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Helicobacter Pylori Rescue Treatment in Patients Allergic to Penicillin

NCT ID: NCT05135182

Last Updated: 2021-11-30

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

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-28

Study Completion Date

2022-12-31

Brief Summary

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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.

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 furazolidone-tetracycline-containing and metronidazole-tetracycline-containing quadruple regimens for the rescue 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

Participants Outcome Assessors

Study Groups

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furazolidone-tetracycline-containing quadruple

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

Group Type EXPERIMENTAL

Furazolidone

Intervention Type DRUG

Furazolidone-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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Furazolidone

Furazolidone-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 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.
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 Qilu hospital

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 hosipital

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]

Xiuli Zuo

Role: CONTACT

Phone: 15588818685

Email: [email protected]

Facility Contacts

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Xiuli Zuo, MD,PhD

Role: primary

Other Identifiers

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2021-SDU-QILU-G226

Identifier Type: -

Identifier Source: org_study_id