Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03726099
• Other study ID #: 2018SDU-QILU-G004
• Status: Recruiting
• Phase: Phase 4
• Start date: March 15, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2020
• Source: Shandong University
• Contact: Xiuli Zuo, MD,PhD
• Phone: 8653182169025
• Email: qlywc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.

Description:

Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted. Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with two or more treatment failure, and then evaluates whether adverse effects are tolerable. .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-70 with persistent H. pylori infection.

• Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

Exclusion Criteria:

• Patients unable or unwilling to receive gastroscopy.

• Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.

• Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.

• History of allergy to any of the drugs used in the study.

• Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.

• Currently pregnant or lactating.

• Severe neurologic or psychiatric disorders.

• Alcohol abuse or drug addiction.

• Patients with compliance lower than 90% in any previous treatment are not included.

• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• esomeprazole, amoxicillin, furazolidone,tetracycline
Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day concomitant therapy containing esomeprazole 40mg bid, amoxicillin 1000mg bid , furazolidone 100mg bid and tetracycline 500mg qid.

Locations

Country	Name	City	State
China	Xiuli Zuo	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	Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all the 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.	6 months
Secondary	The rate of adverse events happening	Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.	6 months
Secondary	Changes of dyspepsia symptoms after Helicobacter pylori eradication	A list of dyspepsia symptoms will be recorded. Difference of dyspepsia symptoms before and after the therapy will be compared.	6 months
Secondary	The rate of good compliance	Patients taken over 90% of drugs are considered to have a good compliance.	6 months