Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy

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Seoul National University

Status and phase

Completed
Phase 4

Conditions

Helicobacter Infections

Treatments

Drug: tetracycline
Drug: tripotassium dicitrate bismuthate
Drug: esomeprazole
Drug: amoxicillin
Drug: metronidazole
Drug: moxifloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT01792700
B-0603/031-013

Details and patient eligibility

About

patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and culture). In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.

Enrollment

648 patients

Sex

All

Ages

23 to 84 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients were considered persistent H. pylori infection if 13C-urea breath test (UBT) or invasive H. pylori test (Giemsa histology, CLO test, culture) were positive despite PPI-based triple therapy.

Exclusion criteria

  • Patients were excluded from the study if they had a history of renal or hepatic impairment, previous gastric surgery, pregnancy or lactation, therapy with steroids or non-steroidal anti-inflammatory drugs, or therapy with a proton pump inhibitor (PPI) or antibiotics within four weeks of entry.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

648 participants in 2 patient groups

MEA
Active Comparator group
Description:
MEA: moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.)
Treatment:
Drug: moxifloxacin
Drug: amoxicillin
Drug: esomeprazole
EBMT
Active Comparator group
Description:
EBMT: esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d)
Treatment:
Drug: metronidazole
Drug: esomeprazole
Drug: tripotassium dicitrate bismuthate
Drug: tetracycline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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