14-day Susceptibility-guided Bismuth Quadruple Therapy for Multiple Drug Resistant H. Pylori Infection

NCT06687499 | Completed Phase 4

• 1 other identifier: B-BR-111-042
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the 14-day susceptibility-guided bismuth quadruple therapy works to treat multiple drug resistant Helicobacter pylori (H. pylori) in adults. It will also learn about the adverse effects of bismuth quadruple therapy. The main questions it aims to answer are:

• Does 14-day susceptibility-guided bismuth quadruple therapy higher the eradication rate?
• What medical problems do participants have when taking 14-day susceptibility-guided bismuth quadruple? Researchers will record 14-day susceptibility-guided bismuth quadruple to see if 14-day susceptibility-guided bismuth quadruple works to treat multiple drug resistant H. pylori. Participants will:
• Take susceptibility-guided bismuth quadruple every day for 14 days
• Visit the clinic once 4-6 weeks for checkups and tests
• Keep a diary of their symptoms during taking susceptibility-guided bismuth quadruple

Conditions

Helicobacter Pylori; Drug Resistance, Multiple

Keywords

bismuth; microbial sensitivity tests; Helicobacter pylori; drug resistance, multiple

Outcome Measures

Primary Outcomes (1)

• The eradication rate of H. pylori

  The investigators define successful eradication as a negative 13C-urea breath test or a negative H. pylori stool antigen test at 4 to 6 weeks after the completion of H. pylori eradication and discontinuation of antibiotics and proton pump inhibitors. The eradication rates are determined by intention-to-treat and per-protocol analyses. The intention-to-treat analysis evaluates all enrolled participants. The per-protocol analysis evaluates those who take \>= 80% of the study medications and receive post-treatment 13C-urea breath test or an H. pylori stool antigen test. The successful rate is represented with a percentage (%).

  From enrollment to the end of treatment at 6-8 weeks

Secondary Outcomes (2)

• Adverse effects

  From enrollment to the end of treatment at 2 weeks

• Adherence to medications

  From enrollment to the end of treatment at 2 weeks

Other Outcomes (4)

• The sex-based eradication rate of H. pylori

  From enrollment to the end of treatment at 6-8 weeks

• The regimen-based eradication rate of H. pylori

  From enrollment to the end of treatment at 6-8 weeks

• The resistance-number-based eradication rate of H. pylori

  From enrollment to the end of treatment at 6-8 weeks

Study Arms (1)

Bismuth-based susceptibility-guided treatment

EXPERIMENTAL

Participants who have triple- or quadruple-drug resistant H. pylori infection are enrolled. Participants receive one of the four regimens based on susceptibility test.

Drug: Bismuth-based susceptibility-guided treatment

Interventions

Bismuth-based susceptibility-guided treatment DRUG

The investigators design four regimes for H. pylori eradication and participants receive one of the regimens based on susceptibility test. The four regimens are PBAT for those with both amoxicillin and tetracycline susceptible H. pylori; PBAM for those with amoxicillin susceptible but tetracycline resistant H. pylori; PBMT for those with amoxicillin resistant but tetracycline susceptible H. pylori; PBMR for those with both amoxicillin and tetracycline resistant H. pylori. A is amoxicillin (1000 mg thrice daily), B is colloidal bismuth subcitrate (120 mg thrice daily), M is metronidazole (500 mg thrice daily), P is a proton pump inhibitor, i.e., esomeprazole (40 mg twice daily), R is rifabutin (150 mg twice daily), and T is tetracycline (500 mg thrice daily). The treatment duration is 14 days for all regimens.

Bismuth-based susceptibility-guided treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• H. pylori-infected with treatment experience with at least one course of eradication failure
• H. pylori-infected with treatment naïve but having multiple-drug resistant H. pylori (\>= three antibiotics)
• H. pylori infection confirmed by H. pylori culture

You may not qualify if:

• Previous allergic reactions to regimens, including amoxicillin, bismuth subcitrate, esomeprazole, metronidazole, rifabutin, and tetracycline,
• Severe comorbidities,
• Chronic kidney disease with estimated glomerular filtration rate \< 60 ml/min/1.73 m2,
• Pregnant or breastfeeding women.
• Dual-resistant H. pylori infection
• Mono-resistant H. pylori infection
• All susceptible H. pylori infection
• Positive RUT but negative H. pylori culture
• Negative RUT and negative H. pylori culture
• Decline to participate

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Ministry of Health and Welfare, Taiwan: collaborator

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan, 704302, Taiwan

Location

Related Publications (3)

• Fischbach L, Evans EL. Meta-analysis: the effect of antibiotic resistance status on the efficacy of triple and quadruple first-line therapies for Helicobacter pylori. Aliment Pharmacol Ther. 2007 Aug 1;26(3):343-57. doi: 10.1111/j.1365-2036.2007.03386.x.

  PMID: 17635369 BACKGROUND

• Marzio L, Coraggio D, Capodicasa S, Grossi L, Cappello G. Role of the preliminary susceptibility testing for initial and after failed therapy of Helicobacter pylori infection with levofloxacin, amoxicillin, and esomeprazole. Helicobacter. 2006 Aug;11(4):237-42. doi: 10.1111/j.1523-5378.2006.00407.x.

  PMID: 16882326 BACKGROUND

• Thung I, Aramin H, Vavinskaya V, Gupta S, Park JY, Crowe SE, Valasek MA. Review article: the global emergence of Helicobacter pylori antibiotic resistance. Aliment Pharmacol Ther. 2016 Feb;43(4):514-33. doi: 10.1111/apt.13497. Epub 2015 Dec 23.

  PMID: 26694080 BACKGROUND

Study Officials

• Hsiu-Chi Cheng, MD, PhD

  National Cheng-Kung University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 13, 2024
• Study Start: August 22, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 26, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)