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Completed

NCT Number: NCT05863858

Eradication of H. Pylori Infection With Moxifloxacin

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.

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Key information

Conditions

Helicobacter Pylori Infection Helicobacter Pylori Infection, Susceptibility to

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jamal Noor Hospital, Karachi

Karachi, Sindh, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: Levofloxacin, Amoxicillin, Omeprazole, Tinidazole

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

Drug

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

Other names: Moxifloxacin, Amoxicillin, Omeprazole

Primary outcomes

  1. Helicobacter pylori status one month after treatment.

    Time frame: 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 outcomes

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

    Time frame: 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.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Iyad Naeem Muhammad, PhD

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 18, 2023
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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