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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05023577

Collaborator

(none)

504

Enrollment

Location

Arms

16.1

Anticipated Duration (Months)

31.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Rabeprazole Drug: Bismuth potassium citrate Drug: Metronidazole Drug: Clarithromycin Drug: Levofloxacin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

504 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 26, 2021

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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: Rabeprazole 20mg bid Drug: Bismuth potassium citrate 0.6g bid Drug: Clarithromycin 0.5g 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: Rabeprazole 20mg bid Drug: Bismuth potassium citrate 0.6g bid Drug: Metronidazole 0.4g qid Drug: Clarithromycin 0.5g bid

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: Rabeprazole

20mg bid

Drug: Bismuth potassium citrate

0.6g bid

Drug: Clarithromycin

0.5g 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: Rabeprazole

20mg bid

Drug: Bismuth potassium citrate

0.6g bid

Drug: Metronidazole

0.4g qid

Drug: Clarithromycin

0.5g bid

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Eradication rate of Helicobacter pylori resistant strains [At least 4 weeks after completion of therapy]
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.
Eradication rate of Helicobacter pylori susceptible strains [At least 4 weeks after completion of therapy]
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.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.