Eradication of H. Pylori Infection With Moxifloxacin

Phase 3

Completed

• Conditions: Helicobacter Pylori Infection; Helicobacter Pylori Infection, Susceptibility to

• Registration Number: NCT05863858
• Lead Sponsor: Iyad Naeem Muhammad, PhD

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-08
• Study First Submitted: 2023-03-25
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-08
• Last Update Submitted: 2023-05-08
• Study First Posted: 2023-05-18
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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

Trial Locations

Locations (1)

Jamal Noor Hospital, Karachi; 🇵🇰 Karachi, Sindh, Pakistan