Ventilator Associated Pneumonia ( VAP)Phase 4RCTNCT07369336
Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia
A Phase 4 study testing Amikacin (Inhalation) and Standard-of-Care Intravenous Antibiotics in people with Ventilator Associated Pneumonia ( VAP), run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
Trial summary
Article: Clinical Outcomes of Inhaled Amikacin in Ventilator-Associated Pneumonia: A group randomized controlled,add-on trial English:Patients in intensive care units often need ventilators to breathe. Sadly, these machines sometimes cause serious lung infections, known as ventilator-associated pneumonia (VAP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilator Associated Pneumonia ( VAP)
- What is being tested?
- Amikacin (Inhalation) and Standard-of-Care Intravenous Antibiotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2024to 30 Sep 2025
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following:
- Age 18-80 years
- Currently receiving invasive mechanical ventilation
- Clinical diagnosis of ventilator-associated pneumonia (VAP) based on:
- New or progressive infiltrate on chest imaging and at least two of the following:
- Fever > 38°C or hypothermia < 36°C
Show all 18Show fewer
- Leukocytosis >12,000 or leukopenia <4,000 cells/µL
- Increased purulent respiratory secretions
- Worsening oxygenation indices
- Initiation of systemic IV antibiotics for VAP
- Availability of baseline respiratory sample for culture
- Informed consent obtained from patient's legal guardian/attendantExclusion Criteria
- Any of the following will lead to exclusion:
- Known hypersensitivity to aminoglycosides (e.g., amikacin)
- Chronic kidney disease Stage 4-5 or baseline serum creatinine >2 mg/dL
- Pre-existing hearing loss or vestibular dysfunction
- Severe bronchospasm or airway instability preventing safe nebulization
- VAP due to confirmed pan-resistant microorganisms requiring alternative therapy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia:A Group Randomized Controlled, Add on Trial
Article: Clinical Outcomes of Inhaled Amikacin in Ventilator-Associated Pneumonia: A group randomized controlled,add-on trial English:Patients in intensive care units often need ventilators to breathe. Sadly, these machines sometimes cause serious lung infections, known as ventilator-associated pneumonia (VAP). This study tested whether giving the antibiotic amikacin by inhalation (so itgoes straight into the lungs) could improve recovery when added to regular treatment. Researchers looked at how quickly infections cleared, how long patients needed the ventilator, and whether hospital stays were shortened. They also monitored for side effects.
Read the detailed description
Ventilator-associated pneumonia continues to pose a significant therapeutic challenge due to rising antimicrobial resistance and suboptimal lung penetration of systemic antibiotics. Inhaled amikacin offers the advantage of delivering high local drug concentrations in the respiratory tract with minimal systemic toxicity.
This group randomized controlled add-on trial was conducted in the Surgical Intensive Care Units of Lahore General Hospital, Pakistan, from January to December 2024. A total of 180 adult patients diagnosed with VAP were allocated to one of two treatment arms:
Group N (Control): Empirical intravenous antibiotics (Meropenem ± Moxifloxacin)
Group A (Intervention): Inhaled amikacin (20 mg/kg/day in two divided doses) in addition to empirical intravenous antibiotics
Randomization was computer-generated and stratified by age, gender, and baseline SOFA score.
Clinical outcomes assessed included fever resolution, leukocyte normalization, reduced oxygen requirement, radiographic improvement, ventilator weaning, duration of mechanical ventilation, and length of ICU stay. Composite clinical improvement was defined as improvement in at least three out of five predefined domains.
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Being tested
- Amikacin (Inhalation), Standard-of-Care Intravenous Antibiotics
- Keywords
- Ventilator associated pneumonia, Inhaled amikacin, Mechanical ventilation, Adjunctive therapy, Clinical improvement
- 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.
Amikacin (Inhalation)Drug
Amikacin administered as an aerosolized solution via a vibrating mesh nebulizer once daily for the duration of systemic antibiotic therapy, according to ICU protocol for ventilator-associated pneumonia.
Standard-of-Care Intravenous AntibioticsDrug
Intravenous antibiotics selected based on local antimicrobial guidelines and pathogen sensitivity for ventilator-associated pneumonia, administered for the full
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Amikacin + Standard-of-Care Antibiotics | Experimental | Participants will receive inhaled amikacin administered via nebulization in addition to standard intravenous antibiotic therapy for ventilator-associated pneumonia. Therapy continues for the prescribed antibiotic course and according to unit protocol. Receives: Drug: Amikacin (Inhalation); Drug: Standard-of-Care Intravenous Antibiotics |
| Participants will receive ONLY standard of care antibiotics | Active comparator | Participants will receive only standard intravenous antibiotic therapy for ventilator-associated pneumonia. Therapy continues for the prescribed antibiotic course and according to unit protocol. Receives: Drug: Standard-of-Care Intravenous Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of invasive mechanical ventilation
The total number of consecutive days a participant remains on invasive mechanical ventilation following enrollment. Extubation is considered successful if the participant remains off the ventilator for at least 48 hours without the need for reintubation.
Measured: From randomization until successful discontinuation of mechanical ventilation, assessed up to 28 days
Secondary outcomes (1)
Clinical Improvement on Day 7
The proportion of participants achieving a predefined composite improvement in clinical status, including:
Reduction in sputum volume and purulence
Reduction in requirement for oxygen support
Improvement in PaO₂/FiO₂ ratio
Radiological improvement on chest imaging
Resolution of fever (temperature <38°C for >24 hours)
Measured using standardized clinical criteria for ventilator-associated pneumonia.
