Eradication of H. Pylori Infection With Moxifloxacin

NCT05863858 | Completed Phase 3 DMC

• 1 other identifier: RCT-HP-01
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection; Helicobacter Pylori Infection, Susceptibility to

Keywords

Triple therapy with moxifloxacin; Helicobacter pylori; Levofloxacin sequential therapy; Stool Antigen test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.

  One month after finishing with therapy.

• Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.

  One month after finishing with therapy.

Study Arms (2)

Levofloxacin-based sequential Therapy

ACTIVE COMPARATOR

1. Tablets Levofloxacin 500mg BID for the first five days 2. Tablet Amoxicillin 1 gm BID for first five days 3. 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

Moxifloxacin-based Triple Therapy

ACTIVE COMPARATOR

1. Tablet Moxifloxacin 400 mg OD for ten days 2. Tablet Amoxicillin 1 gm BID for ten days 3. 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

Interventions

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

The eradication rate of H. Pylori with levofloxacin-based sequential therapy

Also known as: Levofloxacin, Amoxicillin, Omeprazole, Tinidazole

Levofloxacin-based sequential Therapy

Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID DRUG

The eradication rate of H. Pylori with moxifloxacin-based triple therapy

Also known as: Moxifloxacin, Amoxicillin, Omeprazole

Moxifloxacin-based Triple Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iyad Naeem Muhammad, PhD: lead

Study Sites (1)

Jamal Noor Hospital, Karachi

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 25547786 BACKGROUND

• 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.

  PMID: 32351290 BACKGROUND

• 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.

  PMID: 34390083 BACKGROUND

• 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.

  PMID: 26401089 BACKGROUND

MeSH Terms

Interventions

BID protein, human; Omeprazole; Tinidazole; Levofloxacin; Amoxicillin; Moxifloxacin

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Iyad N Muhammad, Ph.D.

  Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients were randomized into two regimens: 1. 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 2. Moxifloxacin 400 mg OD, Amoxicillin 1 gm BID, Omeprazole 20 mg BID.

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: May 18, 2023
• Study Start: June 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 8, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be shared and made permanently available on the formats mentioned above by January 2024.
• 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.

Locations

PA (1)