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

NCT05133193 | Unknown DMC

• 1 other identifier: 2020-SDU-QILU-G057
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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 rate

  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

  6 month

Secondary Outcomes (2)

• The rates of adverse events

  6 month

• Compliance

  6 month

Study Arms (1)

14d concomitant therapy

EXPERIMENTAL

The eligible patients received 14-day concomitant therapy, including vonoprazan and three kinds of antibiotics according to the previous eradication regimens and antibiotic use. Antibiotics are selected from Amoxicillin, Tetracycline, Furazolidone, Levofloxacin, Clarithromycin, Tinidazole, Metronidazole.

Drug: three kinds of antibiotics

Interventions

three kinds of antibiotics DRUG

All patients were educated carefully about the medical instructions, including the duration of treatment, possible side effect, the necessity of completing the full 14-day course.

Also known as: antibiotics

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 years were recruited for this study if they had failed at least three rounds of anti- H. pylori therapies.

You may not qualify if:

• Patients treated with H2-receptor antagonist, PPI, vonoprazan, 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,
• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Sponsors & Collaborators

• Shandong University: lead

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

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: November 13, 2021
• First Posted: November 24, 2021
• Study Start: November 20, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 26, 2021

Record last verified: 2021-11