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

NCT ID: NCT06739382

Last Updated: 2024-12-18

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-01-01

Brief Summary

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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 ?

Detailed Description

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Conditions

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Ventilation Acquired Pneumonia

Keywords

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ventilator-associated pneumonia pandrug-resistant extensively drug-resistant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

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.

Group Type OTHER

Control group received standard therapy

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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

Intervention Type COMBINATION_PRODUCT

Control group received standard therapy

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

Intervention Type OTHER

Eligibility Criteria

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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.

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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Hasnaa Osama

Beni-Suef University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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code MS-280-2020

Identifier Type: -

Identifier Source: org_study_id