Rescue Therapy for Helicobacter Pylori Eradication

Rescue Therapy for Helicobacter Pylori Eradication: A Randomized Non-Inferiority Trial of Minocycline or Tetracycline in Bismuth Quadruple Therapy

Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Tetracycline,Metronidazole; Drug: Minocycline,Metronidazole

• Study Type: Interventional
• Enrollment (Actual): 368
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital, Tongji University School of Medicine
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tetracycline Bismuth Quadruple Therapy; Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid	Drug: Esomeprazole; Proton pump inhibitor; Drug: Bismuth Potassium Citrate; Gastric mucosal protective drug with anti-H. pylori effect; Drug: Tetracycline,Metronidazole; Antibiotics for H. pylori eradication
Experimental: Minocycline Bismuth Quadruple Therapy; Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid	Drug: Esomeprazole; Proton pump inhibitor; Drug: Bismuth Potassium Citrate; Gastric mucosal protective drug with anti-H. pylori effect; Drug: Minocycline,Metronidazole; Antibiotics for H. pylori eradication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse effects	The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)	Within 7 days after completion of therapy
Compliance rate	Compliance was defined as poor when they had taken less than 80% of the total medication	Within 7 days after completion of therapy

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Helicobacter pylori; minocycline; rescue therapy; tetracycline
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Natriuretic Agents; Anti-Bacterial Agents; Diuretics; Protein Synthesis Inhibitors; Respiratory System Agents; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Expectorants; Antacids; Metronidazole; Esomeprazole; Bismuth; Tetracycline; Potassium Citrate; Minocycline
• Other Study ID Numbers: rjkls2019013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No