Back to resultsEradication of H. Pylori Infection With Moxifloxacin (RCT)
Primary Purpose
Helicobacter Pylori Infection, Helicobacter Pylori Infection, Susceptibility to
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID
Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Triple therapy with moxifloxacin, Helicobacter pylori, Levofloxacin sequential therapy, Stool Antigen test
Eligibility Criteria
Inclusion Criteria: Successful isolation of H. pylori from the patient, and patients of at least 18 years of age. Exclusion Criteria: age under 18 years presence of clinically significant associated conditions (insulin-dependent diabetes mellitus, gastrointestinal bleeding, neoplastic diseases, coagulation disorders, and neurologic, metabolic, hematological or endocrine hepatic, cardiorespiratory, or renal diseases), previous gastric surgery, allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.
Sites / Locations
- Jamal Noor Hospital, Karachi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Levofloxacin-based sequential Therapy
Moxifloxacin-based Triple Therapy
Arm Description
Tablets Levofloxacin 500mg BID for the first five days Tablet Amoxicillin 1 gm BID for first five days Capsules Omeprazole 20 mg BID for first five days followed by 1. Tablet Levofloxacin 500 mg BID for five days 2. Tablet Tinidazole 500mg BID for five days 3. Capsule Omeprazole 20 mg BID for five days Infection eradication will be observed and confirmed by stool antigen test correlated with the signs and symptoms
Tablet Moxifloxacin 400 mg OD for ten days Tablet Amoxicillin 1 gm BID for ten days Capsule Omeprazole 20 mg BID for ten days Infection eradication will be observed and confirmed with a stool antigen test along with patient compliance and tolerability observance.
Outcomes
Primary Outcome Measures
Helicobacter pylori status one month after treatment.
Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.
Secondary Outcome Measures
Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.
Compliance will be measured by counting pills that were taken during therapy. More than or equal 80 % of taken pills will be consider as good compliance
Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.
Patients will be asked to report any adverse effect that occurred during treatment. They will be divided into groups according to the degree of limiting daily activities: no adverse effects; mild (no limit of activities); moderate (partially limited activities); severe (completely limited activities).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05863858
Brief Title
Eradication of H. Pylori Infection With Moxifloxacin
Acronym
RCT
Official Title
High Eradication Rate of Helicobacter Pylori Infection With Moxifloxacin-Based Triple Therapy in Comparison With Levofloxacin-Based Sequential Therapy: Randomized Controlled Trials
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
June 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Iyad Naeem Muhammad, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance.
Detailed Description
Patients who were confirmed to be positive for Helicobacter Pylori infection were randomly assigned to the eradication treatments. At four weeks after completion of eradication therapy, H. pylori tests were performed with a Stool antigen test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Helicobacter Pylori Infection, Susceptibility to
Keywords
Triple therapy with moxifloxacin, Helicobacter pylori, Levofloxacin sequential therapy, Stool Antigen test
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomized into two regimens:
Levofloxacin 500mg BID, Amoxicillin 1 gm BID, Omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mg BID, Tinidazole 500mg BID, Omeprazole 20 mg BID, or
Moxifloxacin 400 mg OD, Amoxicillin 1 gm BID, Omeprazole 20 mg BID.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levofloxacin-based sequential Therapy
Arm Type
Active Comparator
Arm Description
Tablets Levofloxacin 500mg BID for the first five days
Tablet Amoxicillin 1 gm BID for first five days
Capsules Omeprazole 20 mg BID for first five days followed by
1. Tablet Levofloxacin 500 mg BID for five days 2. Tablet Tinidazole 500mg BID for five days 3. Capsule Omeprazole 20 mg BID for five days
Infection eradication will be observed and confirmed by stool antigen test correlated with the signs and symptoms
Arm Title
Moxifloxacin-based Triple Therapy
Arm Type
Active Comparator
Arm Description
Tablet Moxifloxacin 400 mg OD for ten days
Tablet Amoxicillin 1 gm BID for ten days
Capsule Omeprazole 20 mg BID for ten days
Infection eradication will be observed and confirmed with a stool antigen test along with patient compliance and tolerability observance.
