
Munich, Bavaria, 81675
Australia5 sites
GSK Investigational Site
Carlton, Victoria, 3053
GSK Investigational Site
Darlinghurst, New South Wales, 2010
GSK Investigational Site
Darlinghurst, Sydney, New South Wales, 2010
GSK Investigational Site
Prahran, Victoria, 3181
GSK Investigational Site
Southport, Queensland, 4215
Mexico3 sites
GSK Investigational Site
Guadalajara, Jalisco, 44160
GSK Investigational Site
Guadalajara, Jalisco, 44280
GSK Investigational Site
Monterrey, 64460
About this study
Official 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
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.
- Conditions
- Gonorrhea
- Being tested
- Gepotidacin, Ceftriaxone, Azithromycin
- Keywords
- Urogenital Gonorrhea, Gepotidacin, Neisseria gonorrhoeae, Efficacy, Phase 3
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GepotidacinDrug
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.
CeftriaxoneDrug
Ceftriaxone is available as sterile powder for reconstitution. It will be administered as one 500-mg IM dose at the study site.
AzithromycinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Gepotidacin |
| 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. Receives: Drug: Ceftriaxone; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Secondary outcomes (19)
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit
Rectal 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.
Measured: 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
Pharyngeal 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.
Measured: 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)
An adverse event (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. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
Measured: Up to 21 days
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Blood samples were collected for the assessment of change from baseline in hematology parameters: basophils, eosinophil, leukocytes, neutrophils, platelets, lymphocytes, monocytes, neutrophils and nucleated erythrocytes. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)
Blood samples were collected for the assessment of change from baseline in hematology parameters: mean corpuscular hemoglobin concentration and hemoglobin. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected for the assessment of change from baseline in hematology parameter: hematocrit. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected for the assessment of change from baseline in hematology parameter: red blood cell (RBC) count. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular hemoglobin (MCH). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular volume (MCV). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: urea nitrogen (UN), glucose, calcium, chloride, sodium, magnesium and potassium. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: bilirubin, direct bilirubin and creatinine levels. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: albumin and protein. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: 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)
Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Number of Participants With Urinalysis Dipstick Results
Urine samples were collected for urinalysis: Glucose, Protein, Occult Blood and Ketones. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Small, Moderate, Large, Positive, 5 milligram per deciliter (mg/dL), 20 mg/dL, 30 mg/dL 50 mg/dL, 100 mg/dL, 150 mg/dL and >=500 mg/dL indicating concentrations in the urine sample. In the row title (Glucose, Baseline, Negative), Glucose indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Absolute Values in Specific Gravity of Urine
Urine samples were collected from participants to assess urine specific gravity. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Absolute Values in Potential of Hydrogen (pH) of Urine
Urine samples were collected from participants to assess urine pH. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: 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)
SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Vital Sign: Pulse Rate
Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Vital Sign: Temperature
Temperature was measured after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Measured: Baseline (Day 1) and TOC visit (Day 4 to 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start21 Oct 2019
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010539
- Sponsor's protocol ID
- 116577
- Other IDs
- 2018-001780-23, 2018
- Status last verified
- Apr 2024
- First submitted
- 2 Jul 2019
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Publications
Jakielaszek C, Flight W, Lythgoe D, Perry C, Scangarella-Oman NE. In vitro activity of gepotidacin against baseline Neisseria gonorrhoeae phenotypes and genotypes recovered from a clinical trial for uncomplicated urogenital gonorrhea (EAGLE-1). Antimicrob Agents Chemother. 2026 Oct 7:e0075226. doi: 10.1128/aac.00752-26. Online ahead of print.
PubMed 42841733Ross JDC, Wilson J, Workowski KA, Taylor SN, Lewis DA, Gatsi S, Flight W, Scangarella-Oman NE, Jakielaszek C, Lythgoe D, Powell M, Janmohamed S, Absalon J, Perry C. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. Lancet. 2025 May 3;405(10489):1608-1620. doi: 10.1016/S0140-6736(25)00628-2. Epub 2025 Apr 14.
PubMed 40245902Perry CR, Scangarella-Oman NE, Millns H, Flight W, Gatsi S, Jakielaszek C, Janmohamed S, Lewis DA. Efficacy and Safety of Gepotidacin as Treatment of Uncomplicated Urogenital Gonorrhea (EAGLE-1): Design of a Randomized, Comparator-Controlled, Phase 3 Study. Infect Dis Ther. 2023 Sep;12(9):2307-2320. doi: 10.1007/s40121-023-00862-6. Epub 2023 Sep 26.
