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

NCT ID: NCT05129176

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-23

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Helicobacter Pylori Infection

Keywords

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Helicobacter pylori Eradication Allergic Penicillin Tetracycline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Levofloxacin

Intervention Type DRUG

levofloxacin-tetracycline-containing quadruple regimens

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

Group Type ACTIVE_COMPARATOR

Metronidazole

Intervention Type DRUG

Metronidazole-tetracycline-containing quadruple regimens

Interventions

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Levofloxacin

levofloxacin-tetracycline-containing quadruple regimens

Intervention Type DRUG

Metronidazole

Metronidazole-tetracycline-containing quadruple regimens

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Xiuli Zuo

Professor, Director of gastroenterology department of Qiluhospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiuli Zuo, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Qilu hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiuli Zuo, MD,PhD

Role: CONTACT

Phone: 15588818685

Email: [email protected]

Facility Contacts

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Xiuli Zuo, PhD,MD

Role: primary

Other Identifiers

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2021-SDU-QILU-G709

Identifier Type: -

Identifier Source: org_study_id