Vonoprazan High-Dose Dual VS Levofloxacin Concomitant
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Damascus, Syrië
- General Assembly of Damascus Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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).
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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.
Andere namen:
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Experimenteel: levofloxacin concomitant
(levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks).
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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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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H. pylori Eradication Rate
Tijdsspanne: two weeks/14 days
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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.
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two weeks/14 days
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Darmziekten
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Gastro-enteritis
- Ziekten van de twaalfvingerige darm
- Gastritis
- Maagzweer
- Zwavelverbindingen
- Organische chemicaliën
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Heterocyclische verbindingen, 2-ring
- Heterocyclische verbindingen, gefuseerd ring
- Azoles
- Imidazolen
- Amides
- Penicilline g
- bèta-lactams
- Lactams
- Fluorochinolonen
- 4-quinolonen
- Chinolonen
- Chinolines
- Ofloxacine
- Nitroimidazolen
- Nitroverbindingen
- Ampicilline
- Penicillines
- Amoxicilline
- Levofloxacine
- Tinidazol
- 1- (5- (2-fluorofenyl) -1- (pyridine-3-ylsulfonyl) -1H-Pyrrol-3-yl) -n-methylmethanamine
Andere studie-ID-nummers
- D202660
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
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