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NCT05135182 Clinical Trial

Helicobacter Pylori Rescue Treatment in Patients Allergic to Penicillin

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05135182
Other study ID # 2021-SDU-QILU-G226
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 28, 2021
Est. completion date December 2022

Study information
Verified date November 2021
Source Shandong University
Contact Xiuli Zuo, MD,PhD
Phone 15588818685
Email zuoxiuli@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 170
Est. completion date December 2022
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Furazolidone
Furazolidone-tetracycline-containing quadruple regimens
• Metronidazole
metronidazole-tetracycline-containing quadruple regimens

Locations
Country Name City State
China Qilu hosipital Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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