search
Back to results

Tetracycline Versus Doxycycline for HP Rescue Therapy

Primary Purpose

Helicobacter Pylori Infection

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Rabeprazole
Bismuth potassium citrate
Metronidazole
Doxycycline
Tetracycline
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
  • 18-75 years old on the day of signing the ICF.
  • Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
  • Have failed eradication treatment before.

Exclusion Criteria:

  • Have not received Hp eradication treatment.
  • Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
  • Subjects or guardians refused to participate in the trial.
  • Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
  • Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
  • Pregnant or lactating women.
  • Active peptic ulcer.
  • allergic to drugs used in the trial.
  • any other circumstances that are not suitable for recruitment.

Sites / Locations

  • Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RBMD group

RAMT group

Arm Description

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and tetracycline 0.5 g qid for 14 days

Outcomes

Primary Outcome Measures

Eradication rate of Helicobacter pylori
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).

Secondary Outcome Measures

Eradication rate of Helicobacter pylori resistant strains
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.
Eradication rate of Helicobacter pylori susceptible strains
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.

Full Information

First Posted
August 22, 2021
Last Updated
August 24, 2021
Sponsor
Shanghai Zhongshan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05018923
Brief Title
Tetracycline Versus Doxycycline for HP Rescue Therapy
Official Title
Bismuth Quadruple Therapy With Tetracycline Versus Doxycycline as Rescue Therapy for Helicobacter Pylori Infection: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized controlled clinical trial will evaluate the efficacy and safety of proton pump inhibitor, bismuth, metronidazole, and either tetracycline or doxycycline for Helicobacter pylori rescue treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RBMD group
Arm Type
Experimental
Arm Description
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days
Arm Title
RAMT group
Arm Type
Active Comparator
Arm Description
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and tetracycline 0.5 g qid for 14 days
Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Intervention Description
20mg bid
Intervention Type
Drug
Intervention Name(s)
Bismuth potassium citrate
Intervention Description
0.6g bid
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
0.4g qid
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
0.1g bid
Intervention Type
Drug
Intervention Name(s)
Tetracycline
Intervention Description
0.5g qid
Primary Outcome Measure Information:
Title
Eradication rate of Helicobacter pylori
Description
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).
Time Frame
At least 4 weeks after completion of therapy
Secondary Outcome Measure Information:
Title
Eradication rate of Helicobacter pylori resistant strains
Description
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.
Time Frame
At least 4 weeks after completion of therapy
Title
Eradication rate of Helicobacter pylori susceptible strains
Description
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.
Time Frame
At least 4 weeks after completion of therapy
Other Pre-specified Outcome Measures:
Title
Adherence rate
Description
Adherence was defined as poor when subjects took less than 80% of the total medication.
Time Frame
2 weeks during therapy
Title
Frequency of adverse events
Description
Any possible adverse events during the 14-day treatment period were recorded.
Time Frame
2 weeks during therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF). 18-75 years old on the day of signing the ICF. Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test. Have failed eradication treatment before. Exclusion Criteria: Have not received Hp eradication treatment. Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases. Subjects or guardians refused to participate in the trial. Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment. Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment. Pregnant or lactating women. Active peptic ulcer. allergic to drugs used in the trial. any other circumstances that are not suitable for recruitment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Chen, MD
Phone
86-17811921405
Email
chenqimd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taotao Liu, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Chen, MD
Phone
86-18817821405
Email
chenqimd@163.com
First Name & Middle Initial & Last Name & Degree
Taotao Liu, MD
First Name & Middle Initial & Last Name & Degree
Qi Chen, MD
First Name & Middle Initial & Last Name & Degree
Ying Fang, MD
First Name & Middle Initial & Last Name & Degree
Hao Wu, MD
First Name & Middle Initial & Last Name & Degree
Ruyuan Deng, MD
First Name & Middle Initial & Last Name & Degree
Chao Wang, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available from the principal investigator Taotao Liu at liu.taotao@zs-hospital.sh.cn, beginning 6 months and ending 5 years after the trial results were published. The study protocol and statistical analysis plan are available online from https://clinicaltrials.gov/. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
IPD Sharing Time Frame
Beginning 6 months and ending 5 years after the trial results were published.
IPD Sharing Access Criteria
All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
IPD Sharing URL
http://clinicaltrials.gov/

Learn more about this trial

Tetracycline Versus Doxycycline for HP Rescue Therapy

We'll reach out to this number within 24 hrs