Ventilator-Associated Pneumonia (VAP)NCT07203638
Efficacy and Safety of Prophylactic Antibiotics in Preventing Ventilator-associated Pneumonia: A Randomized, Double Blind, Placebo-controlled Trial
A study testing Beta Lactam Antibiotics and Salin in people with Ventilator-Associated Pneumonia (VAP), run by Esraa Salah Mohamed Abdallah Eladl at 1 site in Egypt.
Trial summary
Evaluate efficacy and safety of prophylactic antibiotics in preventing early ventilator-associated pneumonia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventilator-Associated Pneumonia (VAP)
- What is being tested?
- Beta Lactam Antibiotics and Salin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Nov 2025
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age > 18 years or older
- Both sexes will be included.
- Invasive mechanical ventilation
Who cannot join
- ongoing pneumonia or gross aspiration confirmed by the presence of lung infiltrates on chest radiographs at admission before invasive ventilation
- previous lung disease precluding accurate interpretation of chest radiographs
- ongoing antibiotic therapy or during the week before admission
- known chronic colonization with multidrug-resistant bacteria
- known allergy to beta-lactam antibiotics
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Evaluate efficacy and safety of prophylactic antibiotics in preventing early ventilator-associated pneumonia
- Conditions
- Ventilator-Associated Pneumonia (VAP)
- Being tested
- Beta Lactam Antibiotics, Salin
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta Lactam AntibioticsDrug
Also called Cefipim
Beta lactam cefipim infusion (20mg/kg -12h -2 days ) total volume 10 ml
SalinDrug
Also called Placebo comparator
Patient will receive .9 % saline (10ml /12h/2days)
| Study group | Role | What they receive |
|---|---|---|
| B.lactam | Active comparator | Patient recieved beta lactam iv 1gm each 12h for 2 days Receives: Drug: Beta Lactam Antibiotics |
| Control group | Placebo comparator | patients in the control group will receive saline iv each 12h for 2 days Receives: Drug: Salin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation associated pneumonia
The primary outcome is the proportion of patients who will develop VAP (radiology, TLC, temperature, hemodynamic, sputum culture )from the 2nd to the 7th day of mechanical ventilation
Measured: from the 2nd to the 7th day of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Nov 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated Pneumonia (VAP)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Efficacy of prophylactic antibiotic against vent.associated pneumonia
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esraa Salah Mohamed Abdallah Eladl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esraa Salah Mohamed Abdallah Eladl, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203638
- Sponsor's protocol ID
- MD 1-11-2024
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Prophylactic Antibiotics in Preventing Ventilator-associated Pneumonia: A Randomized, Double Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07203638
- Acronym / sponsor ID
- MD 1-11-2024
- Conditions
- Ventilator-Associated Pneumonia (VAP)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Esraa Salah Mohamed Abdallah EladlUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 2 Oct 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.
Evaluate efficacy and safety of prophylactic antibiotics in preventing early ventilator-associated pneumonia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Efficacy of prophylactic antibiotic against vent.associated pneumonia
| Arm | Type | Receives |
|---|---|---|
| B.lactam | Active comparator | Drug: Beta Lactam AntibioticsPatient recieved beta lactam iv 1gm each 12h for 2 days |
| Control group | Placebo comparator | Drug: Salinpatients in the control group will receive saline iv each 12h for 2 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age > 18 years or older
Key exclusion criteria (6 listed)
- ongoing pneumonia or gross aspiration confirmed by the presence of lung infiltrates on chest radiographs at admission before invasive ventilation
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 |
|---|---|---|
| Beta Lactam AntibioticsAlso: CefipimBeta lactam cefipim infusion (20mg/kg -12h -2 days ) total volume 10 ml | Drug | B.lactam |
| SalinAlso: Placebo comparatorPatient will receive .9 % saline (10ml /12h/2days) | Drug | Control group |
Primary outcome
Ventilation associated pneumonia
Time frame: from the 2nd to the 7th day of mechanical ventilation
The primary outcome is the proportion of patients who will develop VAP (radiology, TLC, temperature, hemodynamic, sputum culture )from the 2nd to the 7th day of mechanical ventilation
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 2 Oct 2025.
Related trials for Ventilator-Associated Pneumonia (VAP)
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Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
Ventilator Associated Pneumonia ( VAP)
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 study testing Beta Lactam Antibiotics and Salin in people with Ventilator-Associated Pneumonia (VAP), run by Esraa Salah Mohamed Abdallah Eladl 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 3 inclusion and 6 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 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Ventilation associated pneumonia (time frame: from the 2nd to the 7th day of mechanical ventilation). 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 2 Oct 2025.