Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection
NCT ID: NCT03555526
Last Updated: 2018-06-13
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
320 participants
INTERVENTIONAL
2017-12-15
2021-12-31
Brief Summary
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Hypothesis:The investigators hypothesized that genotypic resistance guided sequential therapy is non-inferior to empiric therapy in the third line treatment for refractory H. pylori infection.
Methods: This multicenter, open label, parallel group, randomized trial will be conducted since 2017.07.20. Adult (≥20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled. Genotypic and phenotypic resistances will be determined in patients who failed from at least two eradication therapies by polymerase-chain-reaction with direct sequencing and E-test and agar dilution test, respectively. Eligible patients will be randomized into either one of the treatment groups (A) genotypic resistance guided therapy; or (B) susceptibility testing guided therapy.
Outcome Measurement The primary outcome is the eradication rate in the third line treatment (genotypic versus susceptibility testing guided therapy) according to intention-to-treat (ITT) analysis.
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Detailed Description
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Hypothesis:The investigators hypothesized that genotypic resistance guided sequential therapy is non-inferior to empiric therapy in the third line treatment for refractory H. pylori infection.
Methods: This multicenter, open label, parallel group, randomized trial will be conducted since 2017.07.20. Adult (≥20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled. Genotypic and phenotypic resistances will be determined in patients who failed from at least two eradication therapies by polymerase-chain-reaction with direct sequencing and E-test and agar dilution test, respectively. Eligible patients will be randomized into either one of the treatment groups (A) genotypic resistance guided therapy; or (B) susceptibility testing guided therapy. Eradication status will be determined by 13C-urea breath test at least 6 weeks after eradication therapy. The stool samples will be collected before, and 2 and 8 weeks and 1 year after eradication therapy to analyze the changes in the antibiotic resistance and microbiota of gut flora. The body weight, waist and hip circumference and serum lipid profile, sugar, and HbA1C levels will also be collected before and 2 weeks, 8 weeks and 1 year after eradication therapy.
Outcome Measurement The primary outcome is the eradication rate in the third line treatment (genotypic versus susceptibility testing guided therapy) according to intention-to-treat (ITT) analysis.
Secondary End Points: the eradication rate according per protocol analysis and the adverse effects
Secondary End Point:
(A) Eradication rate according to per protocol analysis (PP analysis) (B) Frequency of adverse effects (C) The changes in the gut microbiota, antibiotic resistance of the Enterobacteriae, metabolic parameters before and after H. pylori eradication (D) The long term eradication rate and reinfection rate
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Genotypic resistance guided therapy
The regimen will be chosen according to the genotyping of 23S rRNA and gyrase A of H. pylori. In the absence of gyrase A mutation, esomeprazole (Nexium), amoxicillin (Amoxicillin), levofloxacin (Cravit), metronidazole (Flagyl) for 14 days will be given. In the presence of gyrase A mutation but in the absence of 23S rRNA mutation, esomeprazole (Nexium), amoxicillin (Amoxicillin), clarithromycin (Klaricid), metronidazole (Flagyl) for 14 days will be given. In the presence of both gyrase A and 23S rRNA mutation, bismuth quadruple therapy including esomeprazole (Nexium), bismuth (KCB), tetracycline, and metronidazole (Flagyl) for 10 days will be given.
Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 14 days
Amoxicillin
amoxicillin, 1000mg, bid, for 7 days (day 1-day 7)
metronidazole
metronidazole, 500mg, bid, for 7 days (day 8-14)
Levofloxacin 500mg
levofloxacin 250mg, bid, for 7 days (day 8-14)
Clarithromycin ER
clarithromycin 500mg, bid, for 7 days (day 8-14)
Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 10 days
Dibismuth trioxide
Dibismuth trioxide，KCB F.C. TABLETS，300mg，qid, for 10 days
metronidazole
metronidazole, 500mg, tid, for 10 days (day 1-10)
tetracycline
tetracycline 500mg, qid, for 10 days
Phenotypic resistance guided therapy
The regimen will be chosen according to the susceptibility testing result. In the absence of levofloxacin resistance, esomeprazole (Nexium), amoxicillin (Amoxicillin), levofloxacin (Cravit), metronidazole (Flagyl) for 14 days will be given. In the presence of levofloxacin resistance but in the absence of clarithromycin resistance, esomeprazole (Nexium), amoxicillin (Amoxicillin), clarithromycin (Klaricid), metronidazole (Flagyl) for 14 days will be given. In the presence of both levofloxacin and clarithromycin resistance, bismuth quadruple therapy including esomeprazole (Nexium), bismuth (KCB), tetracycline, and metronidazole (Flagyl) for 10 days will be given.
Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 14 days
Amoxicillin
amoxicillin, 1000mg, bid, for 7 days (day 1-day 7)
metronidazole
metronidazole, 500mg, bid, for 7 days (day 8-14)
Levofloxacin 500mg
levofloxacin 250mg, bid, for 7 days (day 8-14)
Clarithromycin ER
clarithromycin 500mg, bid, for 7 days (day 8-14)
Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 10 days
Dibismuth trioxide
Dibismuth trioxide，KCB F.C. TABLETS，300mg，qid, for 10 days
metronidazole
metronidazole, 500mg, tid, for 10 days (day 1-10)
tetracycline
tetracycline 500mg, qid, for 10 days
Interventions
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Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 14 days
Amoxicillin
amoxicillin, 1000mg, bid, for 7 days (day 1-day 7)
metronidazole
metronidazole, 500mg, bid, for 7 days (day 8-14)
Levofloxacin 500mg
levofloxacin 250mg, bid, for 7 days (day 8-14)
Clarithromycin ER
clarithromycin 500mg, bid, for 7 days (day 8-14)
Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 10 days
Dibismuth trioxide
Dibismuth trioxide，KCB F.C. TABLETS，300mg，qid, for 10 days
metronidazole
metronidazole, 500mg, tid, for 10 days (day 1-10)
tetracycline
tetracycline 500mg, qid, for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 20 years or greater
* willingness to receive rescue therapy
Exclusion Criteria
* history of gastric resection surgery
* history of allergy to study drugs
* pregnancy or lactating women
* severe underlying illness, such as end stage renal disease, decompensated liver cirrhosis, or non-curative malignancy
20 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jyh-Ming Liou, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital (recruiting)
Yen-Nien Chen, MD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital Hsin-Chu Branch
Yu Jen Fang, MD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital, Yun-Lin Branch
Locations
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Jyh-Ming Liou
Taipei, Taiwan, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Chen MJ, Chen PY, Fang YJ, Bair MJ, Chen CC, Chen CC, Yang TH, Lee JY, Yu CC, Kuo CC, Chiu MC, Chou CK, Chen CY, Hu WH, Tsai MH, Hsu YC, Shun CT, Luo JC, Lin JT, El-Omar EM, Wu MS, Liou JM; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Molecular testing-guided therapy versus susceptibility testing-guided therapy in first-line and third-line Helicobacter pylori eradication: two multicentre, open-label, randomised controlled, non-inferiority trials. Lancet Gastroenterol Hepatol. 2023 Jul;8(7):623-634. doi: 10.1016/S2468-1253(23)00097-3. Epub 2023 May 10.
Other Identifiers
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201706037MINC
Identifier Type: -
Identifier Source: org_study_id
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