Tailored Therapy for Helicobacter Pylori Rescue Treatment

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03413020

rjkls2017198

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Less than 18 years old
• With previous gastric surgery
• Major systemic diseases
• Pregnancy or lactation
• Allergy to any of the study drugs
• Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Tailored Therapy

Experimental group

Description:

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.

Treatment:

Drug: clarithromycin

Drug: bismuth Potassium Citrate

Drug: metronidazole

Drug: amoxicillin

Drug: esomeprazole

Drug: levofloxacin