Ventilator Associated Pneumonia ( VAP)Early Phase 1NCT07865871
Role of Inhaled Polymyxin as an Adjunct to Intravenous Therapy in Multidrug Resistant Ventilator-associated Pneumonia in Stroke Patients
A Early Phase 1 study testing Inhaled colistin and Saline in people with Ventilator Associated Pneumonia ( VAP), run by Ain Shams University.
Trial summary
This study investigates whether adjunctive inhaled colistin enhances clinical recovery and microbiological clearance in multidrug resistant ventilator-associated pneumonia in stroke patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia ( VAP)
- What is being tested?
- Inhaled colistin and Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 10 Oct 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria :adult patients, who were admitted to stroke care unit with the diagnosis of CT or MRI evidenced stroke during the study period with confirmed MDR-GNB pneumonia by culutre and sensitivity requiring intravenous antibiotic therapy, hemodynamically stable at the time of enrollment, and willing to provide informed consent (from legal guardian).
-
Exclusion Criteria: Known hypersensitivity to colistin, pregnancy, pre-existing severe renal impairment (CKD stages IV-V or requiring renal replacement therapy), severe immunosuppression, or refusal to participate.
- Patients with cultures sensitive to colistin will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study investigates whether adjunctive inhaled colistin enhances clinical recovery and microbiological clearance in multidrug resistant ventilator-associated pneumonia in stroke patients
Read the detailed description
This will be a prospective, comparative study conducted in the Intensive Care Unit (ICU) of Ain shams university hospitals, over a period of one year. Adult stroke patients diagnosed with ventilator-associated pneumonia (VAP) due to multidrug-resistant Gram-negative bacteria (MDR-GNB) will be screened for eligibility. The diagnosis will be established based on clinical features, radiological evidence, and microbiological confirmation.
Ventilator-associated pneumonia (VAP) is diagnosed based on a combination of clinical, radiological, and microbiological criteria, according to the American thoracic society (ATS)and Infectious diseases society of America(IDSA) guidelines (2016), the diagnosis requires a patient ventilated ≥48 hours with a new or worsening pulmonary infiltrate on chest radiograph, plus at least one of the following: fever or hypothermia, leukocytosis or leukopenia, purulent tracheal secretions, or a decline in oxygenation. Microbiologic confirmation via non-invasive semiquantitative cultures of respiratory secretions is recommended over invasive techniques when feasible.
All patients will receive Ventilator-Associated Pneumonia (VAP) bundle care as part of the standard ICU management .
Eligible patients will be allocated into two groups:
- Group A: Patients will receive intravenous antibiotics alone, without nebulized colistin plus inhaled saline. Standred intravenous antibiotics will be given according to culture and sensitivity and ICU protocol.
- Group B: Patients will receive nebulized colistin in addition to standard intravenous antibiotics according to ICU protocol.
Adults will receive 2.5 mg/kg daily in divided doses every 6 hours for adjunctive treatment of respiratory tract infections .If a 0.5% solution of the drug is prepared using 0.9% sodium chloride and this dosage regimen is used, the average 70-kg patient would receive 6 mL of solution per dose . Adults will receive 500,000 units twice daily given approximately 20 minutes after an oral inhalation dose of a β2-adrenergic agonist.
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Being tested
- Inhaled colistin, Saline
- Keywords
- VAP in stroke patients
- 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.
Inhaled colistinDrug
group B will recieve inhaled colistin with intravenous antibiotics and group A will recieve the intravenous antibiotics with inhaled saline
SalineDrug
group A will recieve the intravenous antibiotics with inhaled saline
| Study group | Role | What they receive |
|---|---|---|
| control group A | Placebo comparator | Patients will receive intravenous antibiotics alone, without nebulized colistin plus inhaled saline. Standred intravenous antibiotics will be given according to culture and sensitivity and ICU protocol. Receives: Drug: Saline |
| intervention group B | Experimental | Patients will receive nebulized colistin in addition to standard intravenous antibiotics according to ICU protocol.
Adults will receive 2.5 mg/kg daily in divided doses every 6 hours for adjunctive treatment of respiratory tract infections .If a 0.5% solution of the drug is prepared using 0.9% sodium chloride and this dosage regimen is used, the average 70-kg patient would receive 6 mL of solution per dose( Karaiskos I, et al.2023) . Adults will receive 500,000 units twice daily given approximately 20 minutes after an oral inhalation dose of a β2-adrenergic agonist. Receives: Drug: Inhaled colistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome is the clinical response
Clinical outcome was classified as clinical cure, clinical improvement, and clinical failure according to clinical pulmonary infection score (CPIS) (Mondal, M.K. and Dutta, S., 2025).
Acute phase reactants (CRP and procalcitonin) will be assessed every 48 hours, while serum lactate will be measured daily to monitor the patient's metabolic status and response to therapy to correlate their trends with clinical outcomes.
Clinical pulmonary infection score (CPIS):
The CPIS will be calculated at baseline and on Daily basis of therapy, using six components (temperature, blood leukocyte count, tracheal secretions, PaO₂/FiO₂ ratio, chest radiograph, and tracheal aspirate culture), with scores ranging from 0-12.
Parameter 0 points 1 point 2 points Temperature (°C) 36.5-38.4 38.5-38.9 or 36.0-36.4 ≥39.0 or ≤35.9 Blood leukocytes (cells/µL) 4,000-11,000 <4,000 or >11,000 <4,000 or >11,000 plus band forms ≥50% Tracheal secretions Rare Abundant Abundant + purulent PaO₂/FiO₂ ratio (mmHg) >240 o
Measured: two weeks from the start
Secondary outcomes (1)
Microbiological eradication
- Eradication of the pathogen: No pathogen growth was observed in the final culture of specimens following colistin treatment.
- Persistence of the pathogen: Continued growth of the identified pathogen in culture after colistin treatment.
- Recurrence (regrowth) of the pathogen: Isolation of the same pathogen identified in the initial culture following subsequent negative cultures during colistin treatment.
Measured: two weeks from the start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated Pneumonia ( VAP)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865871
- Sponsor's protocol ID
- FMASU MD399/2025
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inhaled Polymyxin as an Adjunct to Intravenous Therapy in Multidrug Resistant Ventilator-associated Pneumonia in Stroke Patients
- ClinicalTrials.gov ID
- NCT07865871
- Acronym / sponsor ID
- FMASU MD399/2025
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Keywords
- VAP in stroke patients
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 8 Oct 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.
This study investigates whether adjunctive inhaled colistin enhances clinical recovery and microbiological clearance in multidrug resistant ventilator-associated pneumonia in stroke patients
Detailed description
This will be a prospective, comparative study conducted in the Intensive Care Unit (ICU) of Ain shams university hospitals, over a period of one year. Adult stroke patients diagnosed with ventilator-associated pneumonia (VAP) due to multidrug-resistant Gram-negative bacteria (MDR-GNB) will be screened for eligibility. The diagnosis will be established based on clinical features, radiological evidence, and microbiological confirmation.
Ventilator-associated pneumonia (VAP) is diagnosed based on a combination of clinical, radiological, and microbiological criteria, according to the American thoracic society (ATS)and Infectious diseases society of America(IDSA) guidelines (2016), the diagnosis requires a patient ventilated ≥48 hours with a new or worsening pulmonary infiltrate on chest radiograph, plus at least one of the following: fever or hypothermia, leukocytosis or leukopenia, purulent tracheal secretions, or a decline in oxygenation. Microbiologic confirmation via non-invasive semiquantitative cultures of respiratory secretions is recommended over invasive techniques when feasible.
All patients will receive Ventilator-Associated Pneumonia (VAP) bundle care as part of the standard ICU management .
Eligible patients will be allocated into two groups:
- Group A: Patients will receive intravenous antibiotics alone, without nebulized colistin plus inhaled saline. Standred intravenous antibiotics will be given according to culture and sensitivity and ICU protocol.
- Group B: Patients will receive nebulized colistin in addition to standard intravenous antibiotics according to ICU protocol.
Adults will receive 2.5 mg/kg daily in divided doses every 6 hours for adjunctive treatment of respiratory tract infections .If a 0.5% solution of the drug is prepared using 0.9% sodium chloride and this dosage regimen is used, the average 70-kg patient would receive 6 mL of solution per dose . Adults will receive 500,000 units twice daily given approximately 20 minutes after an oral inhalation dose of a β2-adrenergic agonist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group A | Placebo comparator | Drug: SalinePatients will receive intravenous antibiotics alone, without nebulized colistin plus inhaled saline. Standred intravenous antibiotics will be given according to culture and sensitivity and ICU protocol. |
| intervention group B | Experimental | Drug: Inhaled colistinPatients will receive nebulized colistin in addition to standard intravenous antibiotics according to ICU protocol. Adults will receive 2.5 mg/kg daily in divided doses every 6 hours for adjunctive treatment of respiratory tract infections .If a 0.5% solution of the drug is prepared using 0.9% sodium chloride and this dosage regimen is used, the average 70-kg patient would receive 6 mL of solution per dose( Karaiskos I, et al.2023) . Adults will receive 500,000 units twice daily given approximately 20 minutes after an oral inhalation dose of a β2-adrenergic agonist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Inhaled colistingroup B will recieve inhaled colistin with intravenous antibiotics and group A will recieve the intravenous antibiotics with inhaled saline | Drug | intervention group B |
| Salinegroup A will recieve the intravenous antibiotics with inhaled saline | Drug | control group A |
Primary outcome
primary outcome is the clinical response
Time frame: two weeks from the start
Clinical outcome was classified as clinical cure, clinical improvement, and clinical failure according to clinical pulmonary infection score (CPIS) (Mondal, M.K. and Dutta, S., 2025). Acute phase reactants (CRP and procalcitonin) will be assessed every 48 hours, while serum lactate will be measured daily to monitor the patient's metabolic status and response to therapy to correlate their trends with clinical outcomes. Clinical pulmonary infection score (CPIS): The CPIS will be calculated at baseline and on Daily basis of therapy, using six components (temperature, blood leukocyte count, tracheal secretions, PaO₂/FiO₂ ratio, chest radiograph, and tracheal aspirate culture), with scores ranging from 0-12. Parameter 0 points 1 point 2 points Temperature (°C) 36.5-38.4 38.5-38.9 or 36.0-36.4 ≥39.0 or ≤35.9 Blood leukocytes (cells/µL) 4,000-11,000 <4,000 or >11,000 <4,000 or >11,000 plus band forms ≥50% Tracheal secretions Rare Abundant Abundant + purulent PaO₂/FiO₂ ratio (mmHg) >240 o
1 secondary outcome
Microbiological eradication
Time frame: two weeks from the start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Not yet recruitingObservational study
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Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Inhaled colistin and Saline in people with Ventilator Associated Pneumonia ( VAP), run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yumna ahmed hegazy, master degree (01093234317, yumna.hegazy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome is the clinical response (time frame: two weeks from the start). 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 8 Oct 2026.