Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin

Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Levofloxacin; Drug: tinidazole

Detailed Description

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
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiuli Zuo, PhD,MD; Phone Number: 053188369277 15588818685; Email: zuoxiuli@sina.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Qilu hospital
      • Sub-Investigator: Minjuan Lin
      • Contact: Xiuli Zuo, PhD,MD; Phone Number: 053188369277 15588818685; Email: zuoxiuli@sina.com
      • Principal Investigator: Xiuli Zuo, PhD,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: levofloxacin-tetracycline-containing quadruple group; patients in levofloxacin-tetracycline-containing quadruple group will receive lansoprazole 30mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and levofloxacin 500mg po qd for 14d	Drug: Levofloxacin; levofloxacinn-tetracycline-containing quadruple regimens
Active Comparator: tinidazole-tetracycline-containing quadruple group; patients in tinidazole-tetracycline-containing quadruple group will receive lansoprazole 30mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and tinidazole 500mg po tid for 14d.	Drug: tinidazole; tinidazole-tetracycline-containing quadruple regimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months
The rate of adverse events happening	Similarly, adverse events will also be measured by the Likert scale.	24 months
The rate of good compliance	Patients taken over 90% of drugs are considered to have a good compliance.	24 months

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Xiuli Zuo, PhD,MD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Eradication; Allergic; Penicillin; Tetracycline
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Levofloxacin; Ofloxacin; Tinidazole
• Other Study ID Numbers: 2019-SDU-QILU-G709

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No