Empirical Rescue Therapies of Helicobacter Pylori Infection

Phase 4

Completed

• Conditions: Functional Dyspepsia; Scarred Peptic Ulcer
• Interventions: Drug: Proton Pump Inhibitor; Drug: Bismuth; Drug: Furazolidone; Drug: Tetracycline; Drug: Metronidazole; Drug: Amoxicillin

• Registration Number: NCT01668927
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-20
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-01
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tetracycline/furazolidone	Proton Pump Inhibitor	one of the four empirical rescue therapies
tetracycline/furazolidone	Bismuth	one of the four empirical rescue therapies
amoxicillin/tetracycline	Proton Pump Inhibitor	one of the four empirical rescue therapies
amoxicillin/tetracycline	Bismuth	one of the four empirical rescue therapies
amoxicillin/furazolidone	Proton Pump Inhibitor	one of the four empirical rescue therapies
amoxicillin/furazolidone	Bismuth	one of the four empirical rescue therapies
amoxicillin/furazolidone	Furazolidone	one of the four empirical rescue therapies
amoxicillin/furazolidone	Amoxicillin	one of the four empirical rescue therapies
tetracycline /metronidazole	Proton Pump Inhibitor	Classical rescue therapy
tetracycline /metronidazole	Bismuth	Classical rescue therapy
tetracycline/furazolidone	Tetracycline	one of the four empirical rescue therapies
amoxicillin/tetracycline	Tetracycline	one of the four empirical rescue therapies
tetracycline/furazolidone	Furazolidone	one of the four empirical rescue therapies
amoxicillin/tetracycline	Amoxicillin	one of the four empirical rescue therapies
tetracycline /metronidazole	Metronidazole	Classical rescue therapy
tetracycline /metronidazole	Tetracycline	Classical rescue therapy

Primary Outcome Measures

Name	Time	Method
eradication rate of H. pylori	2 months

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China