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NCT Number: NCT03658746

Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection

The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day empirical therapy according to personal medication history.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Qilu hosipital

Jinan, Shandong, 257000, China

About this study

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been classified as the first risk factor of gastric cancer. Strong evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathological processes. Antimicrobial susceptibility test can pick out sensitive drugs to kill H.pylori, and reduce secondary drug resistance. However, there is a lack of high quality RCT to evaluate its efficacy in the rescue treatment of Helicobacter infection.

The investigator's study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection. Then, comparing this regimen with 14-day empirical therapy according to personal medication history to tell which one is better in clinic practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-70 with persistent Helicobacter pylori infection.
  • Patients with previous Helicobacter pylori eradication therapy for one or two times.

Exclusion criteria

  • Patients unable or unwilling to receive gastroscopy.
  • Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
  • Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
  • Patients with known or suspected allergy to study medications.
  • Currently pregnant or lactating.
  • Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Treatment and study plan

two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)

Drug

Patients will receive a 14-day quadruple therapy for the H.pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.

one proton pump inhibitor, colloidal bismuth pectin

Drug

All patients need these two drugs.

two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)

Drug

Patients will receive a 14-day quadruple therapy according to personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient hasn't been treated with levofloxacin previously, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone.

Primary outcomes

  1. Eradication rates

    Time frame: 6 months

    Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

Secondary outcomes

  1. The rates of adverse events happening

    Time frame: 6 months

    Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.

  2. The rates of improving dyspepsia symptoms after helicobacter pylori eradication.

    Time frame: 6 months

    Dyspepsia symptoms will also be measured using a 8-point Likert scale.be compared. Common adverse events will be measured using a 8-point Likert scale. Patients rate their symptoms from 0 (none) to 8 (severe) before and after the treatment process.

  3. The rates of good compliance.

    Time frame: 6 months

    Patients taken over 90% of drugs are considered to have a good compliance.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection-A Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 5, 2018
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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