Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy of Antibiotic Susceptibility-based Tailored Versus Empiric Therapy for Helicobacter Pylori First-line Treatment：a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935010
• Other study ID #: rjkls2016110
• Status: Completed
• Phase: Phase 4
• Start date: February 5, 2017
• Est. completion date: March 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 markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants with 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:

• Previous H. pylori eradication therapy

• Less than 18 years old

• With history of H. pylori infection treatment

• 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
China	Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai
China	Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University	Shanghai	Shanghai
China	Shanghai Tenth People's Hospital, Tongji University	Shanghai	Shanghai
China	Zhongshan Hospital,Fudan 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 or empiric therapy		two months after completion of therapy
Other	Ratio of medical cost to H. pylori eradication rate of each therapy		two months after completion of therapy
Other	Ratio of incremental medical cost to incremental H. pylori eradication rate of tailored compared with empiric 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	During the 14-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. 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). The side effect score recorded was based on the most severe event.	within 7 days after completion of therapy
Secondary	Compliance rate	Compliance was de?ned as poor when they had taken less than 80% of the total medication.	within 7 days after completion of therapy