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Completed

NCT Number: NCT05035186

Efficacy of Clarithromycin and Flouroquinolones Based Regimens in H.Pylori Eradication in Covid-19 Era

Era of COVID-19 and the related panic lead to widely spread antibiotics misuse especially for azithromycin. Cross sensitivity between azithromycin and clarithromycin can impact success rates of H. pylori treatment regimens.(1) Here we aim to explore this point in Egyptian patients.

Sample size Supposing the cure rate of clarithromycin-based regimen to levofloxacin based regimen is 69% versus 84.5% respectively. Using Medcalc, the minimal required sample size is 116 patients for each arm (type 1 error= 5%, type II error=20%). Each arm increased by 10% to compensate for drop-out. The sample size will be 135 for each arm.

Study Arms:

* Arm 1: The first group will receive (amoxicillin 1g/12 hrs, Clarithromycin 500 mg/12hrs, esomeprazole 40mg/12hrs) * Arm 2: The second group will receive (esomeprazole 40 mg/12hrs, levofloxacin 500 mg/24 hrs, and amoxicillin 1gm/12 hrs). * To confirm patient compliance, we will ask patients to bring their remaining medication and counted the rest of their pills. Patients with a compliance of <80% will be excluded from the study per protocol (PP) analysis.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University.

Alexandria, 21131, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Patients aged 18-65 years old with newly diagnosed positive H. pylori antigen in stools, urea breath test or H. pylori detected on endoscopy.

Exclusion criteria

  • • Women who are pregnant or lactating, patients previously treated with H. pylori eradication therapy, those with recent exposure to antibiotics within the previous 3 months, patients who previously underwent gastric surgery, patients with malignant neoplasms, and patients with other severe concomitant diseases like renal, hepatic impairement, heart failure NYHA class II or more, hypoalbuminemia and those with possible clinically significant drug-drug interaction with any of the study's drugs will be excluded.
  • Known allergy to antibiotics.

Treatment and study plan

Amoxicillin

Drug

Anti-H. pylori regimens

Other names: Clarithromycin, Levofloxacin

Primary outcomes

  1. H. pylori eradication rates

    Time frame: 6 weeks from end of treatment and at least 2 weeks with no administration of PPIs

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Efficacy of Clarithromycin and Flouroquinolones Based Regimens in H.Pylori Eradication in Covid-19 Era: a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2021
Registry last updated
Feb 8, 2022

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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