Intervention Type
Drug
Intervention Name(s)
Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID
Other Intervention Name(s)
Levofloxacin, Amoxicillin, Omeprazole, Tinidazole
Intervention Description
The eradication rate of H. Pylori with levofloxacin-based sequential therapy
Intervention Type
Drug
Intervention Name(s)
Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID
Other Intervention Name(s)
Moxifloxacin, Amoxicillin, Omeprazole
Intervention Description
The eradication rate of H. Pylori with moxifloxacin-based triple therapy
Primary Outcome Measure Information:
Title
Helicobacter pylori status one month after treatment.
Description
Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.
Time Frame
One month after finishing with therapy.
Secondary Outcome Measure Information:
Title
Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.
Description
Compliance will be measured by counting pills that were taken during therapy. More than or equal 80 % of taken pills will be consider as good compliance
Time Frame
One month after finishing with therapy.
Title
Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.
Description
Patients will be asked to report any adverse effect that occurred during treatment. They will be divided into groups according to the degree of limiting daily activities: no adverse effects; mild (no limit of activities); moderate (partially limited activities); severe (completely limited activities).
Time Frame
One month after finishing with therapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Successful isolation of H. pylori from the patient, and
patients of at least 18 years of age.
Exclusion Criteria:
age under 18 years
presence of clinically significant associated conditions (insulin-dependent diabetes mellitus, gastrointestinal bleeding, neoplastic diseases, coagulation disorders, and neurologic, metabolic, hematological or endocrine hepatic, cardiorespiratory, or renal diseases),
previous gastric surgery,
allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iyad N Muhammad, Ph.D.
Organizational Affiliation
Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jamal Noor Hospital, Karachi
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared and made available for other researchers after due coding. The data will be summarized and tabulated in the thesis and article manuscripts. The IPD would include the basic information and demographic data, the treatment protocols, informed consent, and the outcome measures data.
IPD Sharing Time Frame
The data will be shared and made permanently available on the formats mentioned above by January 2024.
IPD Sharing Access Criteria
The data will be shared by the researches in RCT, working on H. pylori therapy or diagnosis. Communication would be electronically made through emails.
Citations:
PubMed Identifier
25547786
Citation
Rakici H, Ayaz T, Akdogan RA, Bedir R. Comparison of levofloxacin- and moxifloxacin-based triple therapies with standard treatment in eradication of Helicobacter pylori as first-line therapy. Digestion. 2014;90(4):261-4. doi: 10.1159/000369788. Epub 2014 Dec 24.
Results Reference
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PubMed Identifier
32351290
Citation
Mori H, Suzuki H. Update on quinolone-containing rescue therapies for Helicobacter pylori infection. World J Gastroenterol. 2020 Apr 21;26(15):1733-1744. doi: 10.3748/wjg.v26.i15.1733.
Results Reference
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PubMed Identifier
34390083
Citation
Hsu PI, Tsay FW, Kao JY, Peng NJ, Chen YH, Tang SY, Kuo CH, Kao SS, Wang HM, Wu IT, Shie CB, Chuah SK, Wu DC; Taiwan Acid-related Disease, Microbiota (TARD-M) Consortium. Tetracycline-levofloxacin versus amoxicillin-levofloxacin quadruple therapies in the second-line treatment of Helicobacter pylori infection. Helicobacter. 2021 Oct;26(5):e12840. doi: 10.1111/hel.12840. Epub 2021 Aug 12.
Results Reference
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PubMed Identifier
26401089
Citation
Hwang JJ, Lee DH, Yoon H, Shin CM, Park YS, Kim N. Efficacy of moxifloxacin-based sequential and hybrid therapy for first-line Helicobacter pylori eradication. World J Gastroenterol. 2015 Sep 21;21(35):10234-41. doi: 10.3748/wjg.v21.i35.10234.
Results Reference
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Eradication of H. Pylori Infection With Moxifloxacin
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