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Vonoprazan High-Dose Dual VS Levofloxacin Concomitant

1. juni 2026 opdateret af: Marouf Alhalabi, Damascus Hospital

Efficacy and Safety of Vonoprazan High-Dose Dual Therapy Compared to Levofloxacin Concomitant Therapy for H. Pylori Eradication: A Randomized Controlled Trial

This is a randomized controlled trial comparing the efficacy and safety of two vonoprazan-based regimens: high-dose dual therapy (vonoprazan plus a single antibiotic) versus triple therapy (vonoprazan plus two antibiotics) for the treatment of H. pylori infection).

Participants will be randomly assigned to receive either regimen for 14 days. The primary outcome is eradication rate , and secondary outcomes include adverse events and treatment adherence.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study Design: This is a prospective, parallel-group, randomized controlled trial.

Setting: multi-center conducted at Damascus hospital and Iben Al-Nfees Hospital

Participants: Adult patients aged [18-70] years with confirmed [condition, e.g., H. pylori infection by urea breath test or histology]. Exclusion criteria include prior [vonoprazan use / antibiotic allergy / pregnancy / significant comorbidity].

Interventions:

Group A (High-Dose Dual Therapy): Vonoprazan [20 mg BID] + [amoxicillin, 1000 mg three times for 14 days.

Group B :levofloxacin concomitant:

levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for 14 days.

Outcomes:

Primary: [Eradication rate / healing rate] assessed at [4-8 weeks post-treatment].

Secondary: Incidence of adverse events (mild, moderate, severe), treatment adherence (pill count or diary), and [other outcomes like symptom improvement or cost-effectiveness].

Sample Size: [N] participants per group to achieve [80-90%] power with alpha = 0.05.

Statistical Analysis: Intention-to-treat and per-protocol analyses. Categorical variables compared using chi-square or Fisher's exact test; continuous variables using t-test or Mann-Whitney U test. A p-value < 0.05 is considered statistically significant.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Syrien
      • Damascus, Syrien
        • General Assembly of Damascus Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 years and ≤ 80 years (adjust upper limit as needed)
  • Confirmed Helicobacter pylori infection by at least one of the following: positive urea breath test, rapid urease test, histopathology, or stool antigen test
  • Treatment-naïve for H. pylori (no prior eradication therapy) - OR - prior treatment failure (specify if rescue therapy)
  • Willing and able to provide written informed consent
  • Willing to adhere to the 14-day treatment regimen and follow-up visits
  • For women of childbearing potential: negative pregnancy test and agreement to use effective contraception during the treatment period

Exclusion Criteria:

  • History of allergy or hypersensitivity to vonoprazan, amoxicillin, clarithromycin, metronidazole, or any other penicillin/cephalosporin
  • Previous H. pylori eradication therapy (if study is for first-line treatment)
  • Active gastrointestinal bleeding or perforation
  • Severe liver disease (Child-Pugh class B or C) or severe renal impairment (eGFR < 30 mL/min/1.73m²)
  • Pregnancy or breastfeeding
  • Concurrent use of medications with significant drug-drug interactions (e.g., warfarin, phenytoin, digoxin, atazanavir, rilpivirine)
  • Malignancy or any life-threatening condition with life expectancy < 6 months
  • Participation in another interventional trial within 30 days prior to enrollment
  • Any condition that, in the investigator's opinion, precludes safe participation or adherence to the protocol

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Vonoprazan High-Dose Dual
Participants receive vonoprazan 20 mg twice daily (BID) plus amoxicillin 1 g three times daily (TID) for 14 days. Vonoprazan is taken before meals. Amoxicillin is taken at evenly spaced intervals (approximately every 8 hours).
Medicin: Vonoprazan
Oral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose adjustments permitted during the 14-day treatment period.
Andre navne:
  • PPI
  • Amoxicillin
Eksperimentel: levofloxacin concomitant
(levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks).
Medicin: Levofloxacin 500mg
Oral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose
Andre navne:
  • Amoxicillin
  • Tinidazol
  • Esomperazole

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
H. pylori Eradication Rate
Tidsramme: two weeks/14 days
Proportion of participants with negative H. pylori status confirmed by urea breath test (or stool antigen test) at least 4 weeks after completion of study treatment. Eradication is defined as a negative test result. Both intention-to-treat and per-protocol analyses will be performed.
two weeks/14 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Damascus Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D202660

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified IPD underlying published results will be shared upon reasonable request to the corresponding author, subject to a signed data access agreement.

IPD-delingstidsramme

after ending RCT

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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