Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment
NCT ID: NCT05250050
Last Updated: 2022-03-18
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
388 participants
INTERVENTIONAL
2022-03-25
2023-03-01
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
SINGLE
Study Groups
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Genotypic resistance guided therapy
After Helicobacter pylori drug resistance mutation gene detection, according to genotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Esomeprazole
20mg bid
Bismuth potassium citrate
0.6g bid
Metronidazole
0.4g qid
Clarithromycin
0.5g bid
Levofloxacin
0.5g qd
Amoxicillin
1g bid
Tetracycline
0.5g qid
Phenotypic resistance guided therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to phenotypic antibiotic resistance pattern of each one, give esomeprazole 20mg bid and bismuth potassium citrate 0.6 g bid, combined two sensitive antibiotics of Amoxicillin, tetracycline,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Esomeprazole
20mg bid
Bismuth potassium citrate
0.6g bid
Metronidazole
0.4g qid
Clarithromycin
0.5g bid
Levofloxacin
0.5g qd
Amoxicillin
1g bid
Tetracycline
0.5g qid
Empiric therapy
Esomeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g bid (no penicillin allergy) OR tetracycline 0.5g qid (penicillin allergy) for 14 days
Esomeprazole
20mg bid
Bismuth potassium citrate
0.6g bid
Metronidazole
0.4g qid
Amoxicillin
1g bid
Tetracycline
0.5g qid
Interventions
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Esomeprazole
20mg bid
Bismuth potassium citrate
0.6g bid
Metronidazole
0.4g qid
Clarithromycin
0.5g bid
Levofloxacin
0.5g qd
Amoxicillin
1g bid
Tetracycline
0.5g qid
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.
Exclusion Criteria
* 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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Hong Gao, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Huashan 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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B2021-831
Identifier Type: -
Identifier Source: org_study_id
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