Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122287
• Other study ID #: 2019-SDU-QILU-G709
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: December 2022

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• 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 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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Levofloxacin
levofloxacinn-tetracycline-containing quadruple regimens
• tinidazole
tinidazole-tetracycline-containing quadruple regimens

Locations

Country	Name	City	State
China	Qilu hospital	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. 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.	24 months
Secondary	The rate of improving dyspepsia symptoms after Helicobacter pylori eradication	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.	24 months
Secondary	The rate of adverse events happening	Similarly, adverse events will also be measured by the Likert scale.	24 months
Secondary	The rate of good compliance	Patients taken over 90% of drugs are considered to have a good compliance.	24 months