- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07421440
Flexible Bronchoscopy in Resistant Pneumonia in PICU (FFP-RP PICU)
Outcome of Flexible Fiber Optic Bronchoscopy Usage in Children With Resistant Pneumonia in Pediatric Intensive Care Units (PICU )
Pneumonia is one of the most common and serious infections in children, especially those admitted to Pediatric Intensive Care Units (PICUs). Some children do not improve after at least five days of appropriate broad-spectrum antibiotic treatment. This condition is known as resistant or non-resolving pneumonia.
Flexible fiberoptic bronchoscopy (FFB) is a procedure that allows doctors to directly examine the airways and collect samples from the lungs for laboratory testing. This study aims to evaluate the role and usefulness of flexible bronchoscopy and bronchoalveolar lavage (BAL) in identifying the causes of resistant pneumonia in critically ill children.
The study will include children admitted to the PICU at Abu El-Reesh Children's Hospital, Cairo University, who show no clinical or radiological improvement after five days of first-line antibiotic therapy. The results of this study may help improve diagnosis, guide targeted treatment, and enhance outcomes in children with resistant pneumonia.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Cairo Governorate
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Cairo, Cairo Governorate, Egypt, 11562
- faculty of medicine , Abu Elreesh children hospital
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Cairo, Cairo Governorate, Egypt
- faculty of medicine , Abu Elreesh children hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- - Children aged more than 3 months and less than 18 years.
- Admitted to Pediatric Intensive Care Unit (PICU).
Severe pneumonia defined as cough or difficulty breathing with at least one of the following:
- Oxygen saturation < 90% on pulse oximetry
- Severe respiratory distress
- General danger signs (inability to drink, lethargy, convulsions)
- No clinical or radiological improvement after at least five days of first-line broad-spectrum antibiotic therapy.
- Informed consent obtained from parent or legal guardian.
Exclusion Criteria:
- Age less than 3 months or more than 18 years.
- Absolute contraindication to flexible bronchoscopy (severe refractory hypoxemia, hemodynamic instability, uncorrected bleeding disorder).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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resistant pneumonia patients
Children admitted to the Pediatric Intensive Care Unit (PICU) with severe pneumonia who show no clinical or radiological improvement after at least five days of first-line broad-spectrum antibiotic therapy and undergo flexible fiberoptic bronchoscopy for diagnostic evaluation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diagnostic yield of flexible fiberoptic bronchoscopy (FFB) in resistant pneumonia
Time Frame: Within 7 days after bronchoscopy procedure
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Proportion of patients in whom flexible fiberoptic bronchoscopy with bronchoalveolar lavage identifies a specific etiological pathogen (bacterial, viral, or fungal) responsible for resistant pneumonia
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Within 7 days after bronchoscopy procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of resistant pneumonia in PICU
Time Frame: Within 7 days after bronchoscopy procedure
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Percentage of pediatric intensive care unit patients diagnosed with resistant pneumonia among total admitted pneumonia cases during the study period.
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Within 7 days after bronchoscopy procedure
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD-207-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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