Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori

Shanghai Jiao Tong University School of Medicine

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: amoxicillin rifabutin; Drug: Esomeprazole; Drug: Tetracycline,Metronidazole; Drug: Bismuth Potassium Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04879992

rjcjn20210506

Details and patient eligibility

About

Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori

Enrollment: 413 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection and with previous treatment experience

Exclusion criteria

• Less than 18 years old
• With previous gastric surgery
• Previous history of tuberculosis
• Major systemic diseases
• Pregnancy or lactation
• Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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413 participants in 2 patient groups

Tetracycline Bismuth Quadruple Therapy

Active Comparator group

Description:

Esomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid

Treatment:

Drug: Esomeprazole

Drug: Tetracycline,Metronidazole

Drug: Bismuth Potassium Citrate

rifabutin triple therapy

Experimental group

Description:

Esomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid

Treatment:

Drug: Esomeprazole

Drug: amoxicillin rifabutin