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Completed

NCT Number: NCT06739382

Management of Ventilation Acquired Pneumonia Caused by Pseudomonas and Acinetobacter Organisms in a Pediatric Center

The goal of this clinical trial is to determine the most effective empirical therapy of antibiotics for better ventilator-associated pneumonia control. The main question it aims to answer is:

• Which is better for clinical response single or combination empiric antibiotic therapies ?

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Key information

Conditions

Ventilation Acquired Pneumonia 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

1 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pediatric Intensive Care Unit (PICU) at Cairo University's Faculty of Medicine

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-Patients ranging from one month to twelve years old, who had been undergoing mechanical ventilation for over 48 hours and were diagnosed with Ventillator Associated Pneumonia.

2.1.3. Exclusion criteria:

  • Patients with pneumonia prior to mechanical ventilation initiation.
  • Patients who had been intubated for more than 24 hours before admission to the PICU, or those transferred from other PICUs and were already receiving antibiotic therapy.

Treatment and study plan

extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin.

Combination Product

In the case of XDR or PDR Pseudomonas spp. or Acinetobacter spp. isolation from the patient's specimen, treatment was adjusted to extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin in group (A) of patients.

two β-lactam antibiotics plus a single non-β-lactam antibiotic

Combination Product

In the case of XDR or PDR Pseudomonas spp. or Acinetobacter spp. isolation from the patient's specimen, treatment was adjusted to include two β-lactam antibiotics plus a single non-β-lactam antibiotic, or a combination of double β-lactam antibiotics, with the aim of avoiding aggressive and toxic antibiotics in group (B) of patients

Control group received standard therapy

Other

Treatment was adjusted to the second-line empirical antibiotic according to the hospital's local policy.

Primary outcomes

  1. Antimicrobial susceptibility

    Time frame: 7 days

    Antimicrobial susceptibility was assessed through Kirby-Bauer's disc diffusion method (DD), Minimal Inhibitory Concentration (MIC) using the automated VITEK 2 compact system (bioMérieux, France), and the Ameri-Ziaei Double Antibiotic Synergism Test (AZDAST). Interpretation of DD and MIC results followed CLSI guidelines.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Collaborators

  • Cairo University

Registry information

Official study title

Management of Ventilation Acquired Pneumonia Caused by Pseudomonas and Acinetobacter Organisms in a Pediatric Center: a Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

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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