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

Sponsor

Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05129176

Collaborator

(none)

106

Enrollment

Location

Arms

11.3

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Levofloxacin Drug: Metronidazole	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 levofloxacin-tetracycline -containing and metronidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 23, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: levofloxacin-tetracycline-containing quadruple group 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 levofloxacin-tetracycline-containing quadruple regimens
Active Comparator: metronidazole-tetracycline-containing quadruple group 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 Metronidazole-tetracycline-containing quadruple regimens

Arm

Intervention/Treatment

Experimental: levofloxacin-tetracycline-containing quadruple group

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

levofloxacin-tetracycline-containing quadruple regimens

Active Comparator: metronidazole-tetracycline-containing quadruple group

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

Metronidazole-tetracycline-containing quadruple regimens

Outcome Measures

Primary Outcome Measures

Eradication rates in 2 groups [12 months]
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 [12 months]
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.
The rate of adverse events happening [12 months]
Similarly, adverse events will also be measured by the Likert scale.

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 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