Clarithromycin Susceptibility-Guided Treatment of Helicobacter Pylori Infection

Sponsor

Liaocheng People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05549115

Collaborator

(none)

500

Enrollment

Location

Arms

Anticipated Duration (Months)

33.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to assess the safety and efficacy of clarithromycin susceptibility-guided therapy as the first line treatment for H pylori infection compared with empirical bismuth-containing quadruple therapy.

Condition or Disease	Intervention/Treatment	Phase
H.Pylori Infection	Drug: clarithromycin-containing triple therapy Drug: bismuth quadruple therapy Drug: a PPI-amoxicillin high-dose dual therapy Drug: a fluoroquinolone-containing quadruple therapy	N/A

Detailed Description

Clarithromycin is the second popular drug to eradicate H. pylori infection(79.0%) used by physicians in China. however, clarithromycin resistance is greater than 15% in most China regions. Clarithromycin susceptibility testing is recommended before prescribing any clarithromycin containing therapy by Maastricht VI/Florence consensus report. However, whether patients should systematically undergo an upper endoscopy for bacterial culture (or molecular techniques such as PCR) before administering H. pylori eradication treatment in clinical practice remains a contentious debate. So we designed this study to assess the safety and efficacy of clarithromycin susceptibility-guided therapy as the first line treatment for H pylori infection compared with empirical bismuth-containing quadruple therapy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clarithromycin Susceptibility-Guided Therapy as the First-Line Treatment for Helicobacter Pylori Infection: a Randomized Controlled Trial.

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: susceptibility-guided group clarithromycin-containing triple therapy	Drug: clarithromycin-containing triple therapy esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, bid,14d Other Names: no clarithromycin resistance
Experimental: control group bismuth quadruple therapy	Drug: bismuth quadruple therapy esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, bid, plus bismuth 150mg,qid 14d Other Names: control
Experimental: susceptibility-guided group positive C13-UBT positive after treatment	Drug: a fluoroquinolone-containing quadruple therapy esomeprazole 20 mg, amoxicillin 1 g, bid, levofloxacin 50mg, qd, plus bismuth 150mg,qid 14d
Experimental: control group positive C13-UBT positive after treatment	Drug: a PPI-amoxicillin high-dose dual therapy esomeprazole 20 mg, amoxicillin 750mg, qid, 14d Other Names: clarithromycin resistance
Experimental: susceptibility-guided group resistance clarithromycin resistance	Drug: a PPI-amoxicillin high-dose dual therapy esomeprazole 20 mg, amoxicillin 750mg, qid, 14d Other Names: clarithromycin resistance

Outcome Measures

Primary Outcome Measures

the 1st H. pylori cure rate [one month after the treatment]
first-line the cure rate of the first line H. pylori eradication treatments

Secondary Outcome Measures

the 2nd H. pylori cure rate [one month after the second treatment]
second-line
the high-dose dual therapy cure rate [one month after the second treatment]
high-dose PPI-amoxicillin dual therapy
Adverse reaction [one week after the first and second treatment]