Safety and Efficacy of Triple and Quadruple Regimens as First Line Therapy for Management of Helicobacter Pylori Infection in Egyptians

NCT06315478 | Completed Phase 4

• 1 other identifier: Hybrid regimen for H.pylori
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Our study aimed to investigate the efficacy and safety of hybrid regimen as a first line therapy for H. pylori eradication compared to triple and quadruple regimens in attempt to overcome antibiotic resistance

Conditions

H.Pylori Infection

Outcome Measures

Primary Outcomes (1)

• stool antigen retest

  efficacy of the regimen by eradication of H. pylori

  6 weeks

Study Arms (3)

Triple regimen(Group A)

ACTIVE COMPARATOR

Drug: Omeprazole 20 MG Oral Tablet

Quadruple regimen (Group B)

ACTIVE COMPARATOR

Drug: Amoxicillin 500Mg Tab

Hybrid regimen (Group C)

ACTIVE COMPARATOR

Drug: Clarithromycin 500Mg Tab

Interventions

Omeprazole 20 MG Oral Tablet DRUG

standard triple therapy for 14 days Bid for each drug

Also known as: amoxicillin 500 mg, clarithromycin 500mg

Triple regimen(Group A)

Amoxicillin 500Mg Tab DRUG

Quadruple regimen for 14 days Bid for each drug

Also known as: Omeprazole 20 MG Oral Tablet, clarithromycin 500mg, metronidazole 500mg

Quadruple regimen (Group B)

Clarithromycin 500Mg Tab DRUG

Hybrid regimen, PPI and Amoxicillin for first 7 days then adding clarithromycin and metronidazole for the second 7 days

Also known as: amoxicillin 500 mg Tablet, Omeprazole 20 MG Oral Tablet, metronidazole 500mg Tablet

Hybrid regimen (Group C)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Naïve patients 2. adult \>18 years 3. Patients with positive SAT 4. Patients didn't take any antibiotics for the previous 4 weeks or PPI for the previous 2 weeks 5. Patients diagnosed with duodenal ulcers who have H. pylori infection and treated with triple or quadruple regimens for H. pylori

You may not qualify if:

• Patients had any concern with triple or quadruple regimens such as hypersensitivity to any of the drug 2-Pregnancy or lactation 3-Refusal to sign the informed consent.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Badr hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

Omeprazole; Tablets; Amoxicillin; Clarithromycin; Metronidazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: bachelor graduate at pharmacy university

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: February 1, 2021
• Primary Completion: March 16, 2021
• Study Completion: November 1, 2021
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)