Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy

Helicobacter Pylori Infection Clinical Trial

Official title:

Antibiotic Susceptibility-based Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy: a Prospective Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708848
• Other study ID #: rjkls2017197
• Status: Completed
• Phase: Phase 4
• Start date: December 5, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2019
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Increasing drug resistance presents a significant challenge to the efficacies of common empiric eradication regimens for Helicobacter pylori treatment in the mainland of China. Tailored therapy may be the best choice to achieve good efficacy, especially in patients with penicillin allergy. Few studies had evaluated the patients with penicillin allergy.This study is designed to evaluate the efficacy and safety of antibiotic sensitivity-based tailored therapy for Helicobacter pylori treatment in the patients with penicillin allergy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants with penicillin allergy who have 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

Exclusion Criteria:

• Patients without penicillin allergy

• 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 Pylori Infection
• Hypersensitivity

Intervention

Drug:
• Esomeprazole
Proton pump inhibitor
• Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
• Clarithromycin
antibiotic for H. pylori eradication
• Metronidazole
antibiotic for H. pylori eradication
• Levofloxacin
antibiotic for H. pylori eradication
• Tetracycline
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
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