Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori
1 other identifier
interventional
413
1 country
1
Brief Summary
Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
1 active site
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 6, 2021
CompletedStudy Start
First participant enrolled
May 7, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedNovember 15, 2022
November 1, 2022
1.4 years
May 6, 2021
November 10, 2022
Conditions
Keywords
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
Six weeks after completion of therapy
Secondary Outcomes (1)
Compliance rate
Within 7 days after completion of therapy
Study Arms (2)
Tetracycline Bismuth Quadruple Therapy
ACTIVE COMPARATOREsomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid
rifabutin triple therapy
EXPERIMENTALEsomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid
Interventions
Gastric mucosal protective drug with anti-H. pylori effect
Antibiotics for H. pylori eradication
Eligibility Criteria
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:
- Less than 18 years old
- With previous gastric surgery
- Previous history of tuberculosis
- Major systemic diseases
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127, China
Related Publications (1)
Chen J, Guo Y, Huang Y, Ding Z, Wang J, Liang X, Xu P, Han Y, Lu H. Rifabutin-Containing Triple Therapy Versus Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Multicenter, Randomized Controlled Trial. J Infect Dis. 2023 Aug 31;228(5):511-518. doi: 10.1093/infdis/jiad114.
PMID: 37079894DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
- Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
Study Record Dates
First Submitted
May 6, 2021
First Posted
May 10, 2021
Study Start
May 7, 2021
Primary Completion
October 14, 2022
Study Completion
October 30, 2022
Last Updated
November 15, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share