Ventilator-Associated PneumoniaNCT07149909
Fiberoptic Bronchoscopy in Severe Ventilator-associated Pneumonia
A study testing Other (Conventional Therapy) and Fiberoptic Bronchoscopy in people with Ventilator-Associated Pneumonia and Severe Pneumonia, run by Benha University at 1 site in Egypt.
Trial summary
This randomized controlled trial evaluated the clinical effect of fiberoptic bronchoscopy in the management of adult patients with severe ventilator-associated pneumonia (VAP). A total of 100 patients admitted to the Critical Care Department at Benha University Hospitals were enrolled and randomly assigned in equal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ventilator-Associated Pneumonia, Severe Pneumonia, Critical Illness
- What is being tested?
- Other (Conventional Therapy) and Fiberoptic Bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2023to 15 Dec 2024
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Patients of both sexes
- Patients requiring mechanical ventilation
- Development of pneumonia ≥ 48 hours after endotracheal intubation or ≥ 48 hours after extubation
- Diagnosis of severe ventilator-associated pneumonia defined by a Modified Clinical Pulmonary Infection Score (CPIS) > 6
Who cannot join
- Refusal to participate
- Presence of lung shadows prior to mechanical ventilation
- Severe bleeding disorders or immune system diseases
- Severe hemodynamic instability
- Recent myocardial infarction or unstable arrhythmia
- Tracheal stenosis or upper airway mass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Effect of Fiberoptic Bronchoscopy in Management of Adult Patients With Severe Ventilator-associated Pneumonia; a Randomized Controlled Trial
This randomized controlled trial evaluated the clinical effect of fiberoptic bronchoscopy in the management of adult patients with severe ventilator-associated pneumonia (VAP). A total of 100 patients admitted to the Critical Care Department at Benha University Hospitals were enrolled and randomly assigned in equal numbers to two groups. The control group received standard therapy, including culture-guided antibiotics, lavage, and aspiration. The intervention group received the same treatment plus fiberoptic bronchoscopy for secretion clearance, lavage, and culture-directed antibiotic therapy.
The primary outcome was the overall effective treatment rate, defined as the proportion of patients with significant or partial clinical improvement. Secondary outcomes included recovery time, length of intensive care unit stay, respiratory mechanics, inflammatory markers (C-reactive protein and procalcitonin), recurrence of pulmonary infection, and 28-day mortality.
The study demonstrated whether the addition of fiberoptic bronchoscopy to conventional treatment improved clinical outcomes in patients with severe ventilator-associated pneumonia.
- Being tested
- Other (Conventional Therapy), Fiberoptic Bronchoscopy
- Keywords
- Fiberoptic bronchoscopy, Bronchoalveolar lavage (BAL), Mechanical ventilation, Intensive care unit (ICU), Respiratory infection, Secretion clearance, Culture-directed antibiotics, Severe VAP
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia, Critical Illness, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other (Conventional Therapy)Other
Participants received standard therapy including culture-guided antibiotics, tracheal lavage, and aspiration. Sputum samples were collected from the lower trachea for culture and sensitivity testing to guide antibiotic selection.
Fiberoptic BronchoscopyProcedure or surgery
Participants underwent fiberoptic bronchoscopy through the endotracheal tube for secretion clearance, sample collection, and alveolar lavage once daily for one week. Sterile sodium chloride solution with ambroxol hydrochloride was instilled, and antibiotics were administered immediately after lavage. Samples were cultured to guide antibiotic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants received standard therapy for severe ventilator-associated pneumonia, which included culture-guided antibiotics, routine drug therapy, tracheal lavage, and aspiration. Sputum samples were collected for bacterial culture and sensitivity testing to guide antibiotic selection. Receives: Other: Other (Conventional Therapy) |
| Fiberoptic Bronchoscopy Group | Experimental | Participants received the same standard therapy as the control group plus fiberoptic bronchoscopy. The bronchoscope was inserted via the endotracheal tube to clear secretions, obtain samples for culture, and perform bronchoscopic alveolar lavage. Lavage was performed once daily for one week using sterile sodium chloride solution with ambroxol hydrochloride, followed by antibiotic administration. Cultures were used to guide therapy. Receives: Procedure: Fiberoptic Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Effective Treatment Rate
Proportion of patients achieving significant or partial clinical improvement based on resolution of symptoms, normalization of temperature and laboratory markers, negative sputum cultures, and radiologic improvement.
Measured: Postoperatively (within 28 days of VAP diagnosis).
Secondary outcomes (2)
Recovery Time
Duration from diagnosis of ventilator-associated pneumonia (VAP) until Modified Clinical Pulmonary Infection Score (CPIS) decreased to below 6.
Measured: Up to 28 days from diagnosis.
Length of intensive care unit (ICU) stay
Total number of days spent in the intensive care unit during the hospital admission.
