High Dose Amoxicillin Versus Tetracycline as Second-line Treatment of Resistant Helicobacter Pylori Infection
Information source: Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Helicobacter Pylori Treatment Failure
Intervention: Lansoprazole (Drug); Bismuth Potassium Citrate (Drug); Metronidazole (Drug); Amoxicillin (Drug); Tetracycline (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Shanghai Jiao Tong University School of Medicine Official(s) and/or principal investigator(s): Hong Lu, M.D., Principal Investigator, Affiliation: Renji Hospital, Shanghai Jiao-Tong University School of Medicine
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Eradication rate of Helicobacter pylori
Secondary outcome: Frequency of side effects of each treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Shanghai Renji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, Shanghai 200127, China
Additional Information
Related publications: 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. 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. Review.
Starting date: July 2014
Last updated: May 23, 2015
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