Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

NCT02935010 | Completed Phase 4 DMC

• 1 other identifier: rjkls2016110
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 5

Brief Summary

With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Bismuth quadruple therapy; Tailored therapy; Empiric therapy; clarithromycin susceptibility

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

Other Outcomes (3)

• Medical cost per patient of tailored or empiric therapy

  two months after completion of therapy

• Ratio of medical cost to H. pylori eradication rate of each therapy

  two months after completion of therapy

• Ratio of incremental medical cost to incremental H. pylori eradication rate of tailored compared with empiric therapy

  two months after completion of therapy

Study Arms (2)

Tailored therapy

EXPERIMENTAL

After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.

Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Metronidazole; Drug: Levofloxacin

Empiric therapy

ACTIVE COMPARATOR

give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days

Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Amoxicillin; Drug: Metronidazole

Interventions

Esomeprazole DRUG

proton pump inhibitor

Empiric therapy; Tailored therapy

Bismuth Potassium Citrate DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Empiric therapy; Tailored therapy

Amoxicillin DRUG

antibiotic for H. pylori eradication

Empiric therapy; Tailored therapy

Clarithromycin DRUG

antibiotic for H. pylori eradication

Tailored therapy

Metronidazole DRUG

antibiotic for H. pylori eradication

Empiric therapy; Tailored therapy

Levofloxacin DRUG

antibiotic for H. pylori eradication

Tailored therapy

Eligibility Criteria

• Age: 18 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 scarred peptic ulcer disease
• Ability and willingness to participate in the study and to sign and give informed consent
• confirmed H. pylori infection

You may not qualify if:

• Previous H. pylori eradication therapy
• Less than 18 years old
• With history of H. pylori infection treatment
• 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 (5)

Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200001, China

Location

Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200001, China

Location

Shanghai Tenth People's Hospital, Tongji University

Shanghai, Shanghai Municipality, 200001, China

Location

Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, 200001, China

Location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Interventions

Esomeprazole; Amoxicillin; Clarithromycin; Metronidazole; Levofloxacin

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; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Hong Lu, M.D.

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

• Yunwei Sun, M.D.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Hong Gao, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

• Yan Zhao, M.D.

  Shanghai Tenth People's Hospital, Tongji University

  PRINCIPAL INVESTIGATOR

• Gang Xu, M.D.

  Shanghai General Hospital, Shanghai First People's Hospital, 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: Doctor

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 17, 2016
• Study Start: February 5, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)