Measured: From intensive care unit (ICU) admission until discharge (maximum 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start15 Dec 2023
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to receive either standard therapy alone or standard therapy plus fiberoptic bronchoscopy.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Mohamed Mohsen Mahmoud, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149909
- Sponsor's protocol ID
- MD: 8-11-2023
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (de-identified) that underlie the results reported in this trial will be made available to qualified researchers upon reasonable request for the purpose of meta-analyses and further research on ventilator-associated pneumonia management.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of Fiberoptic Bronchoscopy in Management of Adult Patients With Severe Ventilator-associated Pneumonia; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07149909
- Acronym / sponsor ID
- MD: 8-11-2023
- Keywords
- Fiberoptic bronchoscopy, Bronchoalveolar lavage (BAL), Mechanical ventilation, Intensive care unit (ICU), Respiratory infection, Secretion clearance, Culture-directed antibiotics, Severe VAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 2 Sep 2025 (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.
This randomized controlled trial evaluated the clinical effect of fiberoptic bronchoscopy in the management of adult patients with severe ventilator-associated pneumonia (VAP). A total of 100 patients admitted to the Critical Care Department at Benha University Hospitals were enrolled and randomly assigned in equal numbers to two groups. The control group received standard therapy, including culture-guided antibiotics, lavage, and aspiration. The intervention group received the same treatment plus fiberoptic bronchoscopy for secretion clearance, lavage, and culture-directed antibiotic therapy.
The primary outcome was the overall effective treatment rate, defined as the proportion of patients with significant or partial clinical improvement. Secondary outcomes included recovery time, length of intensive care unit stay, respiratory mechanics, inflammatory markers (C-reactive protein and procalcitonin), recurrence of pulmonary infection, and 28-day mortality.
The study demonstrated whether the addition of fiberoptic bronchoscopy to conventional treatment improved clinical outcomes in patients with severe ventilator-associated pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to receive either standard therapy alone or standard therapy plus fiberoptic bronchoscopy.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Other (Conventional Therapy)Participants received standard therapy for severe ventilator-associated pneumonia, which included culture-guided antibiotics, routine drug therapy, tracheal lavage, and aspiration. Sputum samples were collected for bacterial culture and sensitivity testing to guide antibiotic selection. |
| Fiberoptic Bronchoscopy Group | Experimental | Procedure: Fiberoptic BronchoscopyParticipants received the same standard therapy as the control group plus fiberoptic bronchoscopy. The bronchoscope was inserted via the endotracheal tube to clear secretions, obtain samples for culture, and perform bronchoscopic alveolar lavage. Lavage was performed once daily for one week using sterile sodium chloride solution with ambroxol hydrochloride, followed by antibiotic administration. Cultures were used to guide therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years
- Patients of both sexes
- Patients requiring mechanical ventilation
- Development of pneumonia ≥ 48 hours after endotracheal intubation or ≥ 48 hours after extubation
- Diagnosis of severe ventilator-associated pneumonia defined by a Modified Clinical Pulmonary Infection Score (CPIS) > 6
Key exclusion criteria (6 listed)
- Refusal to participate
- Presence of lung shadows prior to mechanical ventilation
- Severe bleeding disorders or immune system diseases
- Severe hemodynamic instability
- Recent myocardial infarction or unstable arrhythmia
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 |
|---|---|---|
| Other (Conventional Therapy)Participants received standard therapy including culture-guided antibiotics, tracheal lavage, and aspiration. Sputum samples were collected from the lower trachea for culture and sensitivity testing to guide antibiotic selection. | Other | Control Group |
| Fiberoptic BronchoscopyParticipants underwent fiberoptic bronchoscopy through the endotracheal tube for secretion clearance, sample collection, and alveolar lavage once daily for one week. Sterile sodium chloride solution with ambroxol hydrochloride was instilled, and antibiotics were administered immediately after lavage. Samples were cultured to guide antibiotic therapy. | Procedure or surgery | Fiberoptic Bronchoscopy Group |
Primary outcome
Overall Effective Treatment Rate
Time frame: Postoperatively (within 28 days of VAP diagnosis).
Proportion of patients achieving significant or partial clinical improvement based on resolution of symptoms, normalization of temperature and laboratory markers, negative sputum cultures, and radiologic improvement.
2 secondary outcomes
Recovery Time
Time frame: Up to 28 days from diagnosis.
Length of intensive care unit (ICU) stay
Time frame: From intensive care unit (ICU) admission until discharge (maximum 28 days).
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 2 Sep 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (de-identified) that underlie the results reported in this trial will be made available to qualified researchers upon reasonable request for the purpose of meta-analyses and further research on ventilator-associated pneumonia management.
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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?
A study testing Other (Conventional Therapy) and Fiberoptic Bronchoscopy in people with Ventilator-Associated Pneumonia and Severe Pneumonia, run by Benha 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 5 inclusion and 6 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 2 Sep 2025. 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?
Overall Effective Treatment Rate (time frame: Postoperatively (within 28 days of VAP diagnosis).). 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 2 Sep 2025.