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

Primary Purpose

Helicobacter Pylori Infection

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

three kinds of antibiotics

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Concomitant Therapy,Rescue treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged 18-70 years were recruited for this study if they had failed at least three rounds of anti- H. pylori therapies.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

14d concomitant therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The rates of adverse events

At the follow-up,adverse events complained by patients will be recorded by an inde pendent researcher, meanwhile a 8point visual analog scale (VAS) was used to evaluate severity of adverse events.

Compliance

Compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken.

Full Information

NCT ID

NCT05133193

First Posted

November 13, 2021

Last Updated

November 24, 2021

Sponsor

Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT05133193

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 20, 2021 (Anticipated)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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 three or more treatment failure, and then evaluates whether adverse effects are tolerable. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Helicobacter Pylori Infection

Keywords

Concomitant Therapy,Rescue treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

14d concomitant therapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

three kinds of antibiotics

Other Intervention Name(s)

antibiotics

Intervention Description

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.

Primary Outcome Measure Information:

Title

Eradication rate

Description

Time Frame

6 month

Secondary Outcome Measure Information:

Title

The rates of adverse events

Description

At the follow-up,adverse events complained by patients will be recorded by an inde pendent researcher, meanwhile a 8point visual analog scale (VAS) was used to evaluate severity of adverse events.

Time Frame

6 month

Title

Compliance

Description

Compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken.

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged 18-70 years were recruited for this study if they had failed at least three rounds of anti- H. pylori therapies. Exclusion Criteria: 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.

12. IPD Sharing Statement

Learn more about this trial

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

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