The Prophylactic Effect of Garlic Tablets to Prevent Nosocomial Infections in Intensive Care Unit Patients.

NCT06833125 | Enrolling By Invitation Phase 3 DMC

• 1 other identifier: 0108752
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if garlic tablets works to prevent nosocomial infections in hospitalized patients in ICU. The main questions it aims to answer are: Does garlic tablets administration lower the occurence of nosocomial infections in hospitalized patients in ICU?

Conditions

Nosocomial Infection

Keywords

nosocmial infection; prophylaxis; garlic

Outcome Measures

Primary Outcomes (1)

• Occurrence of central line-associated bloodstream infections, catheter- associated urinary tract infections, surgical site infections and ventilator- associated pneumonia in the two groups (by cultures results).

  one year

Secondary Outcomes (2)

• Values of Blood white cell count, body temperature and C-reactive protein of the patient in the two groups .

  one year

• Values of Blood white cell count, body temperature and C-reactive protein of the patient in the two groups .

  one year

Other Outcomes (3)

• Antibiotics consumption as total number of vials per each antibiotic in the two groups.

  one year

• Lenghth of stay of patients in ICU (by average number of days) in the two groups

  one year

• Mortality rate of patients in the two groups

  one year

Study Arms (2)

The intervention group

EXPERIMENTAL

The patients in the intervention group which will receive garlic tablets (Tomex plus 300 mg) two tablets twice daily for 6 days just after ICU admission

Drug: Garlic powder standardized to allicin

The control group

NO INTERVENTION

The patients in the control group which will not receive the garlic tablets.

Interventions

Garlic powder standardized to allicin DRUG

The intervention is the administration of garlic tablets (Tomex plus 300 mg) two tablets twice daily (which contains 5.4 mg allicin the active ingredient with anibacterial effect) for 6 days just after ICU admission

The intervention group

Eligibility Criteria

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

You may qualify if:

• All patients aged from 18 to 65 years old admitted to intensive care units without any type of infection.

You may not qualify if:

• Patients with signs /symptoms of infection.
• Patients with human immunodeficiency virus, malignancy and patients with a history of recent immunosuppressants or corticosteroids administration.
• Patients with bleeding disorders or abnormal coagulation profile
• Patients who will planned for surgery within 2 weeks.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Main University Hospital

Alexandria, Alexandria Governorate, 21563, Egypt

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a randomized non blinded controlled trial. Eligible patients will be randomly divided into two groups: An intervention group which will receive garlic tablets (Tomex plus 300 mg) two tablets twice daily for 6 days just after ICU admission and a control group which will not receive the garlic tablets.

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-02

Locations

EG (1)