Efficacy and Safety of Prophylactic Antibiotics in Preventing Ventilator-associated Pneumonia: A Randomized, Double Blind, Placebo-controlled Trial

NCT07203638 | Enrolling By Invitation DMC

• 1 other identifier: MD 1-11-2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate efficacy and safety of prophylactic antibiotics in preventing early ventilator-associated pneumonia

Conditions

Ventilator-Associated Pneumonia (VAP)

Outcome Measures

Primary Outcomes (1)

• 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

  from the 2nd to the 7th day of mechanical ventilation

Study Arms (2)

B.lactam

ACTIVE COMPARATOR

Patient recieved beta lactam iv 1gm each 12h for 2 days

Drug: Beta Lactam Antibiotics

Control group

PLACEBO COMPARATOR

patients in the control group will receive saline iv each 12h for 2 days

Drug: Salin

Interventions

Beta Lactam Antibiotics DRUG

Beta lactam cefipim infusion (20mg/kg -12h -2 days ) total volume 10 ml

Also known as: Cefipim

B.lactam

Salin DRUG

Patient will receive .9 % saline (10ml /12h/2days)

Also known as: Placebo comparator

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years or older
• Both sexes will be included.
• Invasive mechanical ventilation

You may not qualify if:

• 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

Sponsors & Collaborators

• Esraa Salah Mohamed Abdallah Eladl: lead

Study Sites (1)

Benha university hospital

Banhā, Al-Qalyubia, 13511, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

beta Lactam Antibiotics

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Bacterial Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Critical Care Medicine

Model Details: Efficacy of prophylactic antibiotic against vent.associated pneumonia

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 2, 2025
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

EG (1)