High Dose Amoxicillin Versus Tetracycline as Second-line Treatment of Resistant Helicobacter Pylori Infection

NCT02175927 | Completed Phase 4

• 1 other identifier: rjkls2014007
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

No trial has examined the the efficacy of high dose amoxicillin based quadruple therapy as second-line treatment for Helicobacter pylori infection. The study aims to compare the effectiveness and safety of 14-day high dose amoxicillin-based quadruple regiment with classical quadruple regiment for rescue eradication of Helicobacter pylori.

Conditions

Helicobacter Pylori Treatment Failure

Keywords

Helicobacter pylori; Treatment Failure; second-line therapy

Outcome Measures

Primary Outcomes (1)

• Eradication rate of Helicobacter pylori

  Access eradication rate of H. pylori by intention to treat (ITT) and per-protocol (PP) analysis in each treatment group

  2 months

Secondary Outcomes (1)

• Frequency of side effects of each treatment

  2 months

Other Outcomes (1)

• Minimal inhibitory concentrations (MIC) of antibiotics against each helicobacter pylori clinical isolate

  2 months

Study Arms (2)

High Dose Amoxicillin

EXPERIMENTAL

High dose amoxicillin/metronidazole-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg tid, Metronidazole 400mg qid

Drug: Lansoprazole; Drug: Bismuth Potassium Citrate; Drug: Metronidazole; Drug: Amoxicillin

Tetracycline

ACTIVE COMPARATOR

Classical quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid

Drug: Lansoprazole; Drug: Bismuth Potassium Citrate; Drug: Metronidazole; Drug: Tetracycline

Interventions

Lansoprazole DRUG

antisecretory drug of each quadruple therapy

Also known as: proton pump inhibitor

High Dose Amoxicillin; Tetracycline

Bismuth Potassium Citrate DRUG

one component of each quadruple therapy

Also known as: Bismuth

High Dose Amoxicillin; Tetracycline

Metronidazole DRUG

antibiotic of each quadruple therapy

Also known as: antibiotic

High Dose Amoxicillin; Tetracycline

Amoxicillin DRUG

antibiotic of high dose amoxicillin based quadruple therapy

Also known as: antibiotic

High Dose Amoxicillin

Tetracycline DRUG

antibiotic of classical quadruple therapy

Also known as: antibiotic

Tetracycline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before
• indication of rescue H pylori eradication treatment
• Ability and willingness to participate in the study and to sign and give informed consent

You may not qualify if:

• patients less than 18 years old
• previous gastric surgery
• pregnancy or lactation
• major systemic diseases,
• administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks
• allergy to any one of the medication used in the quadruple regimens.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Renji Hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (2)

• Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.

  PMID: 22491499 BACKGROUND

• Lu H, Zhang W, Graham DY. Bismuth-containing quadruple therapy for Helicobacter pylori: lessons from China. Eur J Gastroenterol Hepatol. 2013 Oct;25(10):1134-40. doi: 10.1097/MEG.0b013e3283633b57.

  PMID: 23778309 BACKGROUND

MeSH Terms

Interventions

Lansoprazole; Proton Pump Inhibitors; Bismuth; Metronidazole; Anti-Bacterial Agents; Amoxicillin; Tetracycline

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hong Lu, M.D.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 1, 2016

Record last verified: 2015-12

Locations

CN (1)