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A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010539
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : December 28, 2022
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief 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. gonorrhoeae) in adolescent and adult subjects. In this study, subjects will be randomly assigned to receive either oral gepotidacin or IM ceftriaxone plus oral azithromycin. Approximately 600 subjects will be randomized to receive study treatment. The duration of the study will be approximately 21 days.

Condition or disease Intervention/treatment Phase
Gonorrhea Drug: Gepotidacin Drug: Ceftriaxone Drug: Azithromycin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gonorrhea

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Gepotidacin
Subjects 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.
 Drug: 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.
Active Comparator: Ceftriaxone plus Azithromycin
Subjects 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.
 Drug: Ceftriaxone
Ceftriaxone is available as sterile powder for reconstitution. It will be administered as one 500-mg IM dose at the study site.

Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site at the Test-of-Cure (TOC) [ Time Frame: Up to Day 8 ]
    Pre-treatment urogenital swab specimen will be obtained for bacteriological culture for N. gonorrhoeae. Test-of-Cure is defined by urogenital site as culture-confirmed bacterial eradication of N. gonorrhoeae observed 4 to 8 days post-treatment.


Secondary Outcome Measures :
  1. Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the rectal site at the TOC [ Time Frame: Up to Day 8 ]
    Pre-treatment rectal swab specimen will be obtained for bacteriological culture for N. gonorrhoeae. Test-of-Cure is defined by rectal site as culture-confirmed bacterial eradication of N. gonorrhoeae observed 4 to 8 days post-treatment.

  2. Number of subjects with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the pharyngeal site at the TOC [ Time Frame: Up to Day 8 ]
    Pre-treatment pharyngeal swab specimen will be obtained for bacteriological culture for N. gonorrhoea. Test-of-Cure is defined by pharyngeal site as culture-confirmed bacterial eradication of N. gonorrhoea observed 4 to 8 days post-treatment

  3. Number of subjects with treatment-emergent adverse events and serious adverse events (SAEs) [ Time Frame: Up to Day 21 ]
    An adverse event (AE) is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity, is a congenital anomaly or birth defect, any other situation that require medical or scientific judgment.

  4. Change from Baseline in neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count [ Time Frame: Baseline and up to Day 8 ]
    Blood samples will be collected for the assessment of neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count. All parameters have "Giga cells per Liter" as unit of measure.

  5. Change from Baseline in hemoglobin level [ Time Frame: Baseline and up to Day 8 ]
    Blood samples will be collected for the assessment of hemoglobin level.

  6. Change from Baseline in hematocrit level [ Time Frame: Baseline and up to Day 8 ]
    Blood samples will be collected for the assessment of hematocrit level.

  7. Change from Baseline in red blood cell (RBC) count [ Time Frame: Baseline and up to Day 8 ]
    Blood samples will be collected for the assessment of RBC count.

  8. Change from Baseline in mean corpuscular hemoglobin (MCH) [ Time Frame: Baseline and up to Day 8 ]
    Blood samples will be collected for the assessment of MCH.

  9. Change from Baseline in mean corpuscular volume (MCV) [ Time Frame: Baseline and up to Day 8 ]
    Blood samples will be collected for the assessment of MCV.

  10. Change from Baseline in blood urea nitrogen, glucose non-fasting, calcium, chloride, sodium and potassium levels [ Time Frame: Baseline and up to Day 8 ]
    Blood samples will be collected for the assessment of blood urea nitrogen, glucose non-fasting, calcium, chloride, sodium and potassium levels. All parameters have "Millimole per Liter" as unit of measure.

  11. Change from Baseline in total bilirubin, direct bilirubin and creatinine levels [ Time Frame: Baseline and up to Day 8 ]
    Blood samples will be collected for the assessment of total bilirubin, direct bilirubin and creatinine levels. All parameters have "Micromoles per liter" as unit of measure.

  12. Change from Baseline in albumin and total protein levels [ Time Frame: Baseline and up to Day 8 ]
    Blood samples will be collected for the assessment of albumin and total protein levels. All parameters have "Gram per liter" as unit of measure.

  13. Change from Baseline in aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels [ Time Frame: Baseline and up to Day 8 ]
    Blood samples will be collected for the assessment of AST, ALT and alkaline phosphatase levels. All parameters have "International units per Liter" as unit of measure.

  14. Number of subjects with abnormal urinalysis Dipstick results [ Time Frame: Up to Day 8 ]
    Urine samples will be collected to assess pH, glucose, protein, blood and ketones by Dipstick method.

