High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment

NCT04024527 | Completed Phase 4 DMC

• 1 other identifier: rjyy20190715
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value)

  Six weeks after completion of therapy

Secondary Outcomes (2)

• Rate of adverse effects

  Within 7 days after completion of therapy

• Compliance rate

  Within 7 days after completion of therapy

Study Arms (2)

Dual therapy

ACTIVE COMPARATOR

Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days

Drug: Esomeprazole; Drug: Amoxicillin

Metronidazole plus dual therapy

EXPERIMENTAL

Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Drug: Esomeprazole; Drug: Amoxicillin; Drug: Metronidazole

Interventions

Esomeprazole DRUG

Proton pump inhibitor

Dual therapy; Metronidazole plus dual therapy

Amoxicillin DRUG

Antibiotic for H. pylori eradication

Dual therapy; Metronidazole plus dual therapy

Metronidazole DRUG

Antibiotic for H. pylori eradication

Metronidazole plus dual therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with non-ulcer functional dyspepsia or peptic ulcer disease
• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection and with previous treatment failure

You may not qualify if:

• Less than 18 years old or older than 80 years
• With previous gastric surgery
• Major systemic diseases
• Pregnancy or lactation
• Allergy to any of the study drugs

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

• Ding ZH, Huang Y, Chen JN, Luo LS, Zhang W, Liang X, Lu H. A randomized superiority clinical trial: metronidazole improved the efficacy of high-dose dual therapy in Helicobacter pylori rescue treatment. J Antimicrob Chemother. 2023 Mar 2;78(3):828-831. doi: 10.1093/jac/dkad020.

  PMID: 36719104 DERIVED

MeSH Terms

Interventions

Esomeprazole; Amoxicillin; Metronidazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Hong Lu, M.D.,Ph.D.

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 18, 2019
• Study Start: July 25, 2019
• Primary Completion: April 12, 2021
• Study Completion: May 24, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)