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

NCT05035186 | Completed

• 1 other identifier: 0305083
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rates

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

Study Arms (2)

Group 1

EXPERIMENTAL

Clarithromycin based

Drug: Amoxicillin

Group 2

EXPERIMENTAL

Levofloxacin based

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

Anti-H. pylori regimens

Also known as: Clarithromycin, Levofloxacin

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University.

Alexandria, 21131, Egypt

Location

Related Publications (1)

• 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.

  PMID: 36670359 DERIVED

MeSH Terms

Interventions

Amoxicillin; Clarithromycin; Levofloxacin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Ahmed Kamal

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 5, 2021
• Study Start: March 21, 2021
• Primary Completion: September 30, 2021
• Study Completion: November 30, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)