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

NCT06739382 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: code MS-280-2020
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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 ?

Conditions

Ventilation Acquired Pneumonia

Keywords

ventilator-associated pneumonia; pandrug-resistant; extensively drug-resistant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

extended meropenem infusion in combination with other options

ACTIVE COMPARATOR

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.

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

ACTIVE COMPARATOR

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

c) Patients treatment was adjusted to the second-line empirical antibiotic

OTHER

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

Interventions

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.

extended meropenem infusion in combination with other options

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

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

Control group received standard therapy OTHER

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

c) Patients treatment was adjusted to the second-line empirical antibiotic

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead
• Cairo University: collaborator

Study Sites (1)

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

Cairo, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Polymyxins; Tigecycline; Ertapenem; Amikacin

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)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbapenems; beta-Lactams; Lactams; Amides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beni-Suef University

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

EG (1)