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

Beni-Suef University

Status and phase: Completed; Phase 3

Conditions: Ventilation Acquired Pneumonia

Treatments: Combination Product: two β-lactam antibiotics plus a single non-β-lactam antibiotic; Combination Product: extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin.; Other: Control group received standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06739382

code MS-280-2020

Details and patient eligibility

About

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 ?

Enrollment: 64 patients

Sex: All

Ages: 1 month to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 3 patient groups

extended meropenem infusion in combination with other options

Active Comparator group

Description:

a) Patients treatment was modified to extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin

Treatment:

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 group

Description:

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

Treatment:

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 group

Description:

c) Control group in which patients treatment was adjusted to the second-line empirical anti-biotic according to the hospital's local policy.

Treatment:

Other: Control group received standard therapy