Tailored Therapy for Helicobacter Pylori Rescue Treatment

NCT03413020 | Completed Phase 4 DMC

• 1 other identifier: rjkls2017198
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

With increasing antibiotic resistance and unsatisfactory results of empiric eradication regimens, tailored therapy may be the best choice to achieve high efficacy for rescue treatment. This study aimed to evaluate the eradication rates, safety, and compliance of antimicrobial susceptibility-based tailored therapy for rescue treatment in patients with Helicobacter pylori infection.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Rescue therapy; Tailored therapy; Antimicrobial susceptibility testing

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 (1)

• Medical cost per patient of tailored therapy

  Two months after completion of therapy

Study Arms (1)

Tailored Therapy

EXPERIMENTAL

After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole, amoxicillin and one sensitive of clarithromycin, metronidazole and levofloxacin.If isolates were resistant to all three tested antibiotics, give esomeprazole, bismuth potassium citrate, metronidazole and amoxicillin for 14 days.

Drug: esomeprazole; Drug: bismuth Potassium Citrate; Drug: amoxicillin; Drug: clarithromycin; Drug: metronidazole; Drug: levofloxacin

Interventions

esomeprazole DRUG

proton pump inhibitor

Tailored Therapy

bismuth Potassium Citrate DRUG

gastric mucosal protective drug with anti-H. pylori effect

Tailored Therapy

amoxicillin DRUG

antibiotic for H. pylori eradication

Tailored Therapy

clarithromycin DRUG

antibiotic for H. pylori eradication

Tailored Therapy

metronidazole DRUG

antibiotic for H. pylori eradication

Tailored Therapy

levofloxacin DRUG

antibiotic for H. pylori eradication

Tailored Therapy

Eligibility Criteria

• Age: 18 Years - 75 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
• Previous failures of H. pylori eradication therapy and need rescue therapy
• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection

You may not qualify if:

• Less than 18 years old
• 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)

• Yu L, Luo L, Long X, Liang X, Ji Y, Chen Q, Song Y, Li X, Graham DY, Lu H. Susceptibility-guided therapy for Helicobacter pylori infection treatment failures. Therap Adv Gastroenterol. 2019 Sep 9;12:1756284819874922. doi: 10.1177/1756284819874922. eCollection 2019.

  PMID: 31523279 DERIVED

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: January 22, 2018
• First Posted: January 29, 2018
• Study Start: January 3, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)