Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin

NCT05129176 | Unknown Phase 4 DMC

• 1 other identifier: 2021-SDU-QILU-G709
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Eradication; Allergic; Penicillin; 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.

  12 months

Secondary Outcomes (2)

• The rate of improving dyspepsia symptoms after Helicobacter pylori eradication

  12 months

• The rate of adverse events happening

  12 months

Study Arms (2)

levofloxacin-tetracycline-containing quadruple group

EXPERIMENTAL

patients in levofloxacin-tetracycline-containing quadruple group will receive vonoprazan fumarate 20mg po bid, tetracycline 500mg po qid , bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d

Drug: Levofloxacin

metronidazole-tetracycline-containing quadruple group

ACTIVE COMPARATOR

patients in metronidazole-tetracycline-containing quadruple group will receive vonoprazan fumarate 20mg po bid, tetracycline 500mg po qid , bismuth potassium citrate(Lizhudele) 220mg po bid, and metronidazole 400mg po qid for 14d

Drug: Metronidazole

Interventions

Levofloxacin DRUG

levofloxacin-tetracycline-containing quadruple regimens

levofloxacin-tetracycline-containing quadruple group

Metronidazole DRUG

Metronidazole-tetracycline-containing quadruple regimens

metronidazole-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; Metronidazole

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, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD,PhD

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: Professor, Director of gastroenterology department of Qiluhospital

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 22, 2021
• Study Start: November 23, 2021
• Primary Completion: July 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

CN (1)