Empirical Rescue Therapies of Helicobacter Pylori Infection

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Functional Dyspepsia; Scarred Peptic Ulcer

Treatments: Drug: Bismuth; Drug: Metronidazole; Drug: Furazolidone; Drug: Tetracycline; Drug: Proton Pump Inhibitor; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT01668927

rjkls_2012009

Details and patient eligibility

About

The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. It is necessary to assess the efficacy and safety of these four bismuth-containing quadruple regimens with above antibiotics as empirical rescue therapies for H. pylori eradication.

Enrollment: 424 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• H. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who had previously failed one or more eradication regimens containing clarithromycin, metronidazole and/or amoxicillin.

Exclusion criteria

• less than 18 years old, never receiving eradication treatment before, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

424 participants in 4 patient groups

tetracycline/furazolidone

Experimental group

Description:

one of the four empirical rescue therapies

Treatment:

Drug: Furazolidone

Drug: Proton Pump Inhibitor

Drug: Tetracycline

Drug: Bismuth

amoxicillin/tetracycline

Experimental group

Description:

one of the four empirical rescue therapies

Treatment:

Drug: Proton Pump Inhibitor

Drug: Tetracycline

Drug: Amoxicillin

Drug: Bismuth

amoxicillin/furazolidone

Experimental group

Description:

one of the four empirical rescue therapies

Treatment:

Drug: Furazolidone

Drug: Proton Pump Inhibitor

Drug: Amoxicillin

Drug: Bismuth

tetracycline /metronidazole

Active Comparator group

Description:

Classical rescue therapy

Treatment:

Drug: Metronidazole

Drug: Proton Pump Inhibitor

Drug: Tetracycline

Drug: Bismuth