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

Sponsor

Kaohsiung Veterans General Hospital. (Other)

Overall Status

Recruiting

CT.gov ID

NCT04566211

Collaborator

(none)

440

Enrollment

Location

Arms

Anticipated Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2020

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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)

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

Primary Outcome Measures

Number of Participants in Which H. Pylori Was Eradicated [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

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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