Measured: Day 7 after initiation of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start5 Jan 2024
- Primary completion25 Nov 2024
- Study completion30 Sep 2025
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized into two independent parallel groups.One group received standard empirical therapy ie. intravenous antibiotics, while the other group received inhaled amikacin in addition to same intravenous antibiotic regimen. Both groups were treated concurrently without crossover, allowing direct comparison of clinical outcomes between the two treatment strategies.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Medical Institute, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anum Anwar, Postgraduate Medical Institute, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369336
- Sponsor's protocol ID
- LGH/PGMI/AMC
- Acronym
- RCT
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this article may be shared upon reasonable request from qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia:A Group Randomized Controlled, Add on Trial
- ClinicalTrials.gov ID
- NCT07369336
- Acronym / sponsor ID
- RCT / LGH/PGMI/AMC
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Keywords
- Ventilator associated pneumonia, Inhaled amikacin, Mechanical ventilation, Adjunctive therapy, Clinical improvement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Postgraduate Medical Institute, LahoreUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 27 Jan 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.
Article: Clinical Outcomes of Inhaled Amikacin in Ventilator-Associated Pneumonia: A group randomized controlled,add-on trial English:Patients in intensive care units often need ventilators to breathe. Sadly, these machines sometimes cause serious lung infections, known as ventilator-associated pneumonia (VAP). This study tested whether giving the antibiotic amikacin by inhalation (so itgoes straight into the lungs) could improve recovery when added to regular treatment. Researchers looked at how quickly infections cleared, how long patients needed the ventilator, and whether hospital stays were shortened. They also monitored for side effects.
Detailed description
Ventilator-associated pneumonia continues to pose a significant therapeutic challenge due to rising antimicrobial resistance and suboptimal lung penetration of systemic antibiotics. Inhaled amikacin offers the advantage of delivering high local drug concentrations in the respiratory tract with minimal systemic toxicity.
This group randomized controlled add-on trial was conducted in the Surgical Intensive Care Units of Lahore General Hospital, Pakistan, from January to December 2024. A total of 180 adult patients diagnosed with VAP were allocated to one of two treatment arms:
Group N (Control): Empirical intravenous antibiotics (Meropenem ± Moxifloxacin)
Group A (Intervention): Inhaled amikacin (20 mg/kg/day in two divided doses) in addition to empirical intravenous antibiotics
Randomization was computer-generated and stratified by age, gender, and baseline SOFA score.
Clinical outcomes assessed included fever resolution, leukocyte normalization, reduced oxygen requirement, radiographic improvement, ventilator weaning, duration of mechanical ventilation, and length of ICU stay. Composite clinical improvement was defined as improvement in at least three out of five predefined domains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized into two independent parallel groups.One group received standard empirical therapy ie. intravenous antibiotics, while the other group received inhaled amikacin in addition to same intravenous antibiotic regimen. Both groups were treated concurrently without crossover, allowing direct comparison of clinical outcomes between the two treatment strategies.
| Arm | Type | Receives |
|---|---|---|
| Inhaled Amikacin + Standard-of-Care Antibiotics | Experimental | Drug: Amikacin (Inhalation), Drug: Standard-of-Care Intravenous AntibioticsParticipants will receive inhaled amikacin administered via nebulization in addition to standard intravenous antibiotic therapy for ventilator-associated pneumonia. Therapy continues for the prescribed antibiotic course and according to unit protocol. |
| Participants will receive ONLY standard of care antibiotics | Active comparator | Drug: Standard-of-Care Intravenous AntibioticsParticipants will receive only standard intravenous antibiotic therapy for ventilator-associated pneumonia. Therapy continues for the prescribed antibiotic course and according to unit protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age 18-80 years
- Currently receiving invasive mechanical ventilation
- Clinical diagnosis of ventilator-associated pneumonia (VAP) based on:
- Fever > 38°C or hypothermia < 36°C
- Leukocytosis >12,000 or leukopenia <4,000 cells/µL
Key exclusion criteria (1 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 |
|---|---|---|
| Amikacin (Inhalation)Amikacin administered as an aerosolized solution via a vibrating mesh nebulizer once daily for the duration of systemic antibiotic therapy, according to ICU protocol for ventilator-associated pneumonia. | Drug | Inhaled Amikacin + Standard-of-Care Antibiotics |
| Standard-of-Care Intravenous AntibioticsIntravenous antibiotics selected based on local antimicrobial guidelines and pathogen sensitivity for ventilator-associated pneumonia, administered for the full | Drug | Inhaled Amikacin + Standard-of-Care Antibiotics, Participants will receive ONLY standard of care antibiotics |
Primary outcome
Duration of invasive mechanical ventilation
Time frame: From randomization until successful discontinuation of mechanical ventilation, assessed up to 28 days
The total number of consecutive days a participant remains on invasive mechanical ventilation following enrollment. Extubation is considered successful if the participant remains off the ventilator for at least 48 hours without the need for reintubation.
1 secondary outcome
Clinical Improvement on Day 7
Time frame: Day 7 after initiation of study treatment
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 27 Jan 2026.
- https://sites.google.com/view/inhaled-amikacin-vap-dataLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this article may be shared upon reasonable request from qualified researchers.
Related trials for Ventilator Associated Pneumonia ( VAP)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
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Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
Ventilator Associated Pneumonia ( VAP)
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 4 study testing Amikacin (Inhalation) and Standard-of-Care Intravenous Antibiotics in people with Ventilator Associated Pneumonia ( VAP), run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
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 18 inclusion and 1 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 27 Jan 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 Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Duration of invasive mechanical ventilation (time frame: From randomization until successful discontinuation of mechanical ventilation, assessed up to 28 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 27 Jan 2026.