Ventilation Acquired PneumoniaPhase 3NCT06739382
Management of Ventilation Acquired Pneumonia Caused by Pseudomonas and Acinetobacter Organisms in a Pediatric Center
A Phase 3 study testing extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin. and two β-lactam antibiotics plus a single non-β-lactam antibiotic in people with Ventilation Acquired Pneumonia, run by Beni-Suef University at 1 site in Egypt.
Trial 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 ? Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Ventilation Acquired Pneumonia
- What is being tested?
- extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin. and two β-lactam antibiotics plus a single non-β-lactam antibiotic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Intensive Care Unit (PICU) at Cairo University's Faculty of Medicine
Cairo
About this study
Official title: 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 ?
- Conditions
- Ventilation Acquired Pneumonia
- Being tested
- 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, Control group received standard therapy
- Keywords
- ventilator-associated pneumonia, pandrug-resistant, extensively drug-resistant
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 antibioticCombination 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 therapyOther
Treatment was adjusted to the second-line empirical antibiotic according to the hospital's local policy.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Other: Control group received standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2021
- Primary completion1 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Hasnaa Osama, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739382
- Sponsor's protocol ID
- code MS-280-2020
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Ventilation Acquired Pneumonia Caused by Pseudomonas and Acinetobacter Organisms in a Pediatric Center: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06739382
- Acronym / sponsor ID
- code MS-280-2020
- Conditions
- Ventilation Acquired Pneumonia
- Keywords
- ventilator-associated pneumonia, pandrug-resistant, extensively drug-resistant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| extended meropenem infusion in combination with other options | Active comparator | Combination Product: extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin.a) Patients treatment was modified to 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 | Combination Product: two β-lactam antibiotics plus a single non-β-lactam antibioticb) 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 |
| c) Patients treatment was adjusted to the second-line empirical antibiotic | Other | Other: Control group received standard therapyc) Control group in which patients treatment was adjusted to the second-line empirical anti-biotic according to the hospital's local policy. |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- -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.
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | extended meropenem infusion in combination with other options |
| two β-lactam antibiotics plus a single non-β-lactam antibioticIn 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 | Combination product | two β-lactam antibiotics plus a single non-β-lactam antibiotic |
| Control group received standard therapyTreatment was adjusted to the second-line empirical antibiotic according to the hospital's local policy. | Other | c) Patients treatment was adjusted to the second-line empirical antibiotic |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
Related trials for Ventilation Acquired Pneumonia
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Recruiting
Noninvasive Support Methods for Acute Respiratory Failure of Community-acquired Pneumonia
Community-acquired Pneumonia, Community-Acquired Infections
Not yet recruiting
Resistance-Optimised Antimicrobial Dosing in Critically Ill Patients, a Randomised Controlled Trial
Hospital-acquired Pneumonia (HAP), Ventilator-Associated Pneumonia (VAP)
RecruitingObservational study
Perpetual Observational Study - Ventilator Associated Pneumonia
Ventilator Associated Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing extended meropenem infusion in combination with other options such as Polymyxin, Tigecycline, Ertapenem, or Amikacin. and two β-lactam antibiotics plus a single non-β-lactam antibiotic in people with Ventilation Acquired Pneumonia, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial susceptibility (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.