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Enrolling by Invitation

NCT Number: NCT07203638

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

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha university hospital

Banhā, Al-Qalyubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Beta Lactam Antibiotics

Drug

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

Other names: Cefipim

Salin

Drug

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

Other names: Placebo comparator

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Esraa Salah Mohamed Abdallah Eladl

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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