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Comparing the Efficacy of 10-day Reverse Hybrid Therapy and 10-day Triple Therapy Plus Bismuth Therapy.

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ClinicalTrials.gov Identifier: NCT04566211
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Feng-Woei Tsay, Kaohsiung Veterans General Hospital.

Study Description
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Brief Summary:
Reverse hybrid therapy achieves a higher eradication rate than triple therapy plus bismuth therapy remains unanswered.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: (panto+amox+clar+metr)+(panto+amox) Drug: pantoprazole+bismuth+amox+clar Not Applicable

Detailed Description:
With the rising prevalence of antimicrobial resistance, the failure rate of the 7-day standard triple therapy has declined to unacceptable level (<80%) worldwide. Several regimens were suggested to replace standard triple therapy in the area with high clarithromycin resistance, including sequential therapy, concomitant therapy, hybrid therapy and bismuth containing quadruple therapy. A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving eradication rates of 95%. A clinical trial by Hsu et al from our hospital showed 12-day reverse hybrid therapy also achieved high eradication rate, and improved the compliance of patients. Even prolong the treatment duration of standard triple therapy from 7 days to 12 days, the efficacy of eradication was still < 90% (85-88%). The limitation of triple therapy in against resistant-stains was still existed. The addition of bismuth (triple therapy plus bismuth) can improve cure rates despite a high prevalence of antimicrobial resistance. The major bismuth effect is to add an additional 30%-40% to the success with resistant infections. However the direct compare the efficacy between 10-day reverse hybrid therapy and 10-day triple therapy plus bismuth is still insufficiency in Taiwan and worldwide. Choosing a navel therapy or a modifying triple therapy can get better efficacy, it is remained to be determined. Besides genotyping polymorphism of CYP2C19 influenced the metabolism of proton pump inhibit, and could cause decreasing of eradication rate of standard triple therapy. But the influence in 10-day reverse hybrid therapy and 10-day triple therapy plus bismuth is unclear.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparing 10-day Reverse Hybrid Therapy and 10-day Triple Therapy Plus Bismuth Therapy on Helicobacter Pylori Eradication
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: (panto+amox+clar+metr)+(panto+amox)
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
 Drug: (panto+amox+clar+metr)+(panto+amox)
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
Other Names:
  • pantoprazole 40 mg
  • amoxicillin 1 g
  • clarithromycin 500 mg
  • metronidazole 500 mg
Active Comparator: pantoprazole+bismuth+amox+clar
pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days
 Drug: pantoprazole+bismuth+amox+clar
pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days
Other Names:
  • pantoprazole 40 mg
  • bismuth subcitrate 120 mg
  • amoxicillin 1 g
  • clarithromycin 500 mg


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants in Which H. Pylori Was Eradicated [ Time Frame: sixth week after the end of anti- H. pylori therapy ]
    To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

  • previous H pylori-eradication therapy
  • ingestion of antibiotics or bismuth within the prior 4 weeks
  • patients with allergic history to the medications used
  • patients with previous gastric surgery
  • the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
  • pregnant women
Contacts and Locations
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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): NCT04566211


Contacts
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Contact: Feng-Woei Tsay, Bachelor +886-7-342-2121 ext 72075 fwchaie@vghks.gov.tw

Locations
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Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 813
Contact: Feng-Woei Tsay, Bachelor    886-7346-8233    fwchaie@vghks.gov.tw   
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Principal Investigator: Feng-Woei Tsay, Bachelor Kaohsiung Veterans General Hospital.
More Information
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Responsible Party: Feng-Woei Tsay, Assistant Professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT04566211    
Other Study ID Numbers: VGHKS19-CT6-15
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Feng-Woei Tsay, Kaohsiung Veterans General Hospital.:
Helicobacter pylori
Eradication rate
Additional relevant MeSH terms:
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Amoxicillin
Metronidazole
Clarithromycin
Bismuth tripotassium dicitrate
Pantoprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
 Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Antacids