Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients

Clarithromycin-, Metronidazole-, or Levofloxacin-containing Therapy for Helicobacter Pylori-infected Penicillin-allergic Patients: A Randomized Controlled Trial

This randomized controlled clinical trial will compare the eradication efficacy of bismuth quadruple therapy containing clarithromycin+metronidazole, clarithromycin+levofloxacin, or metronidazole+levofloxacin for Helicobacter pylori first-line treatment in penicillin-allergic patients. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Clarithromycin; Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Metronidazole; Drug: Levofloxacin

• Study Type: Interventional
• Enrollment (Anticipated): 504
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
• 18-75 years old on the day of signing the ICF.
• Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
• Have not received Helicobacter pylori eradication treatment before.
• allergic to penicillin.

Exclusion Criteria:

• Have received Hp eradication treatment.
• Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
• Subjects or guardians refused to participate in the trial.
• Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
• Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
• Pregnant or lactating women.
• Active peptic ulcer.
• allergic to drugs used in the trial.
• any other circumstances that are not suitable for recruitment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CL group; Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levoflaxacin 0.5 g qd for 14 days	Drug: Clarithromycin; 0.5g bid; Drug: Rabeprazole; 20mg bid; Drug: Bismuth potassium citrate; 0.6g bid; Drug: Levofloxacin; 0.5g qd
EXPERIMENTAL: LM group; Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levoflaxacin 0.5 g bid for 14 days	Drug: Rabeprazole; 20mg bid; Drug: Bismuth potassium citrate; 0.6g bid; Drug: Metronidazole; 0.4g qid; Drug: Levofloxacin; 0.5g qd
ACTIVE_COMPARATOR: CM group; Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days	Drug: Clarithromycin; 0.5g bid; Drug: Rabeprazole; 20mg bid; Drug: Bismuth potassium citrate; 0.6g bid; Drug: Metronidazole; 0.4g qid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate of Helicobacter pylori	Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).	At least 4 weeks after completion of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate of Helicobacter pylori resistant strains	Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.	At least 4 weeks after completion of therapy
Eradication rate of Helicobacter pylori susceptible strains	Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.	At least 4 weeks after completion of therapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence rate	Adherence was defined as poor when subjects took less than 80% of the total medication.	2 weeks during therapy
Frequency of adverse events	Any possible adverse events during the 14-day treatment period were recorded.	2 weeks during therapy

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 26, 2021
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: August 14, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (ACTUAL): August 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 12, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Natriuretic Agents; Anti-Bacterial Agents; Diuretics; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Respiratory System Agents; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Expectorants; Antacids; Anti-Infective Agents, Urinary; Renal Agents; Metronidazole; Rabeprazole; Clarithromycin; Levofloxacin; Ofloxacin; Bismuth; Potassium Citrate
• Other Study ID Numbers: B2021-3762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available from the principal investigator Taotao Liu at liu.taotao@zs-hospital.sh.cn, beginning 6 months and ending 5 years after the trial results were published. The study protocol and statistical analysis plan are available online from https://clinicaltrials.gov/. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
• IPD Sharing Time Frame: Beginning 6 months and ending 5 years after the trial results were published.
• IPD Sharing Access Criteria: All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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