Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy of Two Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02988089
• Other study ID #: 2016SDU-QILU-23
• Status: Recruiting
• Phase: Phase 4
• First received: December 4, 2016
• Last updated: April 23, 2017
• Start date: April 20, 2017
• Est. completion date: September 2017

Study information

• Verified date: April 2017
• Source: Shandong University
• Contact: Li Yanqing, MD, PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.

Exclusion Criteria:

• Enable to undergo upper endoscopy;

• Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;

• Known or suspected allergy to study medications;

• Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;

• Currently pregnant or lactating

• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Related Conditions & MeSH terms

• Antimicrobial Susceptibility Testing
• Disease Susceptibility
• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• Clarithromycin susceptibility dependant strategy
Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. Antimicrobial susceptibility testing (AST) will be used to test the susceptibility of clarithromycin. If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen.
• 2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline )
Patients in this group will receive a a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, Colloidal Bismuth Pectin and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
• proton pump inhibitor (PPI) and Colloidal Bismuth Pectin
all patients need these two drugs.
• amoxicillin and clarithromycin or amoxicillin and furazolidone
patients in the 6 antibiotics dependant group will use these intervention.
• amoxicillin and furazolidone or amoxicillin and tetracycline
salvage therapy for negative culture when the results of culture are negative
• amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin
salvage therapy for failed eradication if failed with AST guided eradication therapy

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Ji'nan	Shandong

Sponsors (5)

Lead Sponsor	Collaborator
Shandong University	Binzhou People's Hospital, General Hospital of Jinan Military Region, Liaocheng People's Hospital, Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rates in 2 groups		6 months
Secondary	the rate of improving dyspepsia symptoms after H. pylori eradication		6 months
Secondary	the rate of adverse events happening		6 months
Secondary	the rate of good compliance (take pills more than 90%)		5 months
Secondary	difference of cost per patient for each eradication achieved in 2 groups		6 months