PubMed 37751016Fishman C, Caverly Rae JM, Posobiec LM, Laffan SB, Lerman SA, Pearson N, Janmohamed S, Dumont E, Nunn-Floyd D, Stanislaus DJ. Novel Bacterial Topoisomerase Inhibitor Gepotidacin Demonstrates Absence of Fluoroquinolone-Like Arthropathy in Juvenile Rats. Antimicrob Agents Chemother. 2022 Nov 15;66(11):e0048322. doi: 10.1128/aac.00483-22. Epub 2022 Oct 18.
PubMed 36255258
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04010539
- Acronym / sponsor ID
- 116577
- Conditions
- Gonorrhea
- Keywords
- Urogenital Gonorrhea, Gepotidacin, Neisseria gonorrhoeae, Efficacy, Phase 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 30 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving Gepotidacin | Experimental | Drug: GepotidacinParticipants 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. |
| Participants receiving Ceftriaxone plus Azithromycin | Active comparator | Drug: Ceftriaxone, Drug: AzithromycinParticipants 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GepotidacinGepotidacin 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. | Drug | Participants receiving Gepotidacin |
| CeftriaxoneCeftriaxone is available as sterile powder for reconstitution. It will be administered as one 500-mg IM dose at the study site. | Drug | Participants receiving Ceftriaxone plus Azithromycin |
| AzithromycinAzithromycin 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. | Drug | Participants receiving Ceftriaxone plus Azithromycin |
Primary outcome
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)
Time frame: 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.
19 secondary outcomes
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit
Time frame: 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
Time frame: 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)
Time frame: Up to 21 days
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Hematology Parameter: Hematocrit
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Hematology Parameter: Erythrocytes
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Time frame: 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)
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Number of Participants With Urinalysis Dipstick Results
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Absolute Values in Specific Gravity of Urine
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Absolute Values in Potential of Hydrogen (pH) of Urine
Time frame: 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)
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Vital Sign: Pulse Rate
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Change From Baseline in Vital Sign: Temperature
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42841733Jakielaszek C, Flight W, Lythgoe D, Perry C, Scangarella-Oman NE. In vitro activity of gepotidacin against baseline Neisseria gonorrhoeae phenotypes and genotypes recovered from a clinical trial for uncomplicated urogenital gonorrhea (EAGLE-1). Antimicrob Agents Chemother. 2026 Oct 7:e0075226. doi: 10.1128/aac.00752-26. Online ahead of print.
- Derived from this study: PubMed 40245902Ross JDC, Wilson J, Workowski KA, Taylor SN, Lewis DA, Gatsi S, Flight W, Scangarella-Oman NE, Jakielaszek C, Lythgoe D, Powell M, Janmohamed S, Absalon J, Perry C. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. Lancet. 2025 May 3;405(10489):1608-1620. doi: 10.1016/S0140-6736(25)00628-2. Epub 2025 Apr 14.
- Derived from this study: PubMed 37751016Perry CR, Scangarella-Oman NE, Millns H, Flight W, Gatsi S, Jakielaszek C, Janmohamed S, Lewis DA. Efficacy and Safety of Gepotidacin as Treatment of Uncomplicated Urogenital Gonorrhea (EAGLE-1): Design of a Randomized, Comparator-Controlled, Phase 3 Study. Infect Dis Ther. 2023 Sep;12(9):2307-2320. doi: 10.1007/s40121-023-00862-6. Epub 2023 Sep 26.
- Derived from this study: PubMed 36255258Fishman C, Caverly Rae JM, Posobiec LM, Laffan SB, Lerman SA, Pearson N, Janmohamed S, Dumont E, Nunn-Floyd D, Stanislaus DJ. Novel Bacterial Topoisomerase Inhibitor Gepotidacin Demonstrates Absence of Fluoroquinolone-Like Arthropathy in Juvenile Rats. Antimicrob Agents Chemother. 2022 Nov 15;66(11):e0048322. doi: 10.1128/aac.00483-22. Epub 2022 Oct 18.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
51 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gepotidacin, Ceftriaxone and Azithromycin in people with Gonorrhea, run by GlaxoSmithKline at 51 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Spain, United Kingdom, Germany, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04010539, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.