NCT05874544

Brief Summary

Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2023

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

September 15, 2025

Status Verified

October 1, 2024

Enrollment Period

1.7 years

First QC Date

May 16, 2023

Last Update Submit

September 12, 2025

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylorirescue therapy

Outcome Measures

Primary Outcomes (1)

  • Helicobacter pylori eradication rate

    Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

    Six weeks after completion of therapy

Secondary Outcomes (2)

  • Rate of adverse effects

    Within 7 days after completion of therapy

  • Compliance rate

    Within 7 days after completion of therapy

Study Arms (3)

Tetracycline Bismuth Quadruple Therapy

ACTIVE COMPARATOR

Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid

Drug: VonoprazanDrug: Bismuth Potassium CitrateDrug: TetracyclineDrug: Metronidazole

Rifabutin Triple Therapy

EXPERIMENTAL

Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid

Drug: VonoprazanDrug: AmoxicillinDrug: Rifabutin

Dual Therapy

EXPERIMENTAL

Vonoprazan 20mg bid, amoxicillin 1000mg tid

Drug: VonoprazanDrug: Amoxicillin

Interventions

VonoprazanDRUG

Proton pump inhibitor

Dual TherapyRifabutin Triple TherapyTetracycline Bismuth Quadruple Therapy
Bismuth Potassium CitrateDRUG

Gastric mucosal protective drug with anti-H. pylori effect

Tetracycline Bismuth Quadruple Therapy
TetracyclineDRUG

Antibiotics for H. pylori eradication

Tetracycline Bismuth Quadruple Therapy
MetronidazoleDRUG

Antibiotics for H. pylori eradication

Tetracycline Bismuth Quadruple Therapy
AmoxicillinDRUG

Antibiotics for H. pylori eradication

Dual TherapyRifabutin Triple Therapy
RifabutinDRUG

Antibiotics for H. pylori eradication

Rifabutin Triple Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability and willingness to participate in the study and to sign and give informed consent
  • Confirmed H. pylori infection and with previous treatment experience

You may not qualify if:

  • subjects naive to H. pylori treatment,
  • under 18 or over 80 years old
  • history of gastrectomy
  • pregnant or lactating women
  • Previous history of tuberculosis
  • Allergy to any of the study drugs
  • severe systemic diseases or malignancy
  • administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

Shanghai Songjiang District Central Hospital

Shanghai, Shanghai Municipality, China

Location

The Second Affiliated Hospital of Zhejiang University school of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamineTetracyclineMetronidazoleAmoxicillinRifabutin

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingRifamycinsHeterocyclic Compounds, 4 or More RingsLactams, MacrocyclicMacrocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

May 16, 2023

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

September 15, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)