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Trial record 15 of 150 for:    tetracycline

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

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ClinicalTrials.gov Identifier: NCT02175927
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Treatment Failure Drug: Lansoprazole Drug: Bismuth Potassium Citrate Drug: Metronidazole Drug: Amoxicillin Drug: Tetracycline Phase 4

Detailed Description:

Helicobacter pylori is the most successful human pathogen infecting an estimated 50% of the global population, and is associated with a spectrum of disease states, including chronic gastritis, duodenal and gastric ulcer, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue lymphoma (MALToma).

Most Consensus Conferences and Clinical Guidelines recommend the prescription of a triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole, as first-line treatment. However, the effectiveness of these triple-therapy regimens seems to have diminished over time, largely as a result of emerging resistance of the organism to clarithromycin. Avoiding problems due to antibiotic resistance has become an important issue when deciding a second-line rescue therapy for H. pylori infection

Bismuth-containing quadruple therapies have been used widely in second-line therapy of H. pylori infection, and are recommended by the Maastricht IV Consensus Conference report. Quadruple therapy can achieve a high rate of eradication success as a second-line treatment. A meta-analysis of quadruple therapy showed that metronidazole resistance had limited effect on the outcome when adequate dosages and durations are used. This meta-analysis also showed that compliance with quadruple therapy is high. Classical bismuth-based quadruple therapy consists of a PPI, bismuth, tetracycline and metronidazole. This regiment meets the proposed criteria for a second-line treatment: it does not contain the key antibiotic of the original regimen (clarithromycin), the treatment is not affected by clarithromycin resistance, metronidazole resistance in vitro does not affect the outcome of quadruple therapy significantly, compliance with the regimen is high and the regimen is effective in most parts of the world. But this regiment has high rate of side effects because of tetracycline.

Amoxicillin has low resistance rate as well as low percentage of side effects. The replacement of tetracycline by high dose amoxicillin in classical bismuth-containing quadruple therapy may be a better choice. Therefore, we will do a randomized trial to compare the eradication rate of 14-day high dose amoxicillin and metronidazole based bismuth-containing quadruple therapy with classical quadruple therapy for second-line Helicobacter pylori treatment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Controlled Trial Comparing High Dose Amoxicillin Versus Tetracycline Based Quadruple Therapy as Second-line Treatment for Resistant Helicobacter Pylori Infection
Study Start Date : July 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Dose Amoxicillin
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
antisecretory drug of each quadruple therapy
Other Name: proton pump inhibitor

Drug: Bismuth Potassium Citrate
one component of each quadruple therapy
Other Name: Bismuth

Drug: Metronidazole
antibiotic of each quadruple therapy
Other Name: antibiotic

Drug: Amoxicillin
antibiotic of high dose amoxicillin based quadruple therapy
Other Name: antibiotic

Active Comparator: Tetracycline
Classical quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid
Drug: Lansoprazole
antisecretory drug of each quadruple therapy
Other Name: proton pump inhibitor

Drug: Bismuth Potassium Citrate
one component of each quadruple therapy
Other Name: Bismuth

Drug: Metronidazole
antibiotic of each quadruple therapy
Other Name: antibiotic

Drug: Tetracycline
antibiotic of classical quadruple therapy
Other Name: antibiotic




Primary Outcome Measures :
  1. Eradication rate of Helicobacter pylori [ Time Frame: 2 months ]
    Access eradication rate of H. pylori by intention to treat (ITT) and per-protocol (PP) analysis in each treatment group


Secondary Outcome Measures :
  1. Frequency of side effects of each treatment [ Time Frame: 2 months ]
    Score side effects as mild, moderate or severe according to their influence on daily activities


Other Outcome Measures:
  1. Minimal inhibitory concentrations (MIC) of antibiotics against each helicobacter pylori clinical isolate [ Time Frame: 2 months ]
    Determine MIC of amoxicillin, tetracycline, and metronidazole by the twofold agar dilution method.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175927


Locations
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China, Shanghai
Shanghai Renji Hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Hong Lu, M.D. RenJi Hospital

Publications:
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Responsible Party: Hong Lu, MD, Professor of GI Division, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02175927     History of Changes
Other Study ID Numbers: rjkls2014007
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: December 2015
Keywords provided by Hong Lu, MD, Shanghai Jiao Tong University School of Medicine:
Helicobacter pylori
Treatment Failure
second-line therapy
Additional relevant MeSH terms:
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Tetracycline
Infection
Anti-Bacterial Agents
Amoxicillin
Metronidazole
Antibiotics, Antitubercular
Potassium Citrate
Lansoprazole
Dexlansoprazole
Bismuth
Citric Acid
Sodium Citrate
Proton Pump Inhibitors
Anti-Infective Agents
Antitubercular Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Antacids
Protein Synthesis Inhibitors
Diuretics
Natriuretic Agents
Physiological Effects of Drugs