Clinical trial NCT03658746: Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection
Official title: Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection-A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Antimicrobial Susceptibility Testing
Rescue Therapy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day empirical therapy according to personal medication history.

Detailed description: Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been classified as the first risk factor of gastric cancer. Strong evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathological processes. Antimicrobial susceptibility test can pick out sensitive drugs to kill H.pylori, and reduce secondary drug resistance. However, there is a lack of high quality RCT to evaluate its efficacy in the rescue treatment of Helicobacter infection.

The investigator's study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Then, comparing this regimen with 14-day empirical therapy according to personal medication history to tell which one is better in clinic practice.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-70 with persistent Helicobacter pylori infection.
* Patients with previous Helicobacter pylori eradication therapy for one or two times.

Exclusion Criteria:

* Patients unable or unwilling to receive gastroscopy.
* Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Primary outcomes:
measure: Eradication rates
timeFrame: 6 months
Secondary outcomes:
measure: The rates of adverse events happening
timeFrame: 6 months
measure: The rates of improving dyspepsia symptoms after helicobacter pylori eradication.
timeFrame: 6 months
measure: The rates of good compliance.
timeFrame: 6 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: