Clarithromycin Susceptibility-Guided Treatment of Helicobacter Pylori Infection

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

Sponsors

Lead Sponsor: Liaocheng People's Hospital

Source Liaocheng People's Hospital
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.

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.

Overall Status Recruiting
Start Date 2022-09-20
Completion Date 2023-12-01
Primary Completion Date 2023-10-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
the 1st H. pylori cure rate one month after the treatment
Secondary Outcome
Measure Time Frame
the 2nd H. pylori cure rate one month after the second treatment
the high-dose dual therapy cure rate one month after the second treatment
Adverse reaction one week after the first and second treatment
Enrollment 500
Condition
Intervention

Intervention Type: Drug

Intervention Name: clarithromycin-containing triple therapy

Description: esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, bid,14d

Arm Group Label: susceptibility-guided group

Other Name: no clarithromycin resistance

Intervention Type: Drug

Intervention Name: bismuth quadruple therapy

Description: esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, bid, plus bismuth 150mg,qid 14d

Arm Group Label: control group

Other Name: control

Intervention Type: Drug

Intervention Name: a PPI-amoxicillin high-dose dual therapy

Description: esomeprazole 20 mg, amoxicillin 750mg, qid, 14d

Other Name: clarithromycin resistance

Intervention Type: Drug

Intervention Name: a fluoroquinolone-containing quadruple therapy

Description: esomeprazole 20 mg, amoxicillin 1 g, bid, levofloxacin 50mg, qd, plus bismuth 150mg,qid 14d

Arm Group Label: susceptibility-guided group positive

Eligibility

Criteria:

Inclusion Criteria: - patients for first-line treatment of Helicobacter pylori infection Exclusion Criteria: - penicillin allergy - pregnancy and lactation

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jing run Zhao, Dr Study Chair Liaocheng People's Hospital
Overall Contact

Last Name: Jing run Zhao, Dr

Phone: +86-635-8276373

Email: [email protected]

Location
Facility: Status: Contact: Liaocheng people's hospital Jingrun Zhao, Dr +86-635-8276373 [email protected]
Location Countries

China

Verification Date

2022-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: susceptibility-guided group

Type: Experimental

Description: clarithromycin-containing triple therapy

Label: control group

Type: Experimental

Description: bismuth quadruple therapy

Label: susceptibility-guided group positive

Type: Experimental

Description: C13-UBT positive after treatment

Label: control group positive

Type: Experimental

Description: C13-UBT positive after treatment

Label: susceptibility-guided group resistance

Type: Experimental

Description: clarithromycin resistance

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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