Helicobacter Pylori Rescue Treatment in Patients Allergic to Penicillin

NCT05135182 | Unknown Phase 4 DMC

• 1 other identifier: 2021-SDU-QILU-G226
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess and compare the effectiveness of furazolidone-tetracycline-containing and metronidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection inpatients 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.

  12 months

Study Arms (2)

furazolidone-tetracycline-containing quadruple

EXPERIMENTAL

patients in furazolidone-tetracycline-containing quadruple group will receive vonoprazan fumarate 20mg po bid, tetracycline 500mg po qid , bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone 100mg po bid for 14d

Drug: Furazolidone

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

Furazolidone DRUG

Furazolidone-tetracycline-containing quadruple regimens

furazolidone-tetracycline-containing quadruple

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 with previous Helicobacter pylori eradication.
• Patients Allergic to Penicillin.

You may not qualify if:

• Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
• Patients with gastrectomy, acute GI 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hosipital

Jinan, Shandong, 257000, China

RECRUITING

MeSH Terms

Interventions

Furazolidone; Metronidazole

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Furans; Nitroimidazoles; Imidazoles

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

Xiuli Zuo

CONTACT

15588818685; zuoxiuli@sina.com

Study Design

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

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: November 26, 2021
• Study Start: November 28, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

CN (1)