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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035186
• Other study ID #: 0305083
• Status: Completed
• Phase: N/A
• Start date: March 21, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: February 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: November 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Amoxicillin
Anti-H. pylori regimens

Locations

Country	Name	City	State
Egypt	Alexandria University.	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H. pylori eradication rates		6 weeks from end of treatment and at least 2 weeks with no administration of PPIs