Nosocomial InfectionPhase 3NCT06833125
The Prophylactic Effect of Garlic Tablets to Prevent Nosocomial Infections in Intensive Care Unit Patients.
A Phase 3 study testing Garlic powder standardized to allicin in people with Nosocomial Infection, run by Alexandria University at 1 site in Egypt.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nosocomial Infection
- What is being tested?
- Garlic powder standardized to allicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Apr 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged from 18 to 65 years old admitted to intensive care units without any type of infection.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Alexandria Main University Hospital
Alexandria, Alexandria Governorate, 21563
About this study
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
- Being tested
- Garlic powder standardized to allicin
- Keywords
- nosocmial infection, prophylaxis, garlic
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic powder standardized to allicinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Garlic powder standardized to allicin |
| The control group | No intervention | The patients in the control group which will not receive the garlic tablets. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one year
Secondary outcomes (2)
Values of Blood white cell count, body temperature and C-reactive protein of the patient in the two groups .
The Mean of Blood white cell count (number per micro liter) , body temperature ( by the degree Celsius) and C-reactive protein (milligrams per liter ) of the patients in the two groups will be calculated.
Measured: one year
Values of Blood white cell count, body temperature and C-reactive protein of the patient in the two groups .
The Mean of Blood white cell count, body temperature and C-reactive protein of the patient in the two groups will be calculated.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833125
- Sponsor's protocol ID
- 0108752
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prophylactic Effect of Garlic Tablets to Prevent Nosocomial Infections in Intensive Care Unit Patients.
- ClinicalTrials.gov ID
- NCT06833125
- Acronym / sponsor ID
- 0108752
- Conditions
- Nosocomial Infection
- Keywords
- nosocmial infection, prophylaxis, garlic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Drug: Garlic powder standardized to allicinThe 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 |
| The control group | No intervention | –The patients in the control group which will not receive the garlic tablets. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged from 18 to 65 years old admitted to intensive care units without any type of infection.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garlic powder standardized to allicinThe 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 | Drug | The intervention group |
Primary outcome
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).
Time frame: one year
2 secondary outcomes
Values of Blood white cell count, body temperature and C-reactive protein of the patient in the two groups .
Time frame: one year
Values of Blood white cell count, body temperature and C-reactive protein of the patient in the two groups .
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Nosocomial Infection
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Active, not recruitingObservational study
Initial and Subsequent Healthcare-Associated Infections in Intensive Care Patients
Cross Infection, Intensive Care Units
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Garlic powder standardized to allicin in people with Nosocomial Infection, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.