Tailored Therapy for Helicobacter Pylori Rescue Treatment

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy of Tailored for Helicobacter Pylori Rescue Treatment Based on Antimicrobial-susceptibility Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413020
• Other study ID #: rjkls2017198
• Status: Completed
• Phase: Phase 4
• Start date: January 3, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2018
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

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

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medical cost per patient of tailored therapy		Two months after completion of therapy
Primary	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	Rate of adverse effects	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).	Within 7 days after completion of therapy
Secondary	Compliance rate	Compliance was defined as poor when they had taken less than 80% of the total medication.	Within 7 days after completion of therapy