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

NCT04991584 | Unknown DMC

• 1 other identifier: 2021-SDU-QILU-G003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Keywords

Concomitant Therapy; Rescue treatment

Outcome Measures

Primary Outcomes (1)

• Eradication rates

  Six weeks after completion of treatment,number of patients get H.pylori eradicated will be investigated.Then eradication rate will be calculated by using intention-to-treat analysis and per-protocol analysis. results will be investigated by an independent researcher.Then eradication rate in each group will be calculated by using intention-to-treat analysis and per-protocol analysis. 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 month

Secondary Outcomes (2)

• The rate of adverse events happening

  6 month

• Compliance of patients

  6 month

Study Arms (1)

14d concomitant therapy

EXPERIMENTAL

Patients will receive a 14-day concomitant therapy Option 1:Amoxicillin+Tetracycline+Furazolidone+Vonoprazan fumarate or Esomeprazole Option 2: Amoxicillin+Furazolidone+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 3: Amoxicillin+Tetracycline+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 4: Amoxicillin+Clarithromycin+Levofloxacin+Vonoprazan fumarate or Esomeprazole Three options are selected according to the actual situation.

Drug: Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole ,

Interventions

Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole , DRUG

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.

14d concomitant therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hospital

Jinan, Shandong, 250000, China

Location

MeSH Terms

Interventions

Amoxicillin; Esomeprazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: August 5, 2021
• Study Start: August 4, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 1, 2022
• Last Updated: August 5, 2021

Record last verified: 2021-08

Locations

CN (1)