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

NCT ID: NCT05035186

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-21
• Study Completion Date: 2021-11-30

Brief 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.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Clarithromycin based

Group Type: EXPERIMENTAL

Amoxicillin

Intervention Type: DRUG

Anti-H. pylori regimens

Group 2

Levofloxacin based

Group Type: EXPERIMENTAL

Amoxicillin

Intervention Type: DRUG

Anti-H. pylori regimens

Interventions

Amoxicillin

Anti-H. pylori regimens

Intervention Type: DRUG

Other Intervention Names

Clarithromycin; Levofloxacin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Kamal

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Kamal

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

Alexandria University.

Alexandria, , Egypt

Countries

Egypt

References

Kamal A, Ghazy RM, Sherief D, Ismail A, Ellakany WI. Helicobacter pylori eradication rates using clarithromycin and levofloxacin-based regimens in patients with previous COVID-19 treatment: a randomized clinical trial. BMC Infect Dis. 2023 Jan 20;23(1):36. doi: 10.1186/s12879-023-07993-8.

Reference Type: DERIVED

PMID: 36670359 (View on PubMed)

Other Identifiers

0305083

Identifier Type: -

Identifier Source: org_study_id