  15. Change from Baseline in specific gravity of urine [ Time Frame: Baseline and up to Day 8 ]
    Urine samples will be collected for the measurement of specific gravity.

  16. Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) [ Time Frame: Baseline and up to Day 8 ]
    SBP and DBP will be assessed in the semi-supine position after 5 minutes rest.

  17. Change from Baseline in pulse rate [ Time Frame: Baseline and up to Day 8 ]
    Pulse measurements will be assessed in the semi-supine position after 5 minutes rest.

  18. Change from Baseline in body temperature [ Time Frame: Baseline and up to Day 8 ]
    Changes in body temperature from Baseline will be assessed.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be >=12 years of age at the time of signing the informed consent.
  • Subjects having body weight of >45 kilogram (kg).
  • Subjects having clinical suspicion of a urogenital gonococcal infection with or without pharyngeal and/or rectal gonococcal infection and have one of the following: male subjects with purulent yellow, green, or white urethral discharge or female subjects 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 subject has not received any treatment for this infection); or a Gram stain (urogenital specimens only) positive or presumptive for Gram-negative intracellular diplococci from up to 5 days before screening (as long as the subject 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 subject has not received any treatment for this infection).
  • Subjects 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 subjects having his or her original urogenital anatomy at birth.
  • Male subject must agree to use contraception (male condoms) during intercourse from the Baseline Visit through completion of the TOC Visit.
  • Female subject 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.
  • Subjects 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.

Exclusion Criteria:

  • Male subjects with a current diagnosis of epididymitis and/or orchitis at the time of the Baseline Visit.
  • Subject 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.
  • Subject 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.
  • Subject 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.
  • Subject is immunocompromised or has altered immune defenses that may predispose the subject to a higher risk of treatment failure and/or complications. For example, subjects with diabetes, renal transplant recipients, subjects with clinically significant persistent granulocytopenia (absolute neutrophil count <1000 per microliter [μL]) and subjects receiving immunosuppressive therapy, including corticosteroid therapy (>40 mg per day prednisolone or equivalent for >1 week, >=20 mg per day prednisolone or equivalent for >2 weeks, or prednisolone or equivalent >=10 mg per day for >6 weeks). Subjects with a known cluster of differentiation 4 (CD4) count of <200 cells per cubic millimeter (cells/mm^3) should not be enrolled.
  • Subject has a medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as, poorly controlled asthma or chronic obstructive pulmonary disease at the Baseline Visit 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 subject has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study treatment (For example., ileostomy or malabsorption syndrome).
  • Subject 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).
  • Subject in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
  • Subject has a serious underlying disease that could be imminently life threatening, or the subject is unlikely to survive for the duration of the study period.
  • Subject has congenital long QT syndrome or known prolongation of corrected QT interval (QTc).
  • Subject has uncompensated heart failure.
  • Subject has severe left ventricular hypertrophy.
  • Subject has a family history of QT prolongation or sudden death.
  • Subject has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or bradyarrhythmia within the last 12 months.
  • The subject 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 subject is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor or a strong P-glycoprotein (P-gp) inhibitor.
  • For any subject >=12 to <18 years, the subject has an abnormal electrocardiogram (ECG) reading.
  • The subject has a QTc >450 millisecond (msec) or a QTc >480 msec for subjects with bundle-branch block.
  • Subject has a documented or recent history of uncorrected hypokalemia within the past 3 months.
  • Subject has a known history of cholestatic jaundice or hepatic dysfunction associated with prior use of azithromycin.
  • Subject has a known alanine aminotransferase (ALT) value >2 times upper limit of normal (ULN).
  • Subject 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%).
  • Subject 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).
  • Subject has been previously enrolled in this study or has previously been treated with Gepotidacin.
  • Subject has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.
  • Subject 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.
  • Subject has received any antibacterial therapy for the treatment of a gonococcal infection within 14 days before the Baseline Visit.
  • Subject has received any systemic, topical, or intravaginal antibiotics or any systemic antifungals within 7 days before the Baseline Visit.
  • Subject must not use St John's wort or ergot derivatives from within 14 days before the Baseline Visit through the TOC Visit.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010539


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04010539    
Other Study ID Numbers: 116577
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: December 28, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Urogenital Gonorrhea, Gepotidacin, Neisseria gonorrhoeae, Efficacy, Phase 3
Additional relevant MeSH terms:
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Gonorrhea
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Sexually Transmitted Diseases, Bacterial
 Sexually Transmitted Diseases
Communicable Diseases
Azithromycin
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents