PneumoniaFFP-RP PICUNCT07421440
Flexible Bronchoscopy in Resistant Pneumonia in PICU
An observational study of Pneumonia and Resistant Pneumonia, run by Mansour Gomaa Mohammed Saleh at 1 site in Egypt.
Trial summary
Pneumonia remains a leading cause of morbidity and mortality among critically ill children admitted to Pediatric Intensive Care Units (PICUs). A proportion of patients fail to demonstrate clinical or radiological improvement despite receiving at least five days of appropriate broad-spectrum antibiotic therapy, a… Read more about this study
- Who is it for?
- Ages 3 months to 14 years
- Conditions the study is for
- Pneumonia, Resistant Pneumonia, Resistant Pneumonia in Critically Ill Pedaitric Patients
- What is being tested?
- Flexible fiberoptic bronchoscopy with bronchoalveolar lavage (BAL)
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2023to 3 Aug 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 3 months to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 3 months to 18 years admitted to the Pediatric Intensive Care Unit at Abu El-Reesh Children's Hospital, Cairo University, with resistant pneumonia who underwent flexible fiberoptic bronchoscopy with bronchoalveolar lavage as part of their diagnostic evaluation
Who may be able to join
- - Children aged more than 3 months and less than 14 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.
Who cannot join
- Age less than 3 months or more than 14 years.
- Absolute contraindication to flexible bronchoscopy (severe refractory hypoxemia, hemodynamic instability, uncorrected bleeding disorder).
- refusal of informed consent by parents or legal guardian
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Abu Elreesh children hospital , faculty of medicine , cairo university
Cairo, Cairo Governorate
About this study
Official title: Outcome of Flexible Fiber Optic Bronchoscopy Usage in Children With Resistant Pneumonia in Pediatric Intensive Care Units (PICU )
Pneumonia remains a leading cause of morbidity and mortality among critically ill children admitted to Pediatric Intensive Care Units (PICUs). A proportion of patients fail to demonstrate clinical or radiological improvement despite receiving at least five days of appropriate broad-spectrum antibiotic therapy, a condition commonly referred to as resistant or non-resolving pneumonia. These patients often require further diagnostic evaluation to identify persistent infection, resistant microorganisms, airway abnormalities, or alternative diagnoses.
Flexible fiberoptic bronchoscopy (FFB) with bronchoalveolar lavage (BAL) is an important diagnostic procedure that permits direct visualization of the tracheobronchial tree and collection of lower respiratory tract specimens for microbiological analysis. The findings obtained through FFB may identify the underlying etiology of persistent pulmonary disease and guide subsequent therapeutic decisions.
Read more
This observational study aims to evaluate the diagnostic yield, clinical utility, safety, and impact of flexible fiberoptic bronchoscopy with bronchoalveolar lavage in children with resistant pneumonia admitted to the Pediatric Intensive Care Unit at Abu El-Reesh Children's Hospital, Cairo University. Eligible patients are children who demonstrate persistent clinical and radiological evidence of pneumonia despite receiving at least five days of appropriate first-line broad-spectrum antibiotic therapy.
Clinical characteristics, bronchoscopic findings, microbiological results, bronchoalveolar lavage cultures, molecular diagnostic results, treatment modifications, procedure-related complications, and clinical outcomes will be analyzed. The findings of this study are expected to provide evidence regarding the role of flexible bronchoscopy in the diagnostic evaluation and management of resistant pneumonia in critically ill pediatric patients.
Read the detailed description
Lower respiratory tract infections remain a leading cause of morbidity and mortality among critically ill children admitted to Pediatric Intensive Care Units (PICUs). Despite appropriate empirical antimicrobial therapy, some patients continue to demonstrate persistent clinical and radiological evidence of pneumonia after at least five days of broad-spectrum antibiotic treatment. These patients are considered to have resistant or non-resolving pneumonia and often require additional diagnostic evaluation to identify persistent infection, resistant microorganisms, airway abnormalities, or alternative diagnoses.
Flexible fiberoptic bronchoscopy (FFB) with bronchoalveolar lavage (BAL) permits direct visualization of the tracheobronchial tree and collection of lower respiratory tract specimens for microbiological analysis. In addition to identifying airway abnormalities such as mucus plugging, tracheobronchitis, foreign body aspiration, airway malacia, or extrinsic airway compression, BAL specimens can be analyzed by conventional culture and molecular diagnostic methods to facilitate targeted antimicrobial therapy.
This prospective observational study was conducted in the Pediatric Intensive Care Unit of Abu El-Reesh Children's Hospital, Faculty of Medicine, Cairo University. Children aged 3 months to 14 years with resistant pneumonia who failed to improve clinically or radiologically after at least five days of first-line broad-spectrum antibiotic therapy and underwent clinically indicated flexible fiberoptic bronchoscopy with BAL were enrolled.
Clinical characteristics, laboratory investigations, inflammatory biomarkers, radiological findings, bronchoscopic findings, BAL microbiological results, antimicrobial susceptibility patterns, molecular diagnostic results, treatment modifications, procedure-related complications, and clinical outcomes were recorded and analyzed. The study evaluated the diagnostic yield and clinical utility of FFB with BAL, compared different microbiological diagnostic methods, assessed the impact of bronchoscopy on patient management, and evaluated clinical outcomes including inflammatory marker response, duration of oxygen therapy, length of PICU stay, and survival to PICU discharge.
The findings of this study contribute to understanding the diagnostic performance, safety, and clinical impact of flexible fiberoptic bronchoscopy with bronchoalveolar lavage in the evaluation and management of resistant pneumonia in critically ill pediatric patients.
- Being tested
- Flexible fiberoptic bronchoscopy with bronchoalveolar lavage (BAL)
- Keywords
- Flexible bronchoscopy; bronchoalveolar lavage; pediatric critical care; resistant pneumonia; diagnostic yield
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible fiberoptic bronchoscopy with bronchoalveolar lavage (BAL)Procedure or surgery
Flexible fiberoptic bronchoscopy with bronchoalveolar lavage was performed in all enrolled children with resistant pneumonia as part of the diagnostic evaluation. Bronchoscopy was used for direct airway visualization and bronchoalveolar lavage sample collection for microbiological analysis to guide subsequent clinical management.
| Study group | Role | What they receive |
|---|---|---|
| Children with resistant pneumonia undergoing flexible fiberoptic bronchoscopy | Children admitted to the Pediatric Intensive Care Unit (PICU) with resistant pneumonia who showed no clinical or radiological improvement after at least 5 days of broad-spectrum antibiotic therapy and underwent flexible fiberoptic bronchoscopy with bronchoalveolar lavage as part of their diagnostic evaluation. Receives: Procedure: Flexible fiberoptic bronchoscopy with bronchoalveolar lavage (BAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of flexible fiberoptic bronchoscopy (FFB) in resistant pneumonia
Proportion of patients in whom flexible fiberoptic bronchoscopy with bronchoalveolar lavage identifies a specific etiological pathogen (bacterial, viral, or fungal) responsible for resistant pneumonia
Measured: During bronchoscopy and within 72 hours after bronchoscopy where FFB findings were obtained during the procedure and inflammatory markers/chest imaging were reassessed within 72 hours after FFB, with patients followed clinically until PICU discharge
Secondary outcomes (3)
Clinical improvement after flexible fiberoptic bronchoscopy
Clinical improvement assessed by changes in C-reactive protein (CRP), total leukocyte count (TLC), chest radiographic findings, and oxygen requirement after flexible fiberoptic bronchoscopy.
Measured: 72 hours after bronchoscopy
Microbiological diagnostic performance of bronchoalveolar lavage
Comparison of bronchoalveolar lavage microbiological findings with sputum culture, blood culture, and molecular testing for pathogen identification.
Measured: Within 7 days after bronchoscopy
Clinical outcomes following bronchoscopy
Duration of oxygen therapy, length of PICU stay, treatment modification based on bronchoscopy findings, and mortality.
Measured: From bronchoscopy until PICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start5 Feb 2023
- Primary completion29 Jun 2025
- Study completion3 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Mansour Gomaa Mohammed Saleh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mansour Gomaa Mohammed Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421440
- Sponsor's protocol ID
- MD-207-2023
- Acronym
- FFP-RP PICU
- Status last verified
- Jul 2026
- First submitted
- 12 Feb 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the study contains patient-level clinical data and no formal data-sharing plan has been established.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Flexible Fiber Optic Bronchoscopy Usage in Children With Resistant Pneumonia in Pediatric Intensive Care Units (PICU )
- ClinicalTrials.gov ID
- NCT07421440
- Acronym / sponsor ID
- FFP-RP PICU / MD-207-2023
- Keywords
- Flexible bronchoscopy; bronchoalveolar lavage; pediatric critical care; resistant pneumonia; diagnostic yield
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mansour Gomaa Mohammed SalehUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 29 Jun 2025 (actual)
- Study completion
- 3 Aug 2025 (actual)
- First posted
- 19 Feb 2026 (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.
Pneumonia remains a leading cause of morbidity and mortality among critically ill children admitted to Pediatric Intensive Care Units (PICUs). A proportion of patients fail to demonstrate clinical or radiological improvement despite receiving at least five days of appropriate broad-spectrum antibiotic therapy, a condition commonly referred to as resistant or non-resolving pneumonia. These patients often require further diagnostic evaluation to identify persistent infection, resistant microorganisms, airway abnormalities, or alternative diagnoses.
Flexible fiberoptic bronchoscopy (FFB) with bronchoalveolar lavage (BAL) is an important diagnostic procedure that permits direct visualization of the tracheobronchial tree and collection of lower respiratory tract specimens for microbiological analysis. The findings obtained through FFB may identify the underlying etiology of persistent pulmonary disease and guide subsequent therapeutic decisions.
This observational study aims to evaluate the diagnostic yield, clinical utility, safety, and impact of flexible fiberoptic bronchoscopy with bronchoalveolar lavage in children with resistant pneumonia admitted to the Pediatric Intensive Care Unit at Abu El-Reesh Children's Hospital, Cairo University. Eligible patients are children who demonstrate persistent clinical and radiological evidence of pneumonia despite receiving at least five days of appropriate first-line broad-spectrum antibiotic therapy.
Clinical characteristics, bronchoscopic findings, microbiological results, bronchoalveolar lavage cultures, molecular diagnostic results, treatment modifications, procedure-related complications, and clinical outcomes will be analyzed. The findings of this study are expected to provide evidence regarding the role of flexible bronchoscopy in the diagnostic evaluation and management of resistant pneumonia in critically ill pediatric patients.
Detailed description
Lower respiratory tract infections remain a leading cause of morbidity and mortality among critically ill children admitted to Pediatric Intensive Care Units (PICUs). Despite appropriate empirical antimicrobial therapy, some patients continue to demonstrate persistent clinical and radiological evidence of pneumonia after at least five days of broad-spectrum antibiotic treatment. These patients are considered to have resistant or non-resolving pneumonia and often require additional diagnostic evaluation to identify persistent infection, resistant microorganisms, airway abnormalities, or alternative diagnoses.
Flexible fiberoptic bronchoscopy (FFB) with bronchoalveolar lavage (BAL) permits direct visualization of the tracheobronchial tree and collection of lower respiratory tract specimens for microbiological analysis. In addition to identifying airway abnormalities such as mucus plugging, tracheobronchitis, foreign body aspiration, airway malacia, or extrinsic airway compression, BAL specimens can be analyzed by conventional culture and molecular diagnostic methods to facilitate targeted antimicrobial therapy.
This prospective observational study was conducted in the Pediatric Intensive Care Unit of Abu El-Reesh Children's Hospital, Faculty of Medicine, Cairo University. Children aged 3 months to 14 years with resistant pneumonia who failed to improve clinically or radiologically after at least five days of first-line broad-spectrum antibiotic therapy and underwent clinically indicated flexible fiberoptic bronchoscopy with BAL were enrolled.
