Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin

Sponsor

Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04264663

Collaborator

(none)

250

Enrollment

Location

Arms

37.9

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Furazolidone Drug: Tinidazole	Phase 4

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 furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: furazolidone-tetracycline-containing quadruple patients in furazolidone-tetracycline-containing quadruple group will receive Esomeprazole 40mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and furazolidone 100mg po bid for 14d	Drug: Furazolidone Furazolidone-tetracycline-containing quadruple regimens
Active Comparator: tinidazole-tetracycline-containing quadruple group patients in tinidazole-tetracycline-containing quadruple group will receive Esomeprazole 40mg 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

Arm

Intervention/Treatment

Experimental: furazolidone-tetracycline-containing quadruple

patients in furazolidone-tetracycline-containing quadruple group will receive Esomeprazole 40mg po bid, tetracycline 500mg po qid , bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and furazolidone 100mg po bid for 14d

Drug: Furazolidone

Furazolidone-tetracycline-containing quadruple regimens

Active Comparator: tinidazole-tetracycline-containing quadruple group

patients in tinidazole-tetracycline-containing quadruple group will receive Esomeprazole 40mg 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

Outcome Measures

Primary Outcome Measures

Eradication rates in 2 groups [12months]
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.

Secondary Outcome Measures

The rate of improving dyspepsia symptoms after Helicobacter pylori eradication [12months]
The rate of improving dyspepsia symptoms after Helicobacter pylori eradication
The rate of adverse events happening [12months]
Similarly, adverse events will also be measured by the Likert scale.
The rate of good compliance [12months]
The rate of good compliance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged 18-70 with H. pylori infection.
Patients with previous Helicobacter pylori eradication.
Patients Allergic to Penicillin.

Exclusion Criteria:

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.