Eradication of H. Pylori Infection With Moxifloxacin

Helicobacter Pylori Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05863858
• Other study ID #: RCT-HP-01
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2020
• Est. completion date: June 8, 2022

Study information

• Verified date: May 2023
• Source: University of Karachi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: June 8, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 signi?cant 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Disease Susceptibility
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

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
• Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID
The eradication rate of H. Pylori with moxifloxacin-based triple therapy

Locations

Country	Name	City	State
Pakistan	Jamal Noor Hospital, Karachi	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Iyad Naeem Muhammad, PhD

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.