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

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

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 ?

Study Overview

• Status: Completed
• Conditions: Ventilation Acquired Pneumonia
• Intervention / Treatment: Combination product: extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin.; Combination product: two β-lactam antibiotics plus a single non-β-lactam antibiotic; Other: Control group received standard therapy

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: extended meropenem infusion in combination with other options; a) Patients treatment was modified to extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin	Combination product: extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin.; 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.
Active Comparator: two β-lactam antibiotics plus a single non-β-lactam antibiotic; b) Patient 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	Combination product: two β-lactam antibiotics plus a single non-β-lactam antibiotic; 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
Other: c) Patients treatment was adjusted to the second-line empirical antibiotic; c) Control group in which patients treatment was adjusted to the second-line empirical anti-biotic according to the hospital's local policy.	Other: Control group received standard therapy; Treatment was adjusted to the second-line empirical antibiotic according to the hospital's local policy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antimicrobial susceptibility	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.	7 days

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: ventilator-associated pneumonia; pandrug-resistant; extensively drug-resistant
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Synthesis Inhibitors; Antitubercular Agents; Tigecycline; Meropenem; Ertapenem; Beta Lactam Antibiotics; Amikacin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Lactams; beta-Lactams; Polymyxins
• Other Study ID Numbers: code MS-280-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes