A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)

NCT05630833 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 214144
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 27

Brief Summary

The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 \[NCT04020341\] and 212390 \[NCT04187144\]).

Conditions

Urinary Tract Infections

Keywords

Acute cystitis; Efficacy; Gepotidacin; Nitrofurantoin; Urinary Tract Infection; Japanese Female

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit

  TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.

  At TOC visit (Days 9 to 16)

Secondary Outcomes (34)

• Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population

  At TOC visit (Days 9 to 16)

• Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population

  At TOC visit (Days 9 to 16)

• Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population

  At TOC visit (Days 9 to 16)

• Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population

  At TOC visit (Days 9 to 16)

• Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population

  At TOC visit (Days 9 to 16)

Study Arms (2)

Gepotidacin + Placebo

EXPERIMENTAL

Drug: Gepotidacin; Drug: Placebo

Nitrofurantoin + Placebo

ACTIVE COMPARATOR

Drug: Nitrofurantoin; Drug: Placebo

Interventions

Gepotidacin DRUG

Gepotidacin will be administered.

Gepotidacin + Placebo

Nitrofurantoin DRUG

Nitrofurantoin will be administered.

Nitrofurantoin + Placebo

Placebo DRUG

Placebo will be administered.

Gepotidacin + Placebo; Nitrofurantoin + Placebo

Eligibility Criteria

• Age: 12 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant has a body weight \>=40 kilograms (kg).
• The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset less than (\<) 96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain.
• The participant has nitrite or pyuria (greater than \[\>\]15 white blood cell \[WBC\]/high-power field \[HPF\] or the presence of 3 plus (+) /large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures.
• The participant is capable of giving signed informed consent/assent.

You may not qualify if:

• The participant resides in a nursing home or dependent care type facility.
• The participant has a body mass index \>=40.0 kilogram per meter square (kg/m\^2) or a body mass index \>=35.0 kg/m\^2 and is experiencing obesity-related health conditions such as uncontrolled high blood pressure or uncontrolled diabetes.
• The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications.
• The participant has any of the following:
• Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain; 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
• Known acute porphyria.
• Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention.
• The participant has a known glucose-6-phosphate dehydrogenase deficiency.
• The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
• The participant has acute uncomplicated cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacterales (other than E. coli) as the contributing pathogen.
• The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments or preclude complete resolution of acute cystitis symptoms.
• The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesicoureteral reflux, detrusor insufficiency).
• The participant has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract.
• The participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptom onset \>=96 hours before study entry, or a temperature \>=38 Degrees Celsius \[°C\], flank pain, chills, or any other manifestations suggestive of upper UTI.
• The participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance \<60 milliliters per minute (mL/min) or clinically significant elevated serum creatinine as determined by the investigator).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (27)

GSK Investigational Site

Chiba, 263-0043, Japan

Location

GSK Investigational Site

Chiba, 270-0034, Japan

Location

GSK Investigational Site

Chiba, 272-0107, Japan

Location

GSK Investigational Site

Chiba, 286-0201, Japan

Location

GSK Investigational Site

Fukuoka, 810-0001, Japan

Location

GSK Investigational Site

Fukuoka, 811-0120, Japan

Location

GSK Investigational Site

Fukuoka, 814-0013, Japan

Location

GSK Investigational Site

Fukuoka, 816-0943, Japan

Location

GSK Investigational Site

Gunma, 370-0826, Japan

Location

GSK Investigational Site

Hokkaido, 006-0816, Japan

Location

GSK Investigational Site

Ibaraki, 300-0062, Japan

Location

GSK Investigational Site

Ibaraki, 305-0821, Japan

Location

GSK Investigational Site

Kagoshima, 890-0073, Japan

Location

GSK Investigational Site

Kanagawa, 231-0861, Japan

Location

GSK Investigational Site

Kanagawa, 232-0067, Japan

Location

GSK Investigational Site

Kochi, 781-0085, Japan

Location

GSK Investigational Site

Miyagi, 980-0803, Japan

Location

GSK Investigational Site

Osaka, 534-0024, Japan

Location

GSK Investigational Site

Osaka, 564-0063, Japan

Location

GSK Investigational Site

Saga, 840-0831, Japan

Location

GSK Investigational Site

Saitama, 352-0001, Japan

Location

GSK Investigational Site

Saitama, 360-0012, Japan

Location

GSK Investigational Site

Tokyo, 130-0026, Japan

Location

GSK Investigational Site

Tokyo, 162-0804, Japan

Location

GSK Investigational Site

Tokyo, 167-0051, Japan

Location

GSK Investigational Site

Tokyo, 175-0093, Japan

Location

GSK Investigational Site

Tokyo, 186-0002, Japan

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

gepotidacin; Nitrofurantoin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

GlaxoSmithKline (GSK) was informed of suspected GCP violations in a Japanese site management organization which provided site management services to one of the sites for this study, at which 6 participants were enrolled (5 gepotidacin participants; 1 nitrofurantoin participant). These 6 participants were excluded from the analysis due to data integrity issues including undeniable suspected data falsification that resulted in unreliable data.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: November 30, 2022
• Study Start: January 11, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

JP (27)