Empirical Rescue Therapies of Helicobacter Pylori Infection

NCT01668927 | Completed Phase 4

• 1 other identifier: rjkls_2012009
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia; Scarred Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

• eradication rate of H. pylori

  2 months

Study Arms (4)

tetracycline/furazolidone

EXPERIMENTAL

one of the four empirical rescue therapies

Drug: Proton Pump Inhibitor; Drug: Bismuth; Drug: Tetracycline; Drug: Furazolidone

amoxicillin/tetracycline

EXPERIMENTAL

one of the four empirical rescue therapies

Drug: Proton Pump Inhibitor; Drug: Bismuth; Drug: Tetracycline; Drug: Amoxicillin

amoxicillin/furazolidone

EXPERIMENTAL

one of the four empirical rescue therapies

Drug: Proton Pump Inhibitor; Drug: Bismuth; Drug: Furazolidone; Drug: Amoxicillin

tetracycline /metronidazole

ACTIVE COMPARATOR

Classical rescue therapy

Drug: Proton Pump Inhibitor; Drug: Bismuth; Drug: Metronidazole; Drug: Tetracycline

Interventions

Proton Pump Inhibitor DRUG

Also known as: Lansoprazole

amoxicillin/furazolidone; amoxicillin/tetracycline; tetracycline /metronidazole; tetracycline/furazolidone

Bismuth DRUG

Also known as: Bismuth potassium citrate

amoxicillin/furazolidone; amoxicillin/tetracycline; tetracycline /metronidazole; tetracycline/furazolidone

Metronidazole DRUG

tetracycline /metronidazole

Tetracycline DRUG

amoxicillin/tetracycline; tetracycline /metronidazole; tetracycline/furazolidone

Furazolidone DRUG

amoxicillin/furazolidone; tetracycline/furazolidone

Amoxicillin DRUG

amoxicillin/furazolidone; amoxicillin/tetracycline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

• Liang X, Xu X, Zheng Q, Zhang W, Sun Q, Liu W, Xiao S, Lu H. Efficacy of bismuth-containing quadruple therapies for clarithromycin-, metronidazole-, and fluoroquinolone-resistant Helicobacter pylori infections in a prospective study. Clin Gastroenterol Hepatol. 2013 Jul;11(7):802-7.e1. doi: 10.1016/j.cgh.2013.01.008. Epub 2013 Jan 29.

  PMID: 23376004 DERIVED

MeSH Terms

Interventions

Proton Pump Inhibitors; Lansoprazole; Bismuth; Metronidazole; Tetracycline; Furazolidone; Amoxicillin

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitrofurans; Oxazolidinones; Oxazoles; Furans; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of GI Division, Renji Hospital

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 20, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

CN (1)