Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori

NCT06299605 | Enrolling By Invitation

• 1 other identifier: SHARE2401
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Eradication rate

  13C-urea breath test was used to determine whether eradication was successful. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in the three groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

  Immediately after follow-up check

Secondary Outcomes (2)

• Rate of adverse reactions

  Immediately after follow-up check

• Patient compliance

  Immediately after follow-up check

Study Arms (3)

14-day quadruple regimen

ACTIVE COMPARATOR

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days

Drug: Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days

14-day triple regimen

EXPERIMENTAL

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days

Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days

7-day triple regimen

EXPERIMENTAL

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days

Drug: Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days

Interventions

Vonoprazan-Amoxicillin-Tetracycline-Bismuth quadruple regimen for 14 days DRUG

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid + Bismuth 220mg bid for 14 days

Also known as: Vonoprazan, Amoxicillin, Tetracycline, Bismuth, 14 days

14-day quadruple regimen

Vonoprazan-Amoxicillin-Tetracycline triple regimen for 14 days DRUG

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 14 days

Also known as: Vonoprazan, Amoxicillin, Tetracycline, 14 days

14-day triple regimen

Vonoprazan-Amoxicillin-Tetracycline triple regimen for 7 days DRUG

Vonoprazan 20mg bid + Amoxicillin 1000mg bid + Tetracycline 500mg qid for 7 days

Also known as: Vonoprazan, Amoxicillin, Tetracycline, 7 days

7-day triple regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-70 years old;
• Patients with H.pylori infection (positive rapid urease test, 13C/14C-urea breath test);
• Patients without previous treatment for H. pylori eradication.

You may not qualify if:

• Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%;
• Patients with active gastrointestinal bleeding;
• Patients with a history of upper gastrointestinal surgery;
• Patients allergic to treatment drugs;
• Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks;
• Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial;
• Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse;
• Patients who are unwilling or incapable to provide informed consents.

Sponsors & Collaborators

• Shandong University: lead
• Binzhou Maternal and Child Health Hospital: collaborator
• Zibo Maternal and Child Health Hospital: collaborator
• Zaozhuang Municipal Hospital: collaborator
• Linyi Yizhou Hospital: collaborator
• Feicheng Municipal People's Hospital: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

Related Publications (8)

• Li Y, Choi H, Leung K, Jiang F, Graham DY, Leung WK. Global prevalence of Helicobacter pylori infection between 1980 and 2022: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023 Jun;8(6):553-564. doi: 10.1016/S2468-1253(23)00070-5. Epub 2023 Apr 20.

  PMID: 37086739 BACKGROUND

• Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available.

  PMID: 30893536 BACKGROUND

• Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 8:gutjnl-2022-327745. doi: 10.1136/gutjnl-2022-327745. Online ahead of print.

  PMID: 35944925 BACKGROUND

• Lin K, Huang L, Wang Y, Li K, Ye Y, Yang S, Li A. Efficacy of genotypic susceptibility-guided tailored therapy for Helicobacter pylori infection: A systematic review and single arm meta-analysis. Helicobacter. 2023 Dec;28(6):e13015. doi: 10.1111/hel.13015. Epub 2023 Aug 27.

  PMID: 37634236 BACKGROUND

• Savoldi A, Carrara E, Graham DY, Conti M, Tacconelli E. Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in World Health Organization Regions. Gastroenterology. 2018 Nov;155(5):1372-1382.e17. doi: 10.1053/j.gastro.2018.07.007. Epub 2018 Jul 7.

  PMID: 29990487 BACKGROUND

• Jiang Z, Qian X, Wang Z, Dong Y, Pan Y, Zhang Z, Wang S. Antibiotic resistance of Helicobacter pylori isolated from patients in Nanjing, China: A cross-section study from 2018 to 2021. Front Cell Infect Microbiol. 2022 Sep 8;12:970630. doi: 10.3389/fcimb.2022.970630. eCollection 2022.

  PMID: 36159644 BACKGROUND

• Chey WD, Megraud F, Laine L, Lopez LJ, Hunt BJ, Howden CW. Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology. 2022 Sep;163(3):608-619. doi: 10.1053/j.gastro.2022.05.055. Epub 2022 Jun 6.

  PMID: 35679950 BACKGROUND

• Xie Y, Hu Y, Zhu Y, Wang H, Wang QZ, Li YQ, Wang JB, Zhang ZY, Zhang DK, Liu XW, Lu NH. Colloidal bismuth pectin-containing quadruple therapy as the first-line treatment of Helicobacter pylori infection: A multicenter, randomized, double-blind, non-inferiority clinical trial. Helicobacter. 2023 Jun;28(3):e12978. doi: 10.1111/hel.12978. Epub 2023 Mar 31.

  PMID: 37002653 BACKGROUND

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin; Tetracycline; Bismuth

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 8, 2024
• Study Start: November 27, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 30, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)