Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin

NCT04122287 | Unknown Phase 4 DMC

• 1 other identifier: 2019-SDU-QILU-G709
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Pylori Infection

Keywords

Allergic; Penicillin; Helicobacter pylori; Eradication; Tetracycline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The rate of improving dyspepsia symptoms after Helicobacter pylori eradication

  24 months

• The rate of adverse events happening

  24 months

• The rate of good compliance

  24 months

Study Arms (2)

levofloxacin-tetracycline-containing quadruple group

EXPERIMENTAL

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

tinidazole-tetracycline-containing quadruple group

ACTIVE COMPARATOR

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

Interventions

Levofloxacin DRUG

levofloxacinn-tetracycline-containing quadruple regimens

levofloxacin-tetracycline-containing quadruple group

tinidazole DRUG

tinidazole-tetracycline-containing quadruple regimens

tinidazole-tetracycline-containing quadruple group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-70 with H. pylori infection.
• Patients Allergic to Penicillin.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hospital

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Interventions

Levofloxacin; Tinidazole

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Xiuli Zuo, PhD,MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, PhD,MD

CONTACT

15588818685; zuoxiuli@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: November 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

CN (1)