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Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease

Primary Purpose

Helicobacter Pylori Infection, Intravenous Drug Usage

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Esomeprazole
Metronidazole
Levofloxacin
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter Pylori Infection, Intravenous Drug Usage

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female aged between 18 and 75 years old
  • Without previous Helicobacter pylori treatment
  • Diagnosed with active peptic ulcer disease and related complications like bleeding and pyloric obstruction by endoscopy examination
  • Ability and willingness to participate in the study and to sign and give informed consent
  • Positive for Helicobacter pylori IgM antibody

Exclusion Criteria:

  • With previous gastric surgery
  • Major systemic diseases
  • Pregnancy or lactation
  • Allergy to any of the study drugs
  • Decline to participate in the study

Sites / Locations

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravenous therapy

Arm Description

Subjected enrolled will receive (a) a 10-day intravenous triple therapy containing esomeprazole 40 mg thrice a day, metronidazole 500 mg twice a day and levofloxacin 500 mg once a day and (b) esomeprazole 20 mg twice a day taken orally for 8 weeks.

Outcomes

Primary Outcome Measures

Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).

Secondary Outcome Measures

Rate of adverse effects
Rate of stop bleeding
Rate of pyloric obstruction remission

Full Information

First Posted
June 11, 2020
Last Updated
August 25, 2020
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04432233
Brief Title
Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease
Official Title
Intravenous Administration of Metronidazole, Levofloxacin and Esomeprazole Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

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

5. Study Description

Brief Summary
Helicobacter pylori infection causes active peptic ulcer disease and related complications like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter pylori infection after active peptic ulcer disease and related complicaitons getting healed, which spent time and money. This study is designed to evaluate the efficacy and safety of intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in the treatment of Helicobacter pylori infection combined with peptic ulcer disease related complications.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous therapy
Arm Type
Experimental
Arm Description
Subjected enrolled will receive (a) a 10-day intravenous triple therapy containing esomeprazole 40 mg thrice a day, metronidazole 500 mg twice a day and levofloxacin 500 mg once a day and (b) esomeprazole 20 mg twice a day taken orally for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Proton pump inhibitor
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
antibiotic for H. pylori eradication
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
antibiotic for H. pylori eradication
Primary Outcome Measure Information:
Title
Helicobacter pylori eradication rate
Description
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
Time Frame
Six weeks after completion of therapy
Secondary Outcome Measure Information:
Title
Rate of adverse effects
Time Frame
Within 7 days after completion of therapy
Title
Rate of stop bleeding
Time Frame
Within 7 days after completion of therapy
Title
Rate of pyloric obstruction remission
Time Frame
Within 7 days after completion of 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: Male or female aged between 18 and 75 years old Without previous Helicobacter pylori treatment Diagnosed with active peptic ulcer disease and related complications like bleeding and pyloric obstruction by endoscopy examination Ability and willingness to participate in the study and to sign and give informed consent Positive for Helicobacter pylori IgM antibody Exclusion Criteria: With previous gastric surgery Major systemic diseases Pregnancy or lactation Allergy to any of the study drugs Decline to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Liang, PHD,MD
Phone
13120839615
Email
xliang5515@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Lu, PHD,MD
Organizational Affiliation
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Liang, PHD,MD
Phone
13120839615
Email
xliang5515@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease

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