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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究場所
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Damascus、シリア
- General Assembly of Damascus Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
他の名前：
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実験的：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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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H. pylori Eradication Rate
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- D202660
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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