Eradication of H. Pylori Infection With Moxifloxacin (RCT)

High Eradication Rate of Helicobacter Pylori Infection With Moxifloxacin-Based Triple Therapy in Comparison With Levofloxacin-Based Sequential Therapy: Randomized Controlled Trials

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection; Helicobacter Pylori Infection, Susceptibility to
• Intervention / Treatment: Drug: 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; Drug: Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID

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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Jamal Noor Hospital, Karachi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Successful isolation of H. pylori from the patient, and
2. patients of at least 18 years of age.

Exclusion Criteria:

1. age under 18 years
2. 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),
3. previous gastric surgery,
4. allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Levofloxacin-based sequential Therapy; 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	Drug: 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; The eradication rate of H. Pylori with levofloxacin-based sequential therapy; Other Names: Levofloxacin; Amoxicillin; Omeprazole; Tinidazole
Active Comparator: Moxifloxacin-based Triple Therapy; 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.	Drug: Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID; The eradication rate of H. Pylori with moxifloxacin-based triple therapy; Other Names: Moxifloxacin; Amoxicillin; Omeprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One month after finishing with therapy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One month after finishing with therapy.
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).	One month after finishing with therapy.

Collaborators and Investigators

• Sponsor: Iyad Naeem Muhammad, PhD
• Investigators: Principal Investigator: Iyad N Muhammad, Ph.D., Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): June 8, 2022

Study Registration Dates

• First Submitted: March 25, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Triple therapy with moxifloxacin; Levofloxacin sequential therapy; Stool Antigen test
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Disease Susceptibility; Helicobacter Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Alkylating Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Amoxicillin; Omeprazole; Levofloxacin; Ofloxacin; Tinidazole
• Other Study ID Numbers: RCT-HP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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