NCT02359331

The Efficacy of the 7 Days Tailored Therapy as 2nd Rescue Therapy for Eradication of H. Pylori Infection

A Prospective, Single-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare the 14-day Bismuth Quadruple Therapy and 7-day Culture Based Tailored Therapy for the Eradication of Helicobacter as a Rescue 2nd Therapy.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter pylori (H. pylori) therapies has been declined coincidentally. In this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 14 days bismuth contained quadruple 2nd rescue regimens, and the investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored therapy group.

Detailed description

The patients who had shown the evidence of persistent H. pylori infection after the 1st eradication were enrolled for this study. After giving the informed consent about the method and efficacy (ITT and PP analysis) of the 14 days bismuth quadruple 2nd rescue therapy and the 7 days tailored therapy for H. pylori infection based on culture and MIC, the patients were randomly classified into the two regimen group under the patient's agreement and underwent 2nd eradication \[14 days bismuth-based quadruple therapy (Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.), or 7 days tailored therapy based on H. pylori culture and MIC (select the 2nd rescue regimen between 7 days of bismuth-based quadruple therapy or 7 days moxifloxacin-containing triple therapy (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.) according to antibiotics susceptibility. This study was designed to evaluate the success of eradication for enrolled participants by methods of an open labelled randomized prospectively.

Conditions

• Helicobacter Infection

Interventions

Type	Name	Description
PROCEDURE	H. pylori culture and antimicrobial susceptibility testing	This intervention will be performed in 7 days tailored therapy group. All the patients who enrolled in this arm, they will be received endoscopy guided biopsy procedure. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin, clarithromycin, metronidazo, tetracycline and moxifloxacin for the H. pylori isolates were examined by use of the serial two fold agar dilution method
DRUG	14 days empirical bismuth quadruple therapy (Proton pump inhibitor)	Giving the 14 days PBMT regimen as 2nd rescue therapy Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.
DRUG	Metronidazole
DRUG	Tetracycline
DRUG	tripotassium dicitrate bismuthate
DRUG	7 days tailored therapy Proton Pump Inhibitor
DRUG	Moxifloxacin
DRUG	Amoxicillin

Timeline

• Start date: 2014-08-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2015-02-10
• Last updated: 2023-04-13

Locations

1 site across 1 country: South Korea