Tailored Therapy for Helicobacter Pylori Rescue Treatment

• Sponsor: Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03413020
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 29.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: esomeprazole; Drug: bismuth Potassium Citrate; Drug: amoxicillin; Drug: clarithromycin; Drug: metronidazole; Drug: levofloxacin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Tailored for Helicobacter Pylori Rescue Treatment Based on Antimicrobial-susceptibility Testing
• Actual Study Start Date: Jan 3, 2018
• Actual Primary Completion Date: Jul 31, 2018
• Actual Study Completion Date: Jul 31, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Tailored Therapy 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; proton pump inhibitor; Drug: bismuth Potassium Citrate; gastric mucosal protective drug with anti-H. pylori effect; Drug: amoxicillin; antibiotic for H. pylori eradication; Drug: clarithromycin; antibiotic for H. pylori eradication; Drug: metronidazole; antibiotic for H. pylori eradication; Drug: levofloxacin; antibiotic for H. pylori eradication

Outcome Measures

Primary Outcome Measures

1. Helicobacter pylori eradication rate [Six weeks after completion of therapy]

   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).

Secondary Outcome Measures

1. Rate of adverse effects [Within 7 days after completion of therapy]

   The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).

2. Compliance rate [Within 7 days after completion of therapy]

   Compliance was defined as poor when they had taken less than 80% of the total medication.

Other Outcome Measures

1. Medical cost per patient of tailored therapy [Two months after completion of therapy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

• Shanghai Jiao Tong University School of Medicine

Investigators

• Principal Investigator: Hong Lu, M.D., Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT03413020
• Other Study ID Numbers: rjkls2017198
• First Posted: Jan 29, 2018
• Last Update Posted: Aug 7, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, Shanghai Jiao Tong University School of Medicine: Helicobacter pylori; Rescue therapy; Tailored therapy; Antimicrobial susceptibility testing
• Additional relevant MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Levofloxacin; Ofloxacin; Potassium Citrate; Esomeprazole; Bismuth

Study Results

No Results Posted as of Aug 7, 2018