RCT: Eradication of H. Pylori Infection With Moxifloxacin

• Sponsor: Iyad Naeem Muhammad, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT05863858
• Collaborator: (none)
• Enrollment: 162
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.2
• Patients Per Site Per Month: 6.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection; Helicobacter Pylori Infection, Susceptibility to	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	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: High Eradication Rate of Helicobacter Pylori Infection With Moxifloxacin-Based Triple Therapy in Comparison With Levofloxacin-Based Sequential Therapy: Randomized Controlled Trials
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Dec 1, 2021
• Actual Study Completion Date: Jun 8, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Helicobacter pylori status one month after treatment. [One month after finishing with therapy.]

   Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.

Secondary Outcome Measures

1. Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection. [One month after finishing with therapy.]

   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

2. Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection. [One month after finishing with therapy.]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jamal Noor Hospital, Karachi	Karachi	Sindh	Pakistan	74800

Sponsors and Collaborators

• Iyad Naeem Muhammad, PhD

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Iyad Naeem Muhammad, PhD, Associate Professor, University of Karachi
• ClinicalTrials.gov Identifier: NCT05863858
• Other Study ID Numbers: RCT-HP-01
• First Posted: May 18, 2023
• Last Update Posted: May 18, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Iyad Naeem Muhammad, PhD, Associate Professor, University of Karachi: Triple therapy with moxifloxacin; Helicobacter pylori; Levofloxacin sequential therapy; Stool Antigen test
• Additional relevant MeSH terms: Infections; Communicable Diseases; Helicobacter Infections; Disease Susceptibility; Amoxicillin; Moxifloxacin; Levofloxacin; Ofloxacin; Tinidazole; Omeprazole; Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of May 18, 2023