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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
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Damascus, Syria
- General Assembly of Damascus Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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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).
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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.
Andre navn:
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Eksperimentell: 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
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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H. pylori Eradication Rate
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Tarmsykdommer
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Magesykdommer
- Gastroenteritt
- Duodenale sykdommer
- Gastritt
- Magesår
- Svovelforbindelser
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Azoler
- Imidazoles
- Amides
- Penicillin g
- Beta-laktams
- Laktams
- Fluorokinoloner
- 4-kvinoloner
- Kinoloner
- Kinoliner
- Ofloxacin
- Nitroimidazoler
- Nitroforbindelser
- Ampicillin
- Penicillins
- Amoksicillin
- Levofloxacin
- Tinidazol
- 1- (5- (2-fluorofenyl) -1- (pyridin-3-ylsulfonyl) -1H-pyrrol-3-yl) -N-metylmetanamin
Andre studie-ID-numre
- D202660
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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