Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin

Shandong University250 enrolled

Overview

The purpose of this study is to assess and compare the effectiveness of levofloxacin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin. Therefore, the investigators aim to assess and compare the effectiveness of levofloxacin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

250

Conditions

Helicobacter Pylori Infection

Interventions

LevofloxacinDRUG

levofloxacinn-tetracycline-containing quadruple regimens

tinidazoleDRUG

tinidazole-tetracycline-containing quadruple regimens

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18-70 with H. pylori infection. * Patients Allergic to Penicillin. Exclusion Criteria: * Patients with previous H. pylori eradication therapy. * 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

Locations (1)

Qilu hospital

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

Eradication rates in 2 groups

Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. 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.

Time frame: 24 months

Secondary Outcomes

The rate of improving dyspepsia symptoms after Helicobacter pylori eradication

Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication.

Time frame: 24 months

The rate of adverse events happening

Similarly, adverse events will also be measured by the Likert scale.

Time frame: 24 months

The rate of good compliance

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

Time frame: 24 months

Central Contacts

Xiuli Zuo, PhD,MD

CONTACT

15588818685 zuoxiuli@sina.com

Data from ClinicalTrials.gov

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