Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients
NCT ID: NCT05023577
Last Updated: 2021-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
504 participants
INTERVENTIONAL
2021-08-26
2022-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Rabeprazole
20mg bid
Bismuth potassium citrate
0.6g bid
Clarithromycin
0.5g bid
Levofloxacin
0.5g qd
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
Rabeprazole
20mg bid
Bismuth potassium citrate
0.6g bid
Metronidazole
0.4g qid
Levofloxacin
0.5g qd
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
Rabeprazole
20mg bid
Bismuth potassium citrate
0.6g bid
Metronidazole
0.4g qid
Clarithromycin
0.5g bid
Interventions
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Rabeprazole
20mg bid
Bismuth potassium citrate
0.6g bid
Metronidazole
0.4g qid
Clarithromycin
0.5g bid
Levofloxacin
0.5g qd
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Taotao Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B2021-3762
Identifier Type: -
Identifier Source: org_study_id
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