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Trial record 71 of 201 for:    TETRACYCLINE

Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03555526
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

The inviestigators aimed to compare the efficacy of genotypic resistance guided versus susceptibility testing guided therapy in the third line treatment for refractory H. pylori infection.

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.


Condition or disease Intervention/treatment Phase
H Pylori Infection Drug: Esomeprazole 40mg Drug: Amoxicillin Drug: metronidazole Drug: Levofloxacin 500mg Drug: Clarithromycin ER Drug: Dibismuth trioxide Drug: tetracycline Phase 4

Detailed Description:

The inviestigators aimed to compare the efficacy of genotypic resistance guided versus susceptibility testing guided therapy in the third line treatment for refractory H. pylori infection.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Genotypic Resistance Guided Versus Susceptibility Testing Guided Therapy for the Third-line Eradication of H. Pylori- a Multicenter Randomized Trial
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: 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.
Drug: Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 14 days
Other Name: Nexium (Sequential)

Drug: Amoxicillin
amoxicillin, 1000mg, bid, for 7 days (day 1-day 7)
Other Name: Amoxicillin (Sequential)

Drug: metronidazole
metronidazole, 500mg, bid, for 7 days (day 8-14)
Other Name: Flagyl (sequential)

Drug: Levofloxacin 500mg
levofloxacin 250mg, bid, for 7 days (day 8-14)
Other Name: Cravit (sequential)

Drug: Clarithromycin ER
clarithromycin 500mg, bid, for 7 days (day 8-14)
Other Name: Klaricid ER 500 (sequential)

Drug: Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 10 days
Other Name: Nexium (bismuth quadruple therapy)

Drug: Dibismuth trioxide
Dibismuth trioxide,KCB F.C. TABLETS,300mg,qid, for 10 days
Other Names:
  • KCB F.C.
  • bismuth

Drug: metronidazole
metronidazole, 500mg, tid, for 10 days (day 1-10)
Other Name: Flagyl (bismuth quadruple)

Drug: tetracycline
tetracycline 500mg, qid, for 10 days
Other Name: tetracycline (bismuth quadruple therapy)

Active Comparator: 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.
Drug: Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 14 days
Other Name: Nexium (Sequential)

Drug: Amoxicillin
amoxicillin, 1000mg, bid, for 7 days (day 1-day 7)
Other Name: Amoxicillin (Sequential)

Drug: metronidazole
metronidazole, 500mg, bid, for 7 days (day 8-14)
Other Name: Flagyl (sequential)

Drug: Levofloxacin 500mg
levofloxacin 250mg, bid, for 7 days (day 8-14)
Other Name: Cravit (sequential)

Drug: Clarithromycin ER
clarithromycin 500mg, bid, for 7 days (day 8-14)
Other Name: Klaricid ER 500 (sequential)

Drug: Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 10 days
Other Name: Nexium (bismuth quadruple therapy)

Drug: Dibismuth trioxide
Dibismuth trioxide,KCB F.C. TABLETS,300mg,qid, for 10 days
Other Names:
  • KCB F.C.
  • bismuth

Drug: metronidazole
metronidazole, 500mg, tid, for 10 days (day 1-10)
Other Name: Flagyl (bismuth quadruple)

Drug: tetracycline
tetracycline 500mg, qid, for 10 days
Other Name: tetracycline (bismuth quadruple therapy)




Primary Outcome Measures :
  1. Eradication rate by intention to treat analysis [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Eradication rate by per protocol analysis [ Time Frame: 8 weeks ]
  2. frequency of adverse effects during eradication therapy [ Time Frame: 2 weeks ]
  3. changes of fecal microbiota [ Time Frame: 1 year ]
    changes of fecal microbiota before and after erdication therapy

  4. reinfection rate [ Time Frame: 1 year ]
    reinfection rate 1 year after eradication therapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • H pylori infection failed after at least two eradication therapies
  • aged 20 years or greater
  • willingness to receive rescue therapy

Exclusion Criteria:

  • aged less than 20 years
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555526


Contacts
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Contact: Jyh-Ming Liou, MD, PhD 886972651883 jyhmingliou@gmail.com
Contact: Mei-Jyh Chen, MD 886223123456 ext 63541 migichen@ntuh.gov.tw

Locations
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Taiwan
Jyh-Ming Liou Recruiting
Taipei, Taiwan, Taiwan-, Taiwan, 10002
Contact: Jyh-Ming Liou       jyhmingliou@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Jyh-Ming Liou, MD, PhD National Taiwan University Hospital (recruiting)
Principal Investigator: Yen-Nien Chen, MD National Taiwan University Hospital Hsin-Chu Branch
Principal Investigator: Yu Jen Fang, MD National Taiwan University Hospital, Yun-Lin Branch

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03555526    
Other Study ID Numbers: 201706037MINC
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tetracycline
Infection
Amoxicillin
Metronidazole
Clarithromycin
Levofloxacin
Ofloxacin
Esomeprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Antacids