Clinical characteristics, laboratory investigations, inflammatory biomarkers, radiological findings, bronchoscopic findings, BAL microbiological results, antimicrobial susceptibility patterns, molecular diagnostic results, treatment modifications, procedure-related complications, and clinical outcomes were recorded and analyzed. The study evaluated the diagnostic yield and clinical utility of FFB with BAL, compared different microbiological diagnostic methods, assessed the impact of bronchoscopy on patient management, and evaluated clinical outcomes including inflammatory marker response, duration of oxygen therapy, length of PICU stay, and survival to PICU discharge.
The findings of this study contribute to understanding the diagnostic performance, safety, and clinical impact of flexible fiberoptic bronchoscopy with bronchoalveolar lavage in the evaluation and management of resistant pneumonia in critically ill pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with resistant pneumonia undergoing flexible fiberoptic bronchoscopy | – | Procedure: Flexible fiberoptic bronchoscopy with bronchoalveolar lavage (BAL)Children admitted to the Pediatric Intensive Care Unit (PICU) with resistant pneumonia who showed no clinical or radiological improvement after at least 5 days of broad-spectrum antibiotic therapy and underwent flexible fiberoptic bronchoscopy with bronchoalveolar lavage as part of their diagnostic evaluation. |
Who may qualify
- Ages
- 3 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 3 months to 18 years admitted to the Pediatric Intensive Care Unit at Abu El-Reesh Children's Hospital, Cairo University, with resistant pneumonia who underwent flexible fiberoptic bronchoscopy with bronchoalveolar lavage as part of their diagnostic evaluation
Key inclusion criteria (8 listed)
- - Children aged more than 3 months and less than 14 years.
- Admitted to Pediatric Intensive Care Unit (PICU).
- Severe pneumonia defined as cough or difficulty breathing with at least one of the following:
- 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.
Key exclusion criteria (3 listed)
- Age less than 3 months or more than 14 years.
- Absolute contraindication to flexible bronchoscopy (severe refractory hypoxemia, hemodynamic instability, uncorrected bleeding disorder).
- refusal of informed consent by parents or legal guardian
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 |
|---|---|---|
| Flexible fiberoptic bronchoscopy with bronchoalveolar lavage (BAL)Flexible fiberoptic bronchoscopy with bronchoalveolar lavage was performed in all enrolled children with resistant pneumonia as part of the diagnostic evaluation. Bronchoscopy was used for direct airway visualization and bronchoalveolar lavage sample collection for microbiological analysis to guide subsequent clinical management. | Procedure or surgery | Children with resistant pneumonia undergoing flexible fiberoptic bronchoscopy |
Primary outcome
Diagnostic yield of flexible fiberoptic bronchoscopy (FFB) in resistant pneumonia
Time frame: During bronchoscopy and within 72 hours after bronchoscopy where FFB findings were obtained during the procedure and inflammatory markers/chest imaging were reassessed within 72 hours after FFB, with patients followed clinically until PICU discharge
Proportion of patients in whom flexible fiberoptic bronchoscopy with bronchoalveolar lavage identifies a specific etiological pathogen (bacterial, viral, or fungal) responsible for resistant pneumonia
3 secondary outcomes
Clinical improvement after flexible fiberoptic bronchoscopy
Time frame: 72 hours after bronchoscopy
Microbiological diagnostic performance of bronchoalveolar lavage
Time frame: Within 7 days after bronchoscopy
Clinical outcomes following bronchoscopy
Time frame: From bronchoscopy until PICU discharge
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 20 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the study contains patient-level clinical data and no formal data-sharing plan has been established.
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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?
An observational study of Pneumonia and Resistant Pneumonia, run by Mansour Gomaa Mohammed Saleh 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 8 inclusion and 3 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 20 Jul 2026. 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.
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?
Diagnostic yield of flexible fiberoptic bronchoscopy (FFB) in resistant pneumonia (time frame: During bronchoscopy and within 72 hours after bronchoscopy where FFB findings were obtained during the procedure and inflammatory markers/chest imaging were reassessed within 72 hours after FFB, with patients followed clinically until PICU discharge). 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 20 Jul 2026.