NCT05023577

Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients

Clarithromycin-, Metronidazole-, or Levofloxacin-containing Therapy for Helicobacter Pylori-infected Penicillin-allergic Patients: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 504 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled clinical trial will compare the eradication efficacy of bismuth quadruple therapy containing clarithromycin+metronidazole, clarithromycin+levofloxacin, or metronidazole+levofloxacin for Helicobacter pylori first-line treatment in penicillin-allergic patients. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Rabeprazole	20mg bid
DRUG	Bismuth potassium citrate	0.6g bid
DRUG	Metronidazole	0.4g qid
DRUG	Clarithromycin	0.5g bid
DRUG	Levofloxacin	0.5g qd

Timeline

• Start date: 2021-08-26
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2021-08-26
• Last updated: 2021-09-14

Locations

1 site across 1 country: China