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

NCT ID: NCT07203638

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-11-01

Brief Summary

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

Detailed Description

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Conditions

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Ventilator-Associated Pneumonia (VAP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Efficacy of prophylactic antibiotic against vent.associated pneumonia
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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B.lactam

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

Group Type ACTIVE_COMPARATOR

Beta Lactam Antibiotics

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Salin

Intervention Type DRUG

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

Interventions

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Beta Lactam Antibiotics

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

Intervention Type DRUG

Salin

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

Intervention Type DRUG

Other Intervention Names

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Cefipim Placebo comparator

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Esraa Salah Mohamed Abdallah Eladl

OTHER

Sponsor Role lead

Responsible Party

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Esraa Salah Mohamed Abdallah Eladl

Assistant Lecturer of Critical Care Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Benha university hospital

Banhā, Al-Qalyubia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MD 1-11-2024

Identifier Type: -

Identifier Source: org_study_id

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