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En studie i pediatriske deltakere i alderen ≥2 til <12 år med mistenkt eller bekreftet bakteriell infeksjon eller som får profylaktiske antibiotika

25. september 2026 oppdatert av: GlaxoSmithKline

Fase 1, åpen merket, enarms (ikke-komparator) studie for å evaluere farmakokinetikken og sikkerheten av en enkeltdose oral gepotidacin i tillegg til standard antibiotikabehandling hos pediatriske deltakere fra 2 til under 12 år med mistenkt eller bekreftet bakteriell infeksjon eller som mottar profylakse med antibiotika

The study will be conducted to evaluate how a single oral dose of Gepotidacin is processed in the body over time along with safety monitoring in hospitalized pediatric participants who are receiving a standard of care treatment with antibacterials for a confirmed or suspected infection or for its prevention.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

25

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • California
      • Orange, California, Forente stater, 92868
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Antonio Arrieta
    • Louisiana
      • Shreveport, Louisiana, Forente stater, 71101
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Patricia Pichilingue-Reto
    • Maryland
      • Baltimore, Maryland, Forente stater, 21827
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Allison Agwu
    • Missouri
      • St Louis, Missouri, Forente stater, 63110-1010
        • GSK Investigational Site
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • David Hunstad

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

2 år til 11 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Participants having ≥2 to <12 years of age at the time of signing the informed consent/assent and have a body weight >=10 kilograms (kg).
  • Participants receiving SoC antibacterial therapy for a confirmed/suspected infection or for prophylaxis AND is able to take a single dose of the powder for oral suspension formulation of gepotidacin after a meal.
  • Participants either hospitalized or in an overnight clinic. Participant is expected to be in hospital/clinic for at least 24 hours post administration of study intervention.

Participant has an indwelling venous catheter in place as part of the clinical SoC.

  • Male or female according to their reproductive organs at birth.
  • Pregnancy testing is required as appropriate for the age, sexual activity, and sexual maturity of pediatric participants and as required by local regulations. Investigator should apply clinical judgment.
  • A female participant is eligible to participate if she is a WOCBP who is not pregnant as confirmed by a high sensitivity serum or urine pregnancy test at baseline (Day 1) regardless of current or prior contraception use or abstinence, is not breastfeeding, or is not a WOCBP.
  • Participant LAR(s) who has the ability to understand, agree to, and sign the informed consent form before initiation of any protocol-related procedures; participant has the ability to give documented assent.
  • Participant and participant's LAR are willing and able to comply with study instructions, study visits, and procedures.

Exclusion Criteria:

  • Participants having a BMI-for-age that is less than the 5th percentile or greater than the 95th percentile based on the CDC percentiles [CDC NCHS Growth Charts].

  • Participants having a clinically significant medical history, including malignancy, significant chromosome abnormality, neurological disorder or history of seizure (excluding simple febrile seizure), chronic immunosuppressive disease, active tuberculosis or acute hepatitis.

  • Participants with serious disease/condition that could be imminently life-threatening (e.g. is clinically/hemodynamically unstable, is septicemic, has severe sepsis, organ failure, requiring ITU care or has clinical laboratory tests either nonstable or anticipated to be nonstable) or the participant is unlikely to survive for the duration of the study period.

  • The participant has severe renal organ dysfunction or has known anuria, oliguria, or significant impairment of renal function (creatinine clearance <60 mL/min or clinically significant elevated serum creatinine as determined by the investigator).

  • The participant has a significant CV history or based on investigator judgment any clinically significant abnormal ECG reading at Screening/baseline (e.g., prolonged QT syndrome).

  • The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of complications (e.g., uncontrolled diabetes in the judgment of the investigator, transplant recipients (with the exception of cornea and autologous BMT), participants with clinically significant persistent granulocytopenia [absolute neutrophil count <1000/μL], and participants receiving immunosuppressive therapy, including corticosteroid therapy at a dose of >1 mg/kg/day of prednisolone or equivalent for >1 week or 0.5-<1 mg/kg/day prednisolone or equivalent for >2 weeks). Participants aged ≥6 years with a known CD4 count of <200 cells/mm3 and participants aged <6 years with a known CD4 count of <500 cells/mm3 are to not be enrolled.

  • The participant has any of the following medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as:

    • Poorly controlled asthma or obstructive pulmonary disease at baseline and, in the opinion of the investigator, not stable on current therapy.
    • Active peptic ulcer disease
    • Juvenile Parkinson disease
    • Juvenile Myasthenia gravis

  • The participant has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention (e.g., ileostomy or malabsorption syndrome).

  • The participant plans to use any of the prohibited medications or nondrug therapies from the Baseline Visit through Follow-up Visit at 7 ±3 days after the single dose of study intervention.

  • The participant has received a prohibited medication within 14 days or 5 half-lives prior to gepotidacin administration, whichever is longer.

  • The participant has been previously enrolled in this study or has previously been treated with gepotidacin.

  • The participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives prior to gepotidacin administration, whichever is longer.

  • The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.

  • If the child is being breastfed:

    • There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother.
    • The breastfeeding mother is taking any medication or any substances containing any of the medications included in the prohibited medication list with known or unknown lactation excretion.

  • The participant has severe hepatic organ dysfunction.

  • The participant has an ALT value >2 × ULN.

  • The participant has a total bilirubin >1.5xULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5xULN as long as direct bilirubin is ≤1.5xULN.

  • Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.

  • The participant has congenital long QT syndrome or known prolongation of the QTc interval.

  • The participant has uncompensated heart failure.

  • The participant has severe left ventricular hypertrophy.

  • The participant has a family history of QT prolongation or sudden death or history of sudden infant death in a sibling.

  • The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months.

  • The participant is taking QT-prolonging drugs or drugs known to increase the risk of TdP per the ww.crediblemeds.org. "Known Risk of TdP" category at the time of the Baseline Visit, which cannot be safely discontinued from the Baseline Visit (Day 1) through 7 (+3) days after the single dose of study intervention; or the participant is taking a strong CYP3A4 inhibitor.

  • The participant has a mean triplicate QTc >450 msec or a mean triplicate QTc >480 msec for participants with complete bundle branch block.

  • The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Gepotidacin plus Standard of care (SOC)

Single Arm
Legemiddel: Gepotidacin

Gepotidacin will be administered

Legemiddel: SOC

SOC will be administered

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
AUC fra tid null til tiden for den siste kvantifiserbare konsentrasjonen (AUC[0-t]) av gepotidacin
Tidsramme: Opptil 24 timer etter dose (Dag 1)
Opptil 24 timer etter dose (Dag 1)
Areal under konsentrasjonstidskurven fra tid null ekstrapolert til uendelig tid (AUC[0-inf]) for gepotidacin
Tidsramme: Opptil 24 timer etter dose (Dag 1)
Opptil 24 timer etter dose (Dag 1)
Maksimal observert plasmakonsentrasjon (Cmax) av gepotidacin
Tidsramme: Opptil 24 timer etter dose (dag 1)
Opptil 24 timer etter dose (dag 1)
Tilsynelatende oral klaring (CL/F) av gepotidacin
Tidsramme: Opptil 24 timer etter dose (dag 1)
Opptil 24 timer etter dose (dag 1)
Tilsynelatende distribusjonsvolum (Vz/F) for gepotidacin
Tidsramme: Opptil 24 timer etter dose (dag 1)
Opptil 24 timer etter dose (dag 1)
Terminalfase halveringstid (t1/2) for gepotidacin
Tidsramme: Opp til 24 timer etter dose (dag 1)
Opp til 24 timer etter dose (dag 1)

Sekundære resultatmål

Resultatmål
Tidsramme
Antall deltakere med bivirkninger (AEs), spesielle bivirkninger av interesse (AESI) og alvorlige bivirkninger (SAEs)
Tidsramme: Opptil 7 dager (±3 dager)
Opptil 7 dager (±3 dager)
Endring fra utgangspunkt i vitale tegn: Temperatur
Tidsramme: 2 timer (±15 minutter) etter dose på dag 1
2 timer (±15 minutter) etter dose på dag 1
Endring fra baseline i vitale tegn: Blodtrykk
Tidsramme: 2 timer (±15 minutter) etter dosering på dag 1
2 timer (±15 minutter) etter dosering på dag 1
Endring fra baseline i vitale tegn: Pulsfrekvens
Tidsramme: 2 timer (±15 minutter) etter dosering på dag 1
2 timer (±15 minutter) etter dosering på dag 1
Endring fra baseline i elektrokardiogram (EKG)
Tidsramme: Etter 2 timer (±15 minutter) etter dosering på dag 1
Etter 2 timer (±15 minutter) etter dosering på dag 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

18. september 2026

Primær fullføring (Antatt)

23. august 2027

Studiet fullført (Antatt)

23. august 2027

Datoer for studieregistrering

Først innsendt

19. januar 2026

Først innsendt som oppfylte QC-kriteriene

19. januar 2026

Først lagt ut (Faktiske)

28. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 222778
  • 2025-522916-17 (EudraCT-nummer)
  • 2025 (U.S. NIH-stipend/kontrakt)
  • HSSO100201300011C (Annen identifikator: BARDA Agreement number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

IPD-delingstidsramme

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 asset(s) with development terminated across